Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 5438 for:    veterans

Tailored Activity Program-Veterans Affairs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01357564
Recruitment Status : Completed
First Posted : May 20, 2011
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Dementia
Interventions Other: Tailored Activity Program
Other: Attention Control
Enrollment 322
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tailored Activity Program Attention Control
Hide Arm/Group Description

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
Period Title: Short-term (4-month) Follow up
Started 154 168
Completed 106 118
Not Completed 48 50
Period Title: Long-term (8-month) Follow-up
Started 106 118
Completed 104 102
Not Completed 2 16
Arm/Group Title Tailored Activity Program Attention Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 154 168 322
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 168 participants 322 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  15.6%
28
  16.7%
52
  16.1%
>=65 years
130
  84.4%
140
  83.3%
270
  83.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 154 participants 168 participants 322 participants
77.43
(33 to 100)
71.34
(47 to 91)
76.21
(33 to 100)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 168 participants 322 participants
Female
77
  50.0%
84
  50.0%
161
  50.0%
Male
77
  50.0%
84
  50.0%
161
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 168 participants 322 participants
Hispanic or Latino
4
   2.6%
2
   1.2%
6
   1.9%
Not Hispanic or Latino
150
  97.4%
165
  98.2%
315
  97.8%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 168 participants 322 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  13.0%
33
  19.6%
53
  16.5%
White
129
  83.8%
127
  75.6%
256
  79.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   3.2%
8
   4.8%
13
   4.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 154 participants 168 participants 322 participants
154
 100.0%
168
 100.0%
322
 100.0%
1.Primary Outcome
Title The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.
Hide Description

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

Time Frame Baseline, 4 month (short-term follow-up), 8 month (long-term)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tailored Activity Program Attention Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 154 168
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
T1-T2 (sort term) Change
-38.1
(-50.33 to -25.86)
1.0
(-11.8 to 13.8)
T1-T3 (long term) Change
-12
(-23.22 to -0.78)
-9.8
(-20.19 to .58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Activity Program, Attention Control
Comments Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.72
Confidence Interval (2-Sided) 95%
-1.23 to -0.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 12-item Zarit Burden Short Form Measuring Caregiver Burden
Hide Description

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

Time Frame Baseline, 4 month (short-term follow-up), 8 month (long-term)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tailored Activity Intervention Attention Control
Hide Arm/Group Description:
Tailored Activity Program: Intervention
Phone calls/education
Overall Number of Participants Analyzed 154 168
Measure Type: Number
Unit of Measure: units on a scale
T1-T2 (short term) change -1.4 -1.6
T1-T3 (long term) change -0.7 0.01
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tailored Activity Intervention, Attention Control
Comments Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.1
Confidence Interval (2-Sided) 95%
-0.14 to -0.01
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tailored Activity Program Attention Control
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Tailored Activity Program Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   5/154 (3.25%)      9/168 (5.36%)    
Show Serious Adverse Events Hide Serious Adverse Events
Tailored Activity Program Attention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/154 (4.55%)      4/168 (2.38%)    
Congenital, familial and genetic disorders     
Hospitalization/Rehab *  7/154 (4.55%)  7 4/168 (2.38%)  4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tailored Activity Program Attention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/154 (0.00%)      0/168 (0.00%)    
Study limitations include use of a single veteran setting, small sample size, and that medication change effects are unclear.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paul Arthur
Organization: Center of Innovation on Disability and Rehabilitation Research, Department of Veterans Affairs; St. Catherine University, Department of Occupational Therapy
Phone: 3176881499
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01357564     History of Changes
Other Study ID Numbers: IIR 11-119
First Submitted: May 18, 2011
First Posted: May 20, 2011
Results First Submitted: September 13, 2017
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019