Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
CompletedNAResults postedLast updated 14 February 2025
What this trial tests
NA trial testing Health Information + Health Coaching in Behavioral Variant of Frontotemporal Dementia in 43 participants. Completed in 3 November 2021.
18 and older, any sex, with Behavioral Variant of Frontotemporal Dementia or Caregiver Stress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Self-Care Inventory (SCI)Primary· 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.
SCI Maintenance Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
71.4
± 14.1
Health Information
66.4
± 18.3
SCI Maintenance Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
80.4
± 12.0
Health Information
68.9
± 14.7
SCI Management Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
54.6
± 21.2
Health Information
56.5
± 23.7
SCI Management Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
70.7
± 15.6
Health Information
59.4
± 26.9
SCI Monitoring Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
60.5
± 19.8
Health Information
64.6
± 25.3
SCI Monitoring Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
77.8
± 16.6
Health Information
64.0
± 24.4
SCI Confidence Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
66.3
± 20.1
Health Information
68.1
± 22.3
SCI Confidence Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
79.6
± 18.7
Health Information
65.3
± 23.5
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)Primary· 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).
Q1- Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.67
± 0.49
Health Information
1.67
± 0.49
Q1- Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.93
± 0.46
Health Information
1.73
± 0.80
Q2- Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.47
± 0.74
Health Information
1.53
± 0.64
Q2- Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.53
± 0.64
Health Information
1.60
± 0.83
Q3- Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
2.14
± 0.77
Health Information
2.13
± 0.52
Q3- Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
2.13
± 0.64
Health Information
2.13
± 0.52
Q4- Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.73
± 0.70
Health Information
1.80
± 0.56
Q4- Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
1.93
± 0.46
Health Information
1.93
± 0.59
Change From Baseline in Perceived Stress ScaleSecondary· 6 months
The Perceived Stress Scale is a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress.
Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
23.1
± 10.0
Health Information
29.2
± 8.7
Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
23.4
± 12.4
Health Information
28.4
± 8.3
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)Secondary· 6 months
CES-D is a valid and reliable scale for detecting caregiver depression in dementia. The scoring is on a likert scale 0: Rarely or none of the time (less than 1 day), 1: Some or a little of the time (1-2 days), 2: Occasionally or a moderate amount of time (3-4 days), and 3: Most or all of the time (5-7 days). Higher scores represent greater depressive symptoms. Total scores can range 0 to 60. A score equal or above a 16 means a person is at risk for clinical depression.
Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
19.7
± 15.1
Health Information
19.0
± 12.8
Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
15.3
± 11.3
Health Information
16.6
± 10.4
Change From Baseline in Ways of Coping Questionnaire, Short FormSecondary· 6 months
This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers.
Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
22.7
± 16.0
Health Information
20.4
± 15.0
Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
23.4
± 15.9
Health Information
19.1
± 14.6
Change From Baseline in Zarit Burden Interview (ZBI)Secondary· 6 months
The ZBI has been used in numerous informal dementia caregiver studies to capture burden associated with providing care to a loved one. Total scores are summed and a range is provided for little to no burden (0-21) to severe burden (61-88).
Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
38.4
± 11.4
Health Information
43.6
± 13.6
Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
39.3
± 14.9
Health Information
46.3
± 12.8
Change From Baseline in Neuropsychiatric InventorySecondary· 6 months
Commonly used scale to evaluate 12 common behaviors in dementia including Delusions, Hallucinations, Agitation/Aggression, Depression, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability, Aberrant motor behavior, Sleep and Nighttime Behavior Disorders, Appetite and Eating Disorders. Ratings include the frequency of the occurrence of behaviors (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and the level of severity of behaviors (1 = mild, 2 = moderate, 3 = severe). The behavioral domain total score is the product of the frequency score multiplied by
Baseline
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
20.4
± 15.7
Health Information
23.4
± 17.3
Month 6
Group
Value
95% CI
ViCCY: Health Information + Health Coaching
14.6
± 8.2
Health Information
23.8
± 15.4
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 14 February 2025
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