Trial Outcomes & Findings for PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers (NCT NCT04515875)
NCT ID: NCT04515875
Last Updated: 2026-07-15
Results Overview
The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
420 participants
Primary outcome timeframe
Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
Results posted on
2026-07-15
Participant Flow
Initial study approval was January 20th 2021. However, recruitment approaches transitioned from in-person approach to over the telephone due to COVID-19 and competing studies. Recruitment began 12/13/2021 and ended on 7/18/2025. Recruitment locations included in-clinic referrals, healthcare service databases, community organization partnerships, volunteer participant registries, among others.
Before randomization and baseline data collection, a total of 22 enrolled and consented participants (11 patient-caregiver dyads) withdrew from the study. Reasons: did not wish to continue (n=9), lost to follow-up (n=1), and other (n=1).
Participant milestones
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
99
|
99
|
|
Overall Study
COMPLETED
|
84
|
84
|
83
|
83
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
16
|
16
|
Reasons for withdrawal
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
8
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
6
|
6
|
|
Overall Study
Patient participant passed away
|
1
|
1
|
2
|
2
|
Baseline Characteristics
Not collected on caregivers; only collected on patient participants.
Baseline characteristics by cohort
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 6.9 • n=100 Participants
|
64.8 years
STANDARD_DEVIATION 13.9 • n=100 Participants
|
73.3 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
65.1 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
69.1 years
STANDARD_DEVIATION 10.9 • n=398 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=100 Participants
|
71 Participants
n=100 Participants
|
48 Participants
n=99 Participants
|
70 Participants
n=99 Participants
|
236 Participants
n=398 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=100 Participants
|
29 Participants
n=100 Participants
|
51 Participants
n=99 Participants
|
29 Participants
n=99 Participants
|
162 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
1 Participants
n=99 Participants
|
1 Participants
n=99 Participants
|
6 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=100 Participants
|
98 Participants
n=100 Participants
|
98 Participants
n=99 Participants
|
98 Participants
n=99 Participants
|
392 Participants
n=398 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=398 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=100 Participants
|
2 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=99 Participants
|
3 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=100 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=99 Participants
|
2 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=100 Participants
|
5 Participants
n=100 Participants
|
9 Participants
n=99 Participants
|
10 Participants
n=99 Participants
|
31 Participants
n=398 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=100 Participants
|
88 Participants
n=100 Participants
|
87 Participants
n=99 Participants
|
86 Participants
n=99 Participants
|
350 Participants
n=398 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=99 Participants
|
5 Participants
n=398 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
4 Participants
n=100 Participants
|
2 Participants
n=99 Participants
|
1 Participants
n=99 Participants
|
7 Participants
n=398 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
99 participants
n=99 Participants
|
99 participants
n=99 Participants
|
398 participants
n=398 Participants
|
|
Patient Montreal Cognitive Assessment (MoCA)[1]
|
21.5 score on a scale
STANDARD_DEVIATION 3.5 • n=100 Participants • Not collected on caregivers; only collected on patient participants.
|
—
|
21.1 score on a scale
STANDARD_DEVIATION 3.5 • n=99 Participants • Not collected on caregivers; only collected on patient participants.
|
—
|
21.3 score on a scale
STANDARD_DEVIATION 3.5 • n=199 Participants • Not collected on caregivers; only collected on patient participants.
|
PRIMARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline, 10 days post-program, 3 months post-program, and 6 months post-program for each patient with mild cognitive impairment (PwMCI) and each caregiver active on study at that time point to respond.
The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately.
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Life Satisfaction (LSITA)
3 months post-intervention
|
43.81 score on a scale
Standard Deviation 5.28
|
44.41 score on a scale
Standard Deviation 5.03
|
43.31 score on a scale
Standard Deviation 5.88
|
44.34 score on a scale
Standard Deviation 5.30
|
|
Life Satisfaction (LSITA)
Baseline
|
43.61 score on a scale
Standard Deviation 5.26
|
44.15 score on a scale
Standard Deviation 4.39
|
43.14 score on a scale
Standard Deviation 5.72
|
44.27 score on a scale
Standard Deviation 5.06
|
|
Life Satisfaction (LSITA)
10 days post-intervention
|
44.69 score on a scale
Standard Deviation 5.52
|
44.52 score on a scale
Standard Deviation 5.10
|
43.68 score on a scale
Standard Deviation 5.25
|
44.01 score on a scale
Standard Deviation 4.93
|
|
Life Satisfaction (LSITA)
6 months post-intervention
|
44.58 score on a scale
Standard Deviation 5.03
|
44.40 score on a scale
Standard Deviation 5.55
|
43.23 score on a scale
Standard Deviation 5.79
|
44.04 score on a scale
Standard Deviation 4.85
|
SECONDARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline, 10 days post-program, 3 months post-program, and 6 months post-program for each patient with mild cognitive impairment (PwMCI) and each caregiver active on study at that time point to respond.
Patient Health Questionnaire-9 Items (PHQ-9) is used to measure emotional function (Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 contains nine questions about symptoms. It has been widely used in older populations. The depression severity levels are: The scores 0 -4 indicate none, the scores between 5 to 9 indicate mild depression; the score between 10-14 indicates moderate depression; the scores between 15 to 19 indicate moderately severe depression, the scores between 20 to 27 indicate severe depression. The internal reliability was 0.83 to 0.92 (Kroenke et al., 2001). The scale takes about 3 minutes to complete it. The PHQ-9 is completed by patient and caregiver separately.Total scores range from 0 to 27, with higher scores indicating increased severity.
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-9 Items (PHQ-9)
Baseline
|
5.11 score on a scale
Standard Deviation 4.27
|
3.38 score on a scale
Standard Deviation 3.29
|
5.09 score on a scale
Standard Deviation 4.37
|
2.98 score on a scale
Standard Deviation 3.00
|
|
Patient Health Questionnaire-9 Items (PHQ-9)
10 days post-intervention
|
4.72 score on a scale
Standard Deviation 4.60
|
2.66 score on a scale
Standard Deviation 2.95
|
4.68 score on a scale
Standard Deviation 3.96
|
2.88 score on a scale
Standard Deviation 3.21
|
|
Patient Health Questionnaire-9 Items (PHQ-9)
3 months post-intervention
|
4.82 score on a scale
Standard Deviation 4.63
|
3.17 score on a scale
Standard Deviation 3.30
|
4.58 score on a scale
Standard Deviation 4.47
|
2.75 score on a scale
Standard Deviation 3.22
|
|
Patient Health Questionnaire-9 Items (PHQ-9)
6 months post-intervention
|
4.48 score on a scale
Standard Deviation 4.57
|
3.07 score on a scale
Standard Deviation 3.23
|
4.24 score on a scale
Standard Deviation 4.37
|
2.72 score on a scale
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline, 10 days post-program, 3 months post-program, and 6 months post-program for each patient with mild cognitive impairment (PwMCI) and each caregiver active on study at that time point to respond. T
The General Anxiety Disorder 7-item (GAD-7), four-point Liker scale is used to measure emotional function and it contains 7 questions about anxiety (Spitzer, Kroenke, Williams, \& Lowe, 2006). It has been widely used in older populations. The GAD-7 scale score ranges from 0 to 21 and high scores indicates perceiving high level of anxiety. The internal reliability was 0.92 and test-retest reliability was 0.83 (Spitzer et al., 2006). The scale takes about 3 minutes to complete it. The GAD-7is completed by patient and caregiver separately.
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
The General Anxiety Disorder 7-item (GAD-7)
10 days post-intervention
|
3.83 score on a scale
Standard Deviation 4.12
|
2.97 score on a scale
Standard Deviation 3.45
|
3.09 score on a scale
Standard Deviation 3.49
|
3.36 score on a scale
Standard Deviation 3.79
|
|
The General Anxiety Disorder 7-item (GAD-7)
6 months post-intervention
|
3.54 score on a scale
Standard Deviation 4.36
|
3.00 score on a scale
Standard Deviation 3.50
|
2.73 score on a scale
Standard Deviation 3.35
|
2.84 score on a scale
Standard Deviation 3.70
|
|
The General Anxiety Disorder 7-item (GAD-7)
Baseline
|
4.28 score on a scale
Standard Deviation 4.46
|
3.94 score on a scale
Standard Deviation 3.88
|
3.18 score on a scale
Standard Deviation 3.25
|
3.46 score on a scale
Standard Deviation 3.66
|
|
The General Anxiety Disorder 7-item (GAD-7)
3 months post-intervention
|
3.42 score on a scale
Standard Deviation 3.85
|
3.27 score on a scale
Standard Deviation 4.13
|
3.17 score on a scale
Standard Deviation 3.90
|
2.87 score on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline, 10 days post-program, 3 months post-program, and 6 months post-program for each patient with mild cognitive impairment (PwMCI) on study at that time point to respond.
The 23-item ADCS-MCI-ADL Scale has good test-retest reliability, will be utilized to assess performance functioning in MCI patients (Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The ADCS-ADL includes 18 items from traditional basic ADL scales and 5 items from instrumental activities of daily living scales (IADL) The possible range of total scores for the ADL Scale is 0-53 and higher scores indicate better functioning. The internal reliability was .91( Galasko et al., 1997; Douglas Galasko et al., 2006; Pedrosa et al., 2010). The scale takes about 15 minutes to complete it.
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=99 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
Baseline
|
50.48 score on a scale
Standard Deviation 10.30
|
48.69 score on a scale
Standard Deviation 11.14
|
—
|
—
|
|
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
10 days post-intervention
|
51.31 score on a scale
Standard Deviation 10.47
|
48.63 score on a scale
Standard Deviation 12.73
|
—
|
—
|
|
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
3 months post-intervention
|
50.39 score on a scale
Standard Deviation 11.70
|
48.24 score on a scale
Standard Deviation 13.47
|
—
|
—
|
|
Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
6 months post-intervention
|
50.73 score on a scale
Standard Deviation 11.70
|
47.90 score on a scale
Standard Deviation 13.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline,10 days post-program, 3 months post-program, and 6 months post-program for each patient with mild cognitive impairment (PwMCI) and each caregiver active on study at that time point to respond.
The Relationship Assessment Scale is a 7-item, 5 points Likert scale designed to measure general relationship satisfaction (Graham, Kunik, Doody, \& Snow, 2005). The RAS was produces more reliable scores when administered to older individuals, older relationship, and married couples but it was intended to be applicable to a wide range of relationship types (Graham et al., 2005). Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). Total scores range from 7 to 35, with higher scores indicating better relationship satisfaction. The internal reliability was .86-.87. The scale takes about 3 minutes to complete it.
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
n=99 Participants
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Relationship Assessment Scale (RAS)
6 months post-intervention
|
31.73 score on a scale
Standard Deviation 4.32
|
29.80 score on a scale
Standard Deviation 5.07
|
31.16 score on a scale
Standard Deviation 4.75
|
29.24 score on a scale
Standard Deviation 5.03
|
|
Relationship Assessment Scale (RAS)
Baseline
|
30.89 score on a scale
Standard Deviation 4.45
|
29.04 score on a scale
Standard Deviation 5.31
|
30.82 score on a scale
Standard Deviation 4.62
|
28.54 score on a scale
Standard Deviation 5.43
|
|
Relationship Assessment Scale (RAS)
10 days post-intervention
|
31.41 score on a scale
Standard Deviation 4.45
|
29.24 score on a scale
Standard Deviation 4.97
|
30.82 score on a scale
Standard Deviation 4.62
|
28.93 score on a scale
Standard Deviation 5.75
|
|
Relationship Assessment Scale (RAS)
3 months post-intervention
|
31.49 score on a scale
Standard Deviation 4.42
|
29.27 score on a scale
Standard Deviation 5.39
|
30.72 score on a scale
Standard Deviation 4.97
|
29.16 score on a scale
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluationPopulation: This outcome measure was collected at baseline, 10 days post-program, 3 months post-program, and 6 months post-program for each caregiver active on study at that time point to respond.
The Bakas Caregiving Outcomes Scale (COS), a 15-item with a 7-point scale, self-report inventory, will be utilized to assess family caregiver outcomes. The scale has been used in family caregivers of those with a variety of other chronic conditions (Bakas, Champion, Perkins, Farran, \& Williams, 2006; Pressler, 2008). It is one of recommendation instruments that can be used to identify priority areas for nursing intervention designed to improve caregivers' outcomes (Bakas et al., 2006; Deeken, Taylor, Mangran, Yabroff, \& Ingham, 2003). The 15 Bakas COS items and the validity item are rated on a 7-point scale ranging from -3 (changed for the worst) to + 3 (changed for the best). The -3 to +3 ratings are recoded to 1 to 7, so positive numbers can be obtained for analysis. The COS total scores of range from 15 to 105, with higher score indicating more positive caregiver outcomes. The internal consistency reliability was provided alpha = .90 (Bakas et al., 2006).
Outcome measures
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Daily Engagement Meaningful Activity (DEMA) Caregiver
n=99 Participants
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
Information Support (IS) Caregiver
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|---|---|
|
Caregiving Outcomes Scale (COS)
Baseline
|
57.33 score on a scale
Standard Deviation 8.59
|
59.10 score on a scale
Standard Deviation 9.49
|
—
|
—
|
|
Caregiving Outcomes Scale (COS)
10 days post-intervention
|
58.35 score on a scale
Standard Deviation 7.52
|
58.92 score on a scale
Standard Deviation 7.04
|
—
|
—
|
|
Caregiving Outcomes Scale (COS)
3 months post-intervention
|
59.49 score on a scale
Standard Deviation 8.67
|
59.89 score on a scale
Standard Deviation 10.06
|
—
|
—
|
|
Caregiving Outcomes Scale (COS)
6 months post-intervention
|
58.34 score on a scale
Standard Deviation 7.24
|
57.73 score on a scale
Standard Deviation 7.44
|
—
|
—
|
Adverse Events
Daily Engagement Meaningful Activity (DEMA) Patient
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Information Support (IS) Patient
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Daily Engagement Meaningful Activity (DEMA) Patient
n=100 participants at risk
The DEMA intervention arm received a Self-Management Tool kit in the mail containing educational resources for planning meaningful activities, treatment information for subjective cognitive decline or mild cognitive impairment, emotional management materials for both PwMCI and caregiver, and guidelines to help them access available local and national resources. To tailor the DEMA intervention, interveners receive summary information from the Dementia Deficit Scale on PwMCI and caregiver agreement regarding the PwCI's level of awareness of functional ability and the Canadian Occupational Performance Measure to assess the types and importance of daily meaningful activities and barriers to engaging in these activities. The nurse intervener uses a 5-phase problem-solving principle consists with this intervention's overall goals. The intervener will provide autonomous support by helping the PwCI to identify and prioritize activities, classify needs and goals, generate manageable solutions, engage in self-selected activities with caregiver support, self-evaluate failures and successes, and renew problem-solving skills as needed. Dyads are encouraged to use the DEMA activity log at home, and the intervener will verbally collect data regarding the frequency and duration of activities at each session. The nurse intervener works with the dyads to develop and implement goals related to self-identified meaningful activities chosen by the dyad.
|
Information Support (IS) Patient
n=99 participants at risk
The attention control arm received selected education materials from the Alzheimer's Association, including a pamphlet on MCI. Nurse interveners will employ active listening, open-ended questions, reflecting, and summarizing strategies. The focus of each session will be on: (1) discussing the MCI pamphlet or other general health questions; (2) exploring the experiences of activity engagement and aging; and (3) encouraging dyads to seek additional information from the Alzheimer's Association or their health care provider(s) as needed. No problem-solving strategies or goal-setting strategies will be included. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
2/100 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
1.0%
1/99 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/100 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
0.00%
0/99 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
1.0%
1/99 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/100 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
1.0%
1/99 • Through study completion, up to 9 months
Adverse events could be reported by caregivers during telephone intervention sessions and also were collected for both arms at post-program within 10 days, 3-month post-program, 6-month post-program: emergency department visits, hospitalizations, falls, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place