Family Telemental Health Intervention for Veterans With Dementia (TMH Pilot)

February 8, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010-5011
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
Caregiver and patient with dementia dyads who receive the family intervention.
Behavioral: Telemental Health Family Intervention
Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post Treatment, an average of 12-18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Kansas Marital Conflict Scale (KMCS)
Time Frame: Post Treatment, an average of 12-18 weeks
A 37-item self-report scale consisting of three subscales of how well partners are able to: (1) listen and understand each other's perspectives, (2) express his or her point of view , and (3) come to a mutually satisfactory compromise. It has been shown to have high internal consistency ( = .87 to .90) and test-retest reliability (r = .62 to .92). Although developed for marital relationships, all items are applicable or easily modified for a variety of interpersonal relationships.
Post Treatment, an average of 12-18 weeks
Patient Health Questionnaire - 9 (PHQ)
Time Frame: Post Treatment, an average of 12-18 weeks
A 9-item self-report scale based on DSM-IV criteria for Major Depressive Disorder, has been shown to have good sensitivity and specificity and is predictive of health outcomes such as sick days, clinic visits, and symptom related difficulty. Internal reliability of the PHQ-9 is excellent ( = 0.89).
Post Treatment, an average of 12-18 weeks
Zarit Burden Scale
Time Frame: Post Treatment, an average of 12-18 weeks
A 12-item self-report scale shown to have acceptable indices of internal consistency for the two distinct factors of the scale - personal strain and role strain ( =0.88 and =0.78) and a good predictor of caregiver mental health outcomes.
Post Treatment, an average of 12-18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Cory K. Chen, PhD, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2017

Primary Completion (ACTUAL)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (ACTUAL)

April 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPO 16-131
  • I21HX002256 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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