Overview

This trial is active, not recruiting.

Condition dementia
Treatment tailored activity program
Phase phase 1
Sponsor VA Office of Research and Development
Start date August 2012
End date November 2015
Trial size 160 participants
Trial identifier NCT01357564, IIR 11-119

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Other)
Comparison of attention control versus customized intervention activity.
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).

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
Principal investigator William C. Mann, PhD MS BS
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.