Clinical trial NCT04686266: Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
Official title: Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Variant of Frontotemporal Dementia
Caregiver Stress Syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Self-Care Inventory (SCI)
timeFrame: 6 months
measure: Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Perceived Stress Scale
timeFrame: 6 months
measure: Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 months
measure: Change From Baseline in Ways of Coping Questionnaire, Short Form
timeFrame: 6 months
measure: Change From Baseline in Zarit Burden Interview (ZBI)
timeFrame: 6 months
measure: Change From Baseline in Neuropsychiatric Inventory
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, School of Nursing
state: Pennsylvania
Study officials:
References: