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

Primary Purpose

Dementia Family Caregiver Burden and Conflict

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemental Health Family Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia Family Caregiver Burden and Conflict

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Caregiver and patient with dementia dyads who receive the family intervention.

Outcomes

Primary Outcome Measures

Healthy Aging Brain Center Monitor (HABC Monitor):
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 Outcome Measures

The Kansas Marital Conflict Scale (KMCS)
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.
Patient Health Questionnaire - 9 (PHQ)
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).
Zarit Burden Scale
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.

Full Information

First Posted
April 12, 2017
Last Updated
February 8, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03116464
Brief Title
Family Telemental Health Intervention for Veterans With Dementia
Acronym
TMH Pilot
Official Title
Family Telemental Health Intervention for Veterans With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Family Caregiver Burden and Conflict

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Caregiver and patient with dementia dyads who receive the family intervention.
Intervention Type
Behavioral
Intervention Name(s)
Telemental Health Family Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Healthy Aging Brain Center Monitor (HABC Monitor):
Description
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.
Time Frame
Post Treatment, an average of 12-18 weeks
Secondary Outcome Measure Information:
Title
The Kansas Marital Conflict Scale (KMCS)
Description
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.
Time Frame
Post Treatment, an average of 12-18 weeks
Title
Patient Health Questionnaire - 9 (PHQ)
Description
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).
Time Frame
Post Treatment, an average of 12-18 weeks
Title
Zarit Burden Scale
Description
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.
Time Frame
Post Treatment, an average of 12-18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cory K. Chen, PhD
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010-5011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Family Telemental Health Intervention for Veterans With Dementia

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