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Tailored Activity Program-VA

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ClinicalTrials.gov Identifier: NCT01357564
Recruitment Status : Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

May 18, 2011
May 20, 2011
January 6, 2017
August 2012
June 2016   (Final data collection date for primary outcome measure)
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 ]
Data analysis is currently underway ( the primary outcome for the proposed trial is symptom reduction of neuropsychiatric behaviors (NPI total frequency by severity score)) and should be available mid 2017.
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 ]
Complete list of historical versions of study NCT01357564 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tailored Activity Program-VA
Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
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. The investigators 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.
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. The investigators 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Dementia
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).
Arm 1
Comparison of attention control versus customized intervention activity.
Intervention: Other: Tailored Activity Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
Same as current
August 2018
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01357564
IIR 11-119
Yes
Not Provided
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: William C. Mann, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL
VA Office of Research and Development
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP