Dementia Family Caregiver Burden and Conflict Clinical Trial
— TMH PilotOfficial title:
Family Telemental Health Intervention for Veterans With Dementia
| Verified date | February 2023 |
| Source | VA Office of Research and Development |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 20 |
| Est. completion date | December 30, 2023 |
| Est. primary completion date | December 30, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Post Treatment, an average of 12-18 weeks | |
| Secondary | 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. | Post Treatment, an average of 12-18 weeks | |
| Secondary | 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). | Post Treatment, an average of 12-18 weeks | |
| Secondary | 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. | Post Treatment, an average of 12-18 weeks |