Clinical trial NCT01357564: Tailored Activity Program-Veterans Affairs
Official title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
caregivers
tailored activity
neuropsychiatric symptoms
behavioral symptoms
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-20
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.
timeFrame: Baseline, 4 month (short-term follow-up), 8 month (long-term)
Secondary outcomes:
measure: 12-item Zarit Burden Short Form Measuring Caregiver Burden
timeFrame: Baseline, 4 month (short-term follow-up), 8 month (long-term)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Ivette Freytes, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gitlin LN, Mann WC, Vogel WB, Arthur PB. A non-pharmacologic approach to address challenging behaviors of Veterans with dementia: description of the tailored activity program-VA randomized trial. BMC Geriatr. 2013 Sep 23;13:96. doi: 10.1186/1471-2318-13-96.
citation: Gitlin LN, Arthur P, Piersol C, Hessels V, Wu SS, Dai Y, Mann WC. Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial. J Am Geriatr Soc. 2018 Feb;66(2):339-345. doi: 10.1111/jgs.15194. Epub 2017 Nov 28.