Trial Outcomes & Findings for Tailored Activity Program-Veterans Affairs (NCT NCT01357564)

NCT ID: NCT01357564

Last Updated: 2019-03-22

Results Overview

The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia. The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity. The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

322 participants

Primary outcome timeframe

Baseline, 4 month (short-term follow-up), 8 month (long-term)

Results posted on

2019-03-22

Participant Flow

Participant milestones

Participant milestones
Measure
Tailored Activity Program
Intervention Group Tailored Activity Program: Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe interactions, noting communication and management style. The OT will also meet with the Veteran, observe social capacity using the Peavy Comportment scale and administer the Dementia Rating Scale (DRS-2).
Attention Control
Attention Control
Short-term (4-month) Follow up
STARTED
154
168
Short-term (4-month) Follow up
COMPLETED
106
118
Short-term (4-month) Follow up
NOT COMPLETED
48
50
Long-term (8-month) Follow-up
STARTED
106
118
Long-term (8-month) Follow-up
COMPLETED
104
102
Long-term (8-month) Follow-up
NOT COMPLETED
2
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tailored Activity Program-Veterans Affairs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tailored Activity Program
n=154 Participants
Tailored intervention activity. Tailored Activity Program: Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe interactions, noting communication and management style.
Attention Control
n=168 Participants
Attention control. Caregivers in this group receive bi-weekly telephone contact (up to 8 contacts) by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for managing the disease at home (Table 2). Each telephone contact is approximately 30 minutes in length and begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
Total
n=322 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
24 Participants
n=99 Participants
28 Participants
n=107 Participants
52 Participants
n=206 Participants
Age, Categorical
>=65 years
130 Participants
n=99 Participants
140 Participants
n=107 Participants
270 Participants
n=206 Participants
Age, Continuous
77.43 years
n=99 Participants
71.34 years
n=107 Participants
76.21 years
n=206 Participants
Sex: Female, Male
Female
77 Participants
n=99 Participants
84 Participants
n=107 Participants
161 Participants
n=206 Participants
Sex: Female, Male
Male
77 Participants
n=99 Participants
84 Participants
n=107 Participants
161 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=99 Participants
2 Participants
n=107 Participants
6 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
150 Participants
n=99 Participants
165 Participants
n=107 Participants
315 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
20 Participants
n=99 Participants
33 Participants
n=107 Participants
53 Participants
n=206 Participants
Race (NIH/OMB)
White
129 Participants
n=99 Participants
127 Participants
n=107 Participants
256 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=99 Participants
8 Participants
n=107 Participants
13 Participants
n=206 Participants
Region of Enrollment
United States
154 Participants
n=99 Participants
168 Participants
n=107 Participants
322 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 4 month (short-term follow-up), 8 month (long-term)

The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia. The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity. The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure

Outcome measures

Outcome measures
Measure
Tailored Activity Program
n=154 Participants
The INT is designed to draw on residual abilities of Veterans with dementia and provide an environment supportive of these abilities. Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the Veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
Attention Control
n=168 Participants
The ATN Serves 3 purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one-on-one attention to caregivers in the intervention group to rule out potential effects of professional contact; and 3) serves as a retention tool. Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.
T1-T2 (sort term) Change
-38.1 score on a scale
Interval -50.33 to -25.86
1.0 score on a scale
Interval -11.8 to 13.8
The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.
T1-T3 (long term) Change
-12 score on a scale
Interval -23.22 to -0.78
-9.8 score on a scale
Interval -20.19 to 0.58

SECONDARY outcome

Timeframe: Baseline, 4 month (short-term follow-up), 8 month (long-term)

Caregiver burden as measured by the 12-item Zarit Burden Short Form. Scores range from 0-48, with higher scores indicating burden; scores over 17 indicate particularly high levels of caregiver burden. The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure

Outcome measures

Outcome measures
Measure
Tailored Activity Program
n=154 Participants
The INT is designed to draw on residual abilities of Veterans with dementia and provide an environment supportive of these abilities. Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the Veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
Attention Control
n=168 Participants
The ATN Serves 3 purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one-on-one attention to caregivers in the intervention group to rule out potential effects of professional contact; and 3) serves as a retention tool. Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
12-item Zarit Burden Short Form Measuring Caregiver Burden
T1-T2 (short term) change
-1.4 units on a scale
-1.6 units on a scale
12-item Zarit Burden Short Form Measuring Caregiver Burden
T1-T3 (long term) change
-0.7 units on a scale
0.01 units on a scale

Adverse Events

Tailored Activity Program

Serious events: 7 serious events
Other events: 0 other events
Deaths: 5 deaths

Attention Control

Serious events: 4 serious events
Other events: 0 other events
Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure
Tailored Activity Program
n=154 participants at risk
The INT is designed to draw on residual abilities of Veterans with dementia and provide an environment supportive of these abilities. Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the requisite knowledge and skills to use activities. Caregivers are instructed in specific skills such as ways to simplify activities, the environment and their communication, and how to help the Veteran initiate and follow a sequence. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
Attention Control
n=168 participants at risk
The ATN Serves 3 purposes: 1) creates clinical equipoise, ensuring that ethical treatment is provided to all study participants; 2) controls for the one-on-one attention to caregivers in the intervention group to rule out potential effects of professional contact; and 3) serves as a retention tool. Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. Table 2 outlines the specific domain and session content that is covered. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
Congenital, familial and genetic disorders
Hospitalization/Rehab
4.5%
7/154 • Number of events 7
2.4%
4/168 • Number of events 4

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Arthur

Center of Innovation on Disability and Rehabilitation Research, Department of Veterans Affairs; St. Catherine University, Department of Occupational Therapy

Phone: 3176881499

Results disclosure agreements

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