Clinical trial NCT03116464: Family Telemental Health Intervention for Veterans With Dementia
Official title: Family Telemental Health Intervention for Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia Family Caregiver Burden and Conflict
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Family based telemental health intervention that incorporates: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Healthy Aging Brain Center Monitor (HABC Monitor):
timeFrame: Post Treatment, an average of 12-18 weeks
Secondary outcomes:
measure: The Kansas Marital Conflict Scale (KMCS)
timeFrame: Post Treatment, an average of 12-18 weeks
measure: Patient Health Questionnaire - 9 (PHQ)
timeFrame: Post Treatment, an average of 12-18 weeks
measure: Zarit Burden Scale
timeFrame: Post Treatment, an average of 12-18 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Cory K. Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: