Family Telemental Health Intervention for Veterans With Dementia

ID: NCT03116464
Status: Recruiting
Phase: N/A
Start Date: September 18, 2017
First Submitted: April 12, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Dementia Family Caregiver Burden and Conflict
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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

Background:

The increase in prevalence of dementia over the last 50 years has resulted in a concomitant rise in the number of families facing the physical, emotional, and psychological stress associated with caregiving. Behavioral symptoms that occur in persons with dementia (PWD) lead to negative mental and physical health outcomes for caregivers and predict caregiver decisions to institutionalize PWD. Resources to Enhance Alzheimer's Caregiver Health - VA (REACH VA), has demonstrated its ability to improve caregiver burden, emotional and physical well-being, social support and management of behavioral symptoms. Although REACH VA represents one of the best available approaches to help caregivers, treatment non-response and modest treatment effects remain significant issues. A variety of factors may be associated with non-response to behavioral intervention - one particularly robust predictor of non-response is interpersonal skill and communication.

Objectives:

The goal of this research project is the first step toward systematically identifying and addressing caregiver interpersonal challenges using telehealth technology. This project involves three interrelated activities: (1) refinement and pilot testing of a video based observational coding manual (OCM) to evaluate interpersonal skills of family caregivers interacting with PWD (2) development of a treatment manual integrally linked to the OCM and (3) assessment of the feasibility of delivering the treatment.

Methods:

1. We will convene an Expert Advisory Panel (EAP) with expertise in interpersonal and family caregiving processes and family psychotherapy to provide feedback on the OCM. The OCM represents an adaptation of previously established and reliable coding manuals developed for assessing interaction patterns in couples, families, and dementia caregiver research. Using an iterative process of refinement based on EAP feedback, pilot coding of video from five initial dyads, and feedback from those dyads we will use coding schemes originally developed for research and adapt them for clinical use. We will then recruit 15 additional dyads and videotape their interactions. Five Psychology Trainees will be trained on the OCM. The PI and pairs of Psychology Trainees will independently code each video to assess validity, reliability, and analyze qualitative data from semi-structured interviews of caregivers, care-recipients, and clinicians to assess acceptability and utility of the OCM.

2. We will draft a treatment manual for a family intervention informed by established empirically supported interventions for couples and families. The treatment manual will target the identified interpersonal skills deficits in the OCM. A draft of the Treatment Manual will be presented to the EAP, eliciting feedback for further refinement. We will pilot test the family intervention via telehealth with the dyads who received the OCM and treatment.

3. We will assess for feasibility of delivery, and dyad benefit from dyad and therapist report, and descriptive analyses of changes in interpersonal conflict, caregiver depression, anxiety, and burden.

Status:

The project team is convening the EAP and implementing the telehealth logistics necessary to begin recording Wave 1 of dyads.
Condition or disease Intervention/treatment Phase

Dementia Family Caregiver Burden and Conflict

Behavioral: Telemental Health Family Intervention
Other Names
N/A

Tracking Information

First Submitted DateApril 12, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateSeptember 18, 2017
Anticipated Completion DateApril 15, 2019
Actual Primary Completion DateApril 16, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

  • 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).

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleFamily Telemental Health Intervention for Veterans With Dementia
Official TitleFamily Telemental Health Intervention for Veterans With Dementia
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

Background:

The increase in prevalence of dementia over the last 50 years has resulted in a concomitant rise in the number of families facing the physical, emotional, and psychological stress associated with caregiving. Behavioral symptoms that occur in persons with dementia (PWD) lead to negative mental and physical health outcomes for caregivers and predict caregiver decisions to institutionalize PWD. Resources to Enhance Alzheimer's Caregiver Health - VA (REACH VA), has demonstrated its ability to improve caregiver burden, emotional and physical well-being, social support and management of behavioral symptoms. Although REACH VA represents one of the best available approaches to help caregivers, treatment non-response and modest treatment effects remain significant issues. A variety of factors may be associated with non-response to behavioral intervention - one particularly robust predictor of non-response is interpersonal skill and communication.

Objectives:

The goal of this research project is the first step toward systematically identifying and addressing caregiver interpersonal challenges using telehealth technology. This project involves three interrelated activities: (1) refinement and pilot testing of a video based observational coding manual (OCM) to evaluate interpersonal skills of family caregivers interacting with PWD (2) development of a treatment manual integrally linked to the OCM and (3) assessment of the feasibility of delivering the treatment.

Methods:

1. We will convene an Expert Advisory Panel (EAP) with expertise in interpersonal and family caregiving processes and family psychotherapy to provide feedback on the OCM. The OCM represents an adaptation of previously established and reliable coding manuals developed for assessing interaction patterns in couples, families, and dementia caregiver research. Using an iterative process of refinement based on EAP feedback, pilot coding of video from five initial dyads, and feedback from those dyads we will use coding schemes originally developed for research and adapt them for clinical use. We will then recruit 15 additional dyads and videotape their interactions. Five Psychology Trainees will be trained on the OCM. The PI and pairs of Psychology Trainees will independently code each video to assess validity, reliability, and analyze qualitative data from semi-structured interviews of caregivers, care-recipients, and clinicians to assess acceptability and utility of the OCM.

2. We will draft a treatment manual for a family intervention informed by established empirically supported interventions for couples and families. The treatment manual will target the identified interpersonal skills deficits in the OCM. A draft of the Treatment Manual will be presented to the EAP, eliciting feedback for further refinement. We will pilot test the family intervention via telehealth with the dyads who received the OCM and treatment.

3. We will assess for feasibility of delivery, and dyad benefit from dyad and therapist report, and descriptive analyses of changes in interpersonal conflict, caregiver depression, anxiety, and burden.

Status:

The project team is convening the EAP and implementing the telehealth logistics necessary to begin recording Wave 1 of dyads.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
20
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Dementia Family Caregiver Burden and Conflict
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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

Other Names
Study Groups/Cohorts
Intervention Group
Caregiver and patient with dementia dyads who receive the family intervention.

Study Arms
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

Arm Intervention/Treatment
Experimental Intervention Group
Caregiver and patient with dementia dyads who receive the family intervention.
Behavioral : Telemental Health Family Intervention

Recruitment Information

Recruitment Status:Recruiting
Enrollment20
Completion DateApril 15, 2019
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03116464
Other Study ID Numbers
PPO 16-131
I21HX002256
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Cory K. Chen, PhD
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY