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Clinical Trials/NCT03116464
NCT03116464
Terminated
Not Applicable

Family Telemental Health Intervention for Veterans With Dementia

VA Office of Research and Development1 site in 1 country4 target enrollmentSeptember 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia Family Caregiver Burden and Conflict
Sponsor
VA Office of Research and Development
Enrollment
4
Locations
1
Primary Endpoint
Healthy Aging Brain Center Monitor (HABC Monitor):
Status
Terminated
Last Updated
10 months ago

Overview

Brief Summary

Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.

Detailed Description

Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
December 30, 2022
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Either the caregiver or the care-recipient must be a Veteran.
  • The caregiver must:
  • Be the primary unpaid family or friend who helps or supports an individual with dementia
  • Be involved in the care of the person with dementia (at least 4 hours of care per day)
  • Report that the care-recipient exhibits behavioral problems that are distressing
  • Not be currently receiving the REACH VA protocol
  • Additionally, the care-recipient must:
  • Must have a documented diagnosis of dementia
  • Have cognitive impairment (MMSE\<23 or SLUMS\<20 or diagnosis of dementia based on chart review)
  • Be out of bed and able to respond to a caregiver's instructions or interventions

Exclusion Criteria

  • Caregiver severe cognitive impairment
  • Caregiver inability to meet study demands
  • Caregiver psychosis

Outcomes

Primary Outcomes

Healthy Aging Brain Center Monitor (HABC Monitor):

Time Frame: Post Treatment, an average of 12-18 weeks

A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity.

Secondary Outcomes

  • Zarit Burden Scale(Post Treatment, an average of 12-18 weeks)
  • Patient Health Questionnaire - 9 (PHQ)(Post Treatment, an average of 12-18 weeks)
  • The Kansas Marital Conflict Scale (KMCS)(Post Treatment, an average of 12-18 weeks)

Study Sites (1)

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