Trial Outcomes & Findings for Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA (NCT NCT04627662)

NCT ID: NCT04627662

Last Updated: 2026-03-20

Results Overview

The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

375 participants

Primary outcome timeframe

Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Results posted on

2026-03-20

Participant Flow

Care Partners were remotely recruited from across the United States from clinics, electronic medical record systems, ADRC research cohorts, ResearchMatch and other national registries (e.g., RISE), community advisory committees, faith communities, and the community at large. We used social media (e.g., Facebook, Instagram) advertisements to recruit Care Partners from the ADRC regions.

Care Recipients were consented and enrolled into the study to collect demographic data about them. Care Recipients did not participate in the interventions, but because the virtual interventions were videorecorded, there may have been a time where the Care Recipient inadvertently steps into view of the camera and have their likeness recorded. In the case that happens, we had their consent to be videorecorded.

Participant milestones

Participant milestones
Measure
Care Partners
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Care Recipients
Family member with dementia who has a diagnosis of ADRD in the moderate to late stages as defined by the family member and exhibits two or more behaviors that the Care Partner reports as extremely upsetting and occurring more than once per week.
Overall Study
STARTED
188
187
Overall Study
Nova: one-to-one (4 weeks)
177
0
Overall Study
Nova: small groups (4 weeks)
162
0
Overall Study
Constellation (8 weeks)
127
0
Overall Study
COMPLETED
105
105
Overall Study
NOT COMPLETED
83
82

Reasons for withdrawal

Reasons for withdrawal
Measure
Care Partners
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Care Recipients
Family member with dementia who has a diagnosis of ADRD in the moderate to late stages as defined by the family member and exhibits two or more behaviors that the Care Partner reports as extremely upsetting and occurring more than once per week.
Overall Study
Adverse Event
2
2
Overall Study
Not a good fit
12
12
Overall Study
Overwhelmed/Too busy
13
13
Overall Study
Personal reasons
10
9
Overall Study
PwD death
21
21
Overall Study
PwD in hospice
3
3
Overall Study
Lost to Follow-up
3
3
Overall Study
Protocol Violation
19
19

Baseline Characteristics

Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Care Recipients
n=187 Participants
Family member with dementia who has a diagnosis of ADRD in the moderate to late stages as defined by the family member and exhibits two or more behaviors that the Care Partner reports as extremely upsetting and occurring more than once per week.
Total
n=375 Participants
Total of all reporting groups
Age, Continuous
63.80 years
STANDARD_DEVIATION 11.87 • n=154 Participants
77.86 years
STANDARD_DEVIATION 9.41 • n=151 Participants
70.83 years
STANDARD_DEVIATION 12.80 • n=305 Participants
Sex/Gender, Customized
Female
138 Participants
n=154 Participants
106 Participants
n=151 Participants
244 Participants
n=305 Participants
Sex/Gender, Customized
Male
48 Participants
n=154 Participants
81 Participants
n=151 Participants
129 Participants
n=305 Participants
Sex/Gender, Customized
Other
2 Participants
n=154 Participants
0 Participants
n=151 Participants
2 Participants
n=305 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=154 Participants
11 Participants
n=151 Participants
21 Participants
n=305 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
178 Participants
n=154 Participants
176 Participants
n=151 Participants
354 Participants
n=305 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=154 Participants
0 Participants
n=151 Participants
0 Participants
n=305 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=154 Participants
1 Participants
n=151 Participants
1 Participants
n=305 Participants
Race (NIH/OMB)
Asian
4 Participants
n=154 Participants
4 Participants
n=151 Participants
8 Participants
n=305 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=154 Participants
1 Participants
n=151 Participants
3 Participants
n=305 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=154 Participants
15 Participants
n=151 Participants
29 Participants
n=305 Participants
Race (NIH/OMB)
White
161 Participants
n=154 Participants
162 Participants
n=151 Participants
323 Participants
n=305 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=154 Participants
4 Participants
n=151 Participants
11 Participants
n=305 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=154 Participants
0 Participants
n=151 Participants
0 Participants
n=305 Participants

PRIMARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Pre-Intervention (Nova)
40.7 score on a scale
Standard Deviation 15.3
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Post-Intervention (Nova)
35.6 score on a scale
Standard Deviation 16.5
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
One Month Follow-Up (Nova)
35.7 score on a scale
Standard Deviation 16.4
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Pre-Intervention (Constellation)
35.0 score on a scale
Standard Deviation 16.6
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Post-Intervention (Constellation)
33.2 score on a scale
Standard Deviation 16.4
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Two Month Follow-Up (Constellation)
33.0 score on a scale
Standard Deviation 16.3
Revised Memory and Behavior Problems Checklist, Reactivity Subscale
Overall
36.1 score on a scale
Standard Deviation 16.4

PRIMARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Pre-Intervention (Nova)
43.7 score on a scale
Standard Deviation 13.6
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Post-Intervention (Nova)
39.9 score on a scale
Standard Deviation 12.0
Revised Memory and Behavior Problems Checklist, Frequency Subscale
One Month Follow-Up (Nova)
39.7 score on a scale
Standard Deviation 12.9
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Pre-Intervention (Constellation)
39.2 score on a scale
Standard Deviation 13.8
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Post-Intervention (Constellation)
40.2 score on a scale
Standard Deviation 14.7
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Two Month Follow-Up (Constellation)
40.3 score on a scale
Standard Deviation 12.1
Revised Memory and Behavior Problems Checklist, Frequency Subscale
Overall
40.7 score on a scale
Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

Marwit-Meuser Caregiver Grief Index-Short Form (MM-CGI) is an 18-item caregiver-report measure of pre-death grief. Items are on a 5-point Likert scale and summed for a total score ranging between 18 to 90. Higher scores on this measure indicate greater caregiver grief.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Marwit Meuser Caregiver Grief Index-Short Form
Pre-Intervention (Nova)
57.8 score on a scale
Standard Deviation 12.4
Marwit Meuser Caregiver Grief Index-Short Form
Post-Intervention (Nova)
57.4 score on a scale
Standard Deviation 13.0
Marwit Meuser Caregiver Grief Index-Short Form
One Month Follow-Up (Nova)
57.4 score on a scale
Standard Deviation 12.8
Marwit Meuser Caregiver Grief Index-Short Form
Pre-Intervention (Constellation)
55.8 score on a scale
Standard Deviation 12.3
Marwit Meuser Caregiver Grief Index-Short Form
Post-Intervention (Constellation)
56.2 score on a scale
Standard Deviation 12.4
Marwit Meuser Caregiver Grief Index-Short Form
Two-Month Follow-Up (Constellation)
55.3 score on a scale
Standard Deviation 12.0
Marwit Meuser Caregiver Grief Index-Short Form
Overall
56.8 score on a scale
Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

The Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner version includes 13 items on a 4-point Likert scale with answers ranging from 1 = poor to 4 = excellent. The total score is the sum of items with a score range between 13-52. Higher scores indicate a better perceived quality of life for the care partner.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Pre-Intervention (Nova)
34.7 score on a scale
Standard Deviation 6.07
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Post-Intervention (Nova)
35.1 score on a scale
Standard Deviation 6.09
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Post-Intervention (Constellation)
35.7 score on a scale
Standard Deviation 6.16
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
One Month Follow-Up (Nova)
34.9 score on a scale
Standard Deviation 6.25
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Pre-Intervention (Constellation)
35.0 score on a scale
Standard Deviation 6.38
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Two Month Follow-Up (Constellation)
35.6 score on a scale
Standard Deviation 5.66
Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner
Overall
35.1 score on a scale
Standard Deviation 6.11

SECONDARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

The 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10) is a self-report measure of depressive symptoms on a 4-point Likert scale with answers ranging from 0-3 (0 = rarely/none to 3 = most/all of the time). Items are summed after reverse scoring for the two positively worded items with a total score range of 0-30. Higher scores indicate greater depressive symptoms.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Pre-Intervention (Nova)
11.9 score on a scale
Standard Deviation 6.16
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Post-Intervention (Nova)
10.9 score on a scale
Standard Deviation 6.07
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
One Month Follow-Up (Nova)
11.3 score on a scale
Standard Deviation 6.13
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Pre-Intervention (Constellation)
11.1 score on a scale
Standard Deviation 6.27
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Post-Intervention (Constellation)
10.6 score on a scale
Standard Deviation 6.37
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Two Month Follow-Up (Constellation)
10.2 score on a scale
Standard Deviation 6.09
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)
Overall
11.1 score on a scale
Standard Deviation 6.18

SECONDARY outcome

Timeframe: Baseline (first weekly survey at study enrollment, prior to intervention).

Zarit Burden Intervention 4-item (ZBI-4) is a 4-item caregiver-report measure of perceived burden. Items were on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). The total score was the sum of items with a range of 0-16. Higher scores indicated greater caregiver burden.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
4-item Zarit Burden Interview (ZBI-4)
9.41 units on a scale
Standard Deviation 2.83

SECONDARY outcome

Timeframe: Baseline (1 week prior to Constellation intervention start)

The Ten Item Personality Inventory (TIPI) is a 10-item Likert scale measure of the Big Five personality traits. Choices range from 1(disagree strongly) to 7 (agree strongly) with reverse scoring on items 2, 4, 6, 8 and 10. Scoring included the average of the two items as follows: extraversion: 1, 6R; agreeableness: 2R, 7; conscientiousness: 3, 8R; emotional stability: 4R, 9; openness to experiences: 5, 10R. Each trait had a score range of 1-7 with higher scores indicating greater standing on each trait dimension.

Outcome measures

Outcome measures
Measure
Care Partners
n=119 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Ten Item Personality Inventory (TIPI)
Extraverted, enthusiastic
4.50 score on a scale
Standard Deviation 1.89
Ten Item Personality Inventory (TIPI)
Critical, quarrelsome
5.30 score on a scale
Standard Deviation 1.54
Ten Item Personality Inventory (TIPI)
Dependable, self-disciplined
6.12 score on a scale
Standard Deviation 1.04
Ten Item Personality Inventory (TIPI)
Anxious, easily upset
4.43 score on a scale
Standard Deviation 1.86
Ten Item Personality Inventory (TIPI)
Openness to new experiences, complex
5.78 score on a scale
Standard Deviation 1.08
Ten Item Personality Inventory (TIPI)
Reserved, quiet
4.03 score on a scale
Standard Deviation 1.84
Ten Item Personality Inventory (TIPI)
Sympathetic, warm
5.94 score on a scale
Standard Deviation 1.15
Ten Item Personality Inventory (TIPI)
Disorganized, careless
5.36 score on a scale
Standard Deviation 1.70
Ten Item Personality Inventory (TIPI)
Calm, emotionally stable
5.09 score on a scale
Standard Deviation 1.42
Ten Item Personality Inventory (TIPI)
Conventional, uncreative
5.15 score on a scale
Standard Deviation 1.60

SECONDARY outcome

Timeframe: Baseline (at study enrollment) and post-Constellation (8 weeks after Constellation start)

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame.

Investigator-developed single-item measure of computer self-efficacy: "I am confident in my ability to use computers." Care partners rated this sentence from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater perceived computer self-efficacy.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Computer Self-Efficacy and Computer Anxiety Survey
Strongly disagree (pre-intervention)
0 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Strongly disagree (post-intervention)
3 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Disagree (pre-intervention)
6 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Disagree (post-intervention)
4 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Neutral (pre-intervention)
36 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Neutral (post-intervention)
6 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Agree (pre-intervention)
71 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Agree (post-intervention)
22 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Strongly agree (pre-intervention)
75 Participants
Computer Self-Efficacy and Computer Anxiety Survey
Strongly agree (post-intervention)
62 Participants

SECONDARY outcome

Timeframe: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Population: Due to participants withdrawing during the study or not completing the surveys, analyses were conducted on different amounts of participants per time frame. Pre-Intervention (Nova), N=177; Post-Intervention (Nova), N=151; One Month Follow-Up (Nova), N=146; Pre-Intervention (Constellation), N=119; Post-Intervention (Constellation), N=106; Two Month Follow-Up, N=100.

The Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient version includes 13 items on a 4-point Likert scale with answers ranging from 1 = poor to 4 = excellent. Care partners reported on this based on how they think their care recipient would respond. The total score is the sum of items with a score range between 13-52. Higher scores indicate a better perceived quality of life for the care recipient.

Outcome measures

Outcome measures
Measure
Care Partners
n=188 Participants
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Pre-Intervention (Constellation)
30.1 score on a scale
Standard Deviation 7.56
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Pre-Intervention (Nova)
29.9 score on a scale
Standard Deviation 7.01
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Post-Intervention (Nova)
29.8 score on a scale
Standard Deviation 7.17
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
One Month Follow-Up (Nova)
29.6 score on a scale
Standard Deviation 7.24
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Post-Intervention (Constellation)
30.7 score on a scale
Standard Deviation 7.32
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Two Month Follow-Up (Constellation)
29.9 score on a scale
Standard Deviation 7.45
Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient
Overall
30.0 score on a scale
Standard Deviation 7.25

Adverse Events

Care Partners

Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths

Care Recipients

Serious events: 25 serious events
Other events: 65 other events
Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure
Care Partners
n=188 participants at risk
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Care Recipients
n=187 participants at risk
Family member with dementia who has a diagnosis of ADRD in the moderate to late stages as defined by the family member and exhibits two or more behaviors that the Care Partner reports as extremely upsetting and occurring more than once per week.
General disorders
Hospitalization
1.6%
3/188 • Number of events 3 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
11.2%
21/187 • Number of events 25 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Life Threatening
0.00%
0/188 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
0.53%
1/187 • Number of events 1 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Urgent Care
0.00%
0/188 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
0.53%
1/187 • Number of events 1 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Other
1.1%
2/188 • Number of events 2 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
1.1%
2/187 • Number of events 2 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.

Other adverse events

Other adverse events
Measure
Care Partners
n=188 participants at risk
Family caregivers of persons with dementia that care for their family member for more than 4 hours per week and report at least two behaviors their family member does that are extremely upsetting and occur more than once per week.
Care Recipients
n=187 participants at risk
Family member with dementia who has a diagnosis of ADRD in the moderate to late stages as defined by the family member and exhibits two or more behaviors that the Care Partner reports as extremely upsetting and occurring more than once per week.
General disorders
Hospice
0.00%
0/188 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
2.7%
5/187 • Number of events 5 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Hospitalization
2.7%
5/188 • Number of events 5 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
9.1%
17/187 • Number of events 22 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Urgent Care
1.6%
3/188 • Number of events 4 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
16.0%
30/187 • Number of events 37 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
COVID
2.1%
4/188 • Number of events 4 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
3.2%
6/187 • Number of events 7 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Falls
0.53%
1/188 • Number of events 1 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
4.3%
8/187 • Number of events 9 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
General disorders
Other
11.2%
21/188 • Number of events 25 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.
8.0%
15/187 • Number of events 20 • Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected.

Additional Information

Dr. Allison Lindauer

Oregon Health & Science University

Phone: (503) 494-6976

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place