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Clinical Trials/NCT04686266
NCT04686266
Completed
N/A

Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia

University of Pennsylvania1 site in 1 country43 target enrollmentDecember 16, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Behavioral Variant of Frontotemporal Dementia
Sponsor
University of Pennsylvania
Enrollment
43
Locations
1
Primary Endpoint
Change From Baseline in the Self-Care Inventory (SCI)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2020
End Date
November 3, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline in the Self-Care Inventory (SCI)

Time Frame: 6 months

30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.

Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)

Time Frame: 6 months

The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of "never" (0) to "all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior).

Secondary Outcomes

  • Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)(6 months)
  • Change From Baseline in Perceived Stress Scale(6 months)
  • Change From Baseline in Ways of Coping Questionnaire, Short Form(6 months)
  • Change From Baseline in Zarit Burden Interview (ZBI)(6 months)
  • Change From Baseline in Neuropsychiatric Inventory(6 months)

Study Sites (1)

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