Over 5 million Americans have Alzheimer's disease or related dementias, a progressive and irreversible neurodegenerative syndrome, with prevalence rates expected to reach close to 16 million individuals by 2050. Among Veterans 65 and older, prevalence rates are similar to the population at-large with 7.3% having dementia across all races, except for African-Americans for whom the rate is 50% higher. A hallmark of dementia is neuropsychiatric symptoms (NPS;e.g., agitation, apathy, aggressiveness). NPS are associated with increased health care costs, and reduced quality of life and daily functioning, heightened family caregiver burden, and nursing home placement. Standard care typically involves pharmacologic agents, but these are at best modestly effective, carry serious risks including mortality, and do not address behavioral symptoms families themselves consider most distressful or that prompt nursing home placement. This study addresses the urgent need to develop and test innovative nonpharmacologic approaches to manage NPS in Veterans with dementia. We propose a Phase III efficacy trial to test a transformative patient-centric intervention, the Tailored Activity Program (TAP) that involves a systematic assessment to identify Veterans'preserved capabilities and deficit areas, and previous roles, habits and interests from which to tailor activities. In up to 8 home sessions over 4 months, the primary family caregiver is trained to incorporate tailored activities into daily care routines. TAP will be tested in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their primary family caregivers will be randomly assigned to TAP or an attention control group and interviewed at baseline, 4 and 8 months to evaluate effect on NPS, caregiver well-being and costs. Our primary study aim concerns the Veteran with dementia and tests the immediate effect of TAP at 4-months on NPS. Our hypothesis is that Veterans with dementia who receive TAP will manifest lower total scores on the Neuropsychiatric Inventory (NPI), which assesses frequency and severity of 12 common neuropsychiatric symptoms, compared to Veterans assigned to an attention control group. We also propose four secondary aims. These are to: 1) Test the long-term effects of TAP at 8-months on quality of life and neuropsychiatric behaviors of Veterans with dementia. Hypothesis: Veterans receiving TAP will manifest higher quality of life and lower total NPI scores over time (baseline to 8- months) in comparison to Veterans in the attention control group;2) Test the immediate effects of TAP at 4-months and long-term effects at 8-months on caregiver burden, skill acquisition, efficacy using activities, and time spent providing care. Hypotheses: Caregivers receiving TAP will report reduced burden, enhanced skills and efficacy using activities, and less time providing care compared to the control group at 4, and 8-months;3) Examine whether caregivers receiving TAP are using activities at 8 months;and 4) Examine whether TAP results in reduced VHA health care use and costs for Veterans with dementia and their caregivers. Results from these secondary aims will provide further evidence of efficacy, identify whether booster sessions are necessary, and inform dissemination efforts and translation of TAP system-wide. Our long-term objective, if proven efficacious, is to integrate TAP into standard care practices within the VHA system as the first treatment choice to address NPS in Veterans with dementia living at home. This would transform the current paradigm of dementia care which relies on pharmacologic management.

Public Health Relevance

This study addresses the urgent need to develop and test innovative nonpharmacologic approaches to manage neuropsychiatric symptoms (NPS) in Veterans with dementia. We propose a Phase III efficacy trial to test a transformative patient-centric intervention, Tailored Activity Program (TAP). It involves a systematic assessment to identify Veterans'preserved capabilities, deficit areas, previous roles, habits and interests from which to tailor activities. In 8 home sessions over 4 months, primary family caregivers are trained to incorporate activities tailored to Veterans'profiles into care routines. TAP will be tested in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their primary caregivers will be randomly assigned to TAP or attention control and interviewed at baseline, 4, and 8 months to evaluate effect on NPS, caregiver well-being and costs.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
1I01HX000735-01
Application #
8204150
Study Section
Blank (HSR6)
Project Start
2011-12-01
Project End
2015-11-30
Budget Start
2011-12-01
Budget End
2012-11-30
Support Year
1
Fiscal Year
2013
Total Cost
Indirect Cost
Name
Veterans Health Administration
Department
Type
DUNS #
097378632
City
Gainesville
State
FL
Country
United States
Zip Code
32608