Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers (ViCCY)

University of Pennsylvania

Status: Completed

Conditions: Caregiver Stress Syndrome; Behavioral Variant of Frontotemporal Dementia

Treatments: Behavioral: Health Information + Health Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT04686266

843660

Details and patient eligibility

About

The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.

Full description

Informal caregivers of persons with Frontotemporal degeneration (FTD) are an understudied population with unique needs. FTD is a common cause of young-onset dementia with no known cure. Behavioral variant FTD (bvFTD) is the most common of the FTD syndromes and involves a progressive disorder of emotional regulation and personality, and significant impairment in executive function. bvFTD caregivers face unique challenges which are particularly stressful, including young age at which the disorder appears, behavioral symptoms like apathy and disinhibition that are severe and appear early in bvFTD, and the lack of appropriate supportive services. Indeed, numerous studies have demonstrated that stress, depression and burden are higher in FTD caregivers than in any of the other ADRDs, yet caregiver interventions tested in specifically in the FTD population have been limited to a few small studies that focus on education around patient behavior management, not caregiver self-care.

The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.

30 caregivers will be randomized 1:1 to a health information: health information + health coaching group. Catered information will be delivered via tablets over 6 months with testing dispersed at baseline, 1 month, 3 months, and 6 months.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informal caregiver providing care at least 8 hours/week
• Reporting poor self-care on screening (Health Self-Care Neglect Scale, score ≥ 2)
• Able to complete the protocol, e.g., adequate vision and hearing, English speaking
• Caregiver of a patient diagnosed bvFTD

Exclusion criteria

• Participation in another support randomized, controlled trial
• Untreated major psychiatric illness (Use of anti-anxiety/anti-depressant medicines is acceptable and will be adjusted in analysis if group imbalance is identified.)
• Caregiver with Cognitive Impairment based on Telephone Interview for Cognitive Status (TICS) score <25

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups

ViCCY: Health Information + Health Coaching

Experimental group

Description:

This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time

Treatment:

Behavioral: Health Information + Health Coaching

Health Information

No Intervention group

Description:

Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites