Tailored Activity Program-Veterans Affairs
Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
1 other identifier
interventional
322
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2018
CompletedResults Posted
Study results publicly available
March 22, 2019
CompletedMarch 22, 2019
December 1, 2018
3.8 years
May 18, 2011
September 13, 2017
December 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.
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
Baseline, 4 month (short-term follow-up), 8 month (long-term)
Secondary Outcomes (1)
12-item Zarit Burden Short Form Measuring Caregiver Burden
Baseline, 4 month (short-term follow-up), 8 month (long-term)
Study Arms (2)
Tailored Activity Program
EXPERIMENTALOccupational 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
ACTIVE COMPARATORCaregivers 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.
Interventions
The interventionist, an occupational therapist, meets with the caregiver and introduces the intervention goals. The OT provides and reviews written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed is The 36 Hour Day. The OT interviews the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT also observes interactions, noting communication and management style. The OT will also meet with the Veteran, observe social capacity using the Peavy Comportment scale and administer the Dementia Rating Scale.
Caregivers in this group received bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers were provided information about dementia and strategies for disease management. Each telephone contact began with a brief overview the session purpose, followed by a description of key facts, and concluded with a question and answer period. The attention control group intervention was delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
Eligibility Criteria
You may qualify if:
- 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)
- +11 more criteria
You may not qualify if:
- Non English speaking
- Non-Veteran
- No caregiver
- No diagnosis of dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
Related Publications (2)
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.
PMID: 24060106BACKGROUNDGitlin 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.
PMID: 29192967RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study limitations include use of a single veteran setting, small sample size, and that medication change effects are unclear.
Results Point of Contact
- Title
- Dr. Paul Arthur
- Organization
- Center of Innovation on Disability and Rehabilitation Research, Department of Veterans Affairs; St. Catherine University, Department of Occupational Therapy
Study Officials
- PRINCIPAL INVESTIGATOR
Ivette Freytes, PhD MS BS
North Florida/South Georgia Veterans Health System, Gainesville, FL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 20, 2011
Study Start
August 1, 2012
Primary Completion
June 1, 2016
Study Completion
December 5, 2018
Last Updated
March 22, 2019
Results First Posted
March 22, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share