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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Other: Tailored Activity Program Phase 1

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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
Study Start Date : August 2012
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357564


Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: William C. Mann, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL
More Information
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Additional Information:
Alzheimer's information site  This link exits the ClinicalTrials.gov site

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01357564     History of Changes
Other Study ID Numbers: IIR 11-119
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
dementia
caregivers
tailored activity

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders