Tailored Activity Program-Veterans Affairs

Completed · Not applicable

Conditions studied: Dementia

In brief

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.

Key facts

Study ID

NCT01357564

Run by

VA Office of Research and Development

People needed

322

Starts

2012-08-01

Expected to finish

2018-12-05

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for Veterans with dementia include:
• English speaking
• diagnosed with dementia as above
• able to participate in at least two activities of daily living
• ADLs - bathing
• dressing
• grooming
• toileting
• transferring from bed to chair
• not currently participating in any other dementia-related intervention.
• If the Veteran with dementia is on any of four classes of psychotropic medications:
• antidepressant
• benzodiazepines
• antipsychotic
• anti-convulsant
• an anti-dementia medication (memantine or a cholinesterase inhibitor)
• We will require that he/she have been on a stable dose for 60 days prior to enrollment to minimize possible confounding effects of concomitant medications (the typical time frame used in clinical trials).
• Caregivers of Veterans must be:
• English speaking
• self-identify as the primary member of the family caring (hands-on or supervision) for the Veteran and 21 years of age or older (male or female)
• living with the Veteran
• accessible by telephone to schedule interview, intervention sessions and follow-up interviews
• planning to live in area for 8 months (to reduce loss to follow-up)
• indicate willingness to learn activity use
• report one or more NPS in the Veteran in the past month

You may not qualify if…

• Non English speaking
• Non-Veteran
• No caregiver
• No diagnosis of dementia

Where it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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