Tailored Activity Program-Veterans Affairs

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Tailored Activity Program; Other: Attention Control

• Registration Number: NCT01357564
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-20
• Study Start: 2012-08
• Primary Completion: 2016-06
• Results First Submitted: 2017-09-13
• Status Verified: 2018-12
• Study Completion: 2018-12-05
• Results First Submitted QC: 2018-12-13
• Last Update Submitted: 2018-12-13
• Results First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Activity Program	Tailored Activity Program	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 knowledge and skills to use activities. 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.
Attention Control	Attention Control	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. 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.

Primary Outcome Measures

Name	Time	Method
The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.	Baseline, 4 month (short-term follow-up), 8 month (long-term)	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

Secondary Outcome Measures

Name	Time	Method
12-item Zarit Burden Short Form Measuring Caregiver Burden	Baseline, 4 month (short-term follow-up), 8 month (long-term)	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

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL; 🇺🇸 Gainesville, Florida, United States