N/A
N=31
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
Behavioral Variant of Frontotemporal Dementia · Caregiver Stress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04686266 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change From Baseline in the Self-Care Inventory (SCI) — 71.4; 66.4; 80.4; 68.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health Information + Health Coaching (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Self-Care Inventory (SCI) |
71.4; 66.4; 80.4; 68.9; 54.6; 56.5 | — |
| PRIMARY Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) |
1.67; 1.67; 1.93; 1.73; 1.47; 1.53 | — |
| SECONDARY Change From Baseline in Perceived Stress Scale |
23.1; 29.2; 23.4; 28.4 | — |
| SECONDARY Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) |
19.7; 19.0; 15.3; 16.6 | — |
| SECONDARY Change From Baseline in Ways of Coping Questionnaire, Short Form |
22.7; 20.4; 23.4; 19.1 | — |
| SECONDARY Change From Baseline in Zarit Burden Interview (ZBI) |
38.4; 43.6; 39.3; 46.3 | — |
| SECONDARY Change From Baseline in Neuropsychiatric Inventory |
20.4; 23.4; 14.6; 23.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04686266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.