Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers

NCT04686266 | Completed Results DMC

• 1 other identifier: 843660
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Variant of Frontotemporal Dementia; Caregiver Stress Syndrome

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 months

• Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)

  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).

  6 months

Secondary Outcomes (5)

• Change From Baseline in Perceived Stress Scale

  6 months

• Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)

  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 Arms (2)

ViCCY: Health Information + Health Coaching

EXPERIMENTAL

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

Behavioral: Health Information + Health Coaching

Health Information

NO INTERVENTION

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

Interventions

Health Information + Health Coaching BEHAVIORAL

Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research

Also known as: ViCCY

ViCCY: Health Information + Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, School of Nursing

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

As this was a pilot study, it was not sufficiently powered to observe effects on all dimensions of the Self-Care Inventory or our secondary outcome measures. Our caregivers had a high level of education, which is related to socioeconomic status, and it will be important for future studies to examine other social determinants of health and how that affects self-care.

Results Point of Contact

• Title: Lauren Massimo, PhD, CRNP
• Organization: University of Pennsylvania

lmassimo@upenn.edu

215-349-5863

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The Health Coaches providing the intervention and the caregiver participants will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: December 16, 2020
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: February 14, 2025
• Results First Posted: March 28, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of our major trial data, we will share data with Penn trainees
• Access Criteria: The Principal Investigator will personally review requests from students for use of the data. She will approve requests based on the importance of the questions asked. She will personally oversee progress in analysis and the publication of abstracts and articles based on the data

Locations

US (1)