Tailored Activity Program-Veterans Affairs



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:August 2012
End Date:December 5, 2018

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Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia

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.

This study tests the efficacy of a transformative patient-centric intervention designed to
reduce the burden of NPS in Veterans with dementia who live at home with family caregivers.
The innovative intervention, the Tailored Activity Program (TAP-VA), involves 8 sessions over
4 months in Veterans' homes. An occupational therapist conducts a systematic assessment to
identify a Veteran's preserved capabilities and deficit areas, and previous roles, habits and
interests from which to develop and introduce activities tailored to the Veteran's profile.
Family caregivers are then trained to incorporate tailored activities into daily care
routines. The intervention was pilot tested in an NIMH funded study with 60 community-living
individuals with dementia. Findings from this pilot showed statistically significant and
clinically meaningful reductions in NPS, specifically agitation and less time being on "duty"
by family caregivers. Results of this pilot phase support moving forward with a full-scale
Phase III efficacy trial. The investigators tested TAP-VA in a randomized two-group parallel
design in which 160 racially and ethnically diverse Veterans with dementia and their family
caregivers (dyads) were randomly assigned to receive TAP-VA or an attention control group.
All dyads were evaluated at baseline and 4-months (main trial endpoint), and then reassessed
at 8-months to evaluate long-term treatment effects (baseline to 8 months), including
continued activity use, caregiver well-being, and costs.

Inclusion Criteria:

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

- not currently participating in any other caregiver-related intervention.

- Finally, we will require that caregivers taking a psychotropic medication
(antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) at time of
telephone screen be on a stable dose of the medication for 60 days prior to
enrollment.

Exclusion Criteria:

- Non English speaking

- Non-Veteran

- No caregiver

- No diagnosis of dementia
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