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Tailored Activity Program-VA

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01357564
First received: May 18, 2011
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This proposed study addresses this call by testing 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. We plan to test TAP-VA in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their family caregivers (dyads) will be randomly assigned to receive TAP-VA or an attention control group. All dyads will be 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.


Condition Intervention Phase
Dementia
Other: Tailored Activity Program
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome for the proposed trial is symptom reduction of neuropsychiatric behaviors (NPI total frequency by severity score) [ Time Frame: Year 1 through second quarter of Year 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Comparison of attention control versus customized intervention activity.
Other: Tailored Activity Program
Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe 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 (DRS-2).

Detailed Description:

This proposed study addresses this call by testing 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. We plan to test TAP-VA in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their family caregivers (dyads) will be randomly assigned to receive TAP-VA or an attention control group. All dyads will be 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357564

Contacts
Contact: William C Mann, PhD MS BS (352) 376-1611 ext 4942 William.Mann@va.gov
Contact: Virginia L Hessels, BA (352) 376-1611 ext 4920 virginia.hessels@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Contact: William C Mann, PhD MS BS    352-376-1611 ext 4942    William.Mann@va.gov   
Principal Investigator: William C. Mann, PhD MS BS         
Sponsors and Collaborators
Investigators
Principal Investigator: William C. Mann, PhD MS BS North Florida/South Georgia Veterans Health System
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01357564     History of Changes
Other Study ID Numbers: IIR 11-119
Study First Received: May 18, 2011
Last Updated: June 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
dementia
caregivers
tailored activity

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014