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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01357564
The ClinicalTrials.gov registry entry for NCT01357564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Attention Control is the first listed.
NCT01357564 reports 0 study locations.
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.
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