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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116464
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Dementia Family Caregiver Burden and Conflict Behavioral: Telemental Health Family Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family Telemental Health Intervention for Veterans With Dementia
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116464


Contacts
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Contact: Cory K Chen, PhD (212) 686-7500 ext 4002 Cory.Chen@va.gov
Contact: Lauren Wash, MA (212) 686-7500 ext 3003 lauren.wash@va.gov

Locations
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United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Recruiting
New York, New York, United States, 10010
Contact: Cory K Chen, PhD    212-686-7500 ext 4002    Cory.Chen@va.gov   
Principal Investigator: Cory K. Chen, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Cory K. Chen, PhD Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03116464    
Other Study ID Numbers: PPO 16-131
I21HX002256 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders