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NCT01357564 · ClinicalTrials.gov registry record · NA
Tailored Activity Program-Veterans Affairs
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 322
- Enrollment target
NCT01357564: Completed NA study, sponsored by VA Office of Research and Development.
NCT01357564 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 322 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357564, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 322 participants
- Enrollment target
Study Summary
The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.
Primary Outcome
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
Interventions
- OTHER Attention Control
- OTHER Tailored Activity Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2012-08 |
| Est. Completion | 2018-12-05 |
| Phase | NA |
What the finished NCT01357564 record still lists
NCT01357564 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Attention Control is the first listed.
NCT01357564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01357564 about?
NCT01357564 is a clinical study titled "Tailored Activity Program-Veterans Affairs". The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The ex...
What is the current status of trial NCT01357564?
This trial is currently completed. It is a NA study. The enrollment target is 322 participants. The study started on 2012-08. Estimated completion is 2018-12-05.
What interventions are being tested in trial NCT01357564?
The interventions under investigation include: Attention Control (OTHER), Tailored Activity Program (OTHER).
Who is sponsoring clinical trial NCT01357564?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01357564's enrollment target sits among peer trials
322 315th of 2000 higher than 1,686 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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