Trial Outcomes & Findings for Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers (NCT NCT04686266)
NCT ID: NCT04686266
Last Updated: 2025-02-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
6 months
Results posted on
2025-02-14
Participant Flow
Participants were recruited by clinician referral from the University of Pennsylvania Frontotemporal Degeneration Center between December 2020 to April 2021. The first participant was enrolled in December 2020 and the final was enrolled in April 2021. Data collection began in December 2020 and finished in November 2021.
Of 43 people contacted for recruitment, 8 declined to participate and 4 were ineligible. 31 were randomized to the protocol.
Participant milestones
| Measure |
ViCCY: Health Information + Health Coaching
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
Health Information + Health Coaching: 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
|
Health Information
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
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|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
Month 1
|
15
|
16
|
|
Overall Study
Month 3
|
15
|
15
|
|
Overall Study
Month 6
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
ViCCY: Health Information + Health Coaching
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
Health Information + Health Coaching: 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
|
Health Information
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
Baseline characteristics by cohort
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
62.80 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
65.07 years
STANDARD_DEVIATION 9.95 • n=7 Participants
|
63.93 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race of Caregiver · Black or AA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race of Caregiver · White or Caucasian
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race of Caregiver · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race of Caregiver · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race of Caregiver · Multi-Racial
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education of Caregiver (years)
Grade School
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education of Caregiver (years)
High School graduate or GED
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education of Caregiver (years)
Trade School or some college
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education of Caregiver (years)
Bachelor's Degree
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education of Caregiver (years)
Doctoral or Professional Degree
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Relationship to Patient
Daughter
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Relationship to Patient
Mother
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Relationship to Patient
Spouse
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Relationship to Patient
Other Relative
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Time as Caregiver (years)
|
4.97 years
STANDARD_DEVIATION 2.26 • n=5 Participants
|
4.99 years
STANDARD_DEVIATION 3.26 • n=7 Participants
|
4.98 years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
|
Clinical Dementia Rating Scale-Frontotemporal Lobar Degeneration (global score)
|
1.82 units on a scale
STANDARD_DEVIATION 0.96 • n=5 Participants
|
1.70 units on a scale
STANDARD_DEVIATION 0.75 • n=7 Participants
|
1.77 units on a scale
STANDARD_DEVIATION 0.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months30 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.
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Monitoring Baseline
|
60.5 score on a scale
Standard Deviation 19.8
|
64.6 score on a scale
Standard Deviation 25.3
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Monitoring Month 6
|
77.8 score on a scale
Standard Deviation 16.6
|
64.0 score on a scale
Standard Deviation 24.4
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Confidence Baseline
|
66.3 score on a scale
Standard Deviation 20.1
|
68.1 score on a scale
Standard Deviation 22.3
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Confidence Month 6
|
79.6 score on a scale
Standard Deviation 18.7
|
65.3 score on a scale
Standard Deviation 23.5
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Maintenance Baseline
|
71.4 score on a scale
Standard Deviation 14.1
|
66.4 score on a scale
Standard Deviation 18.3
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Maintenance Month 6
|
80.4 score on a scale
Standard Deviation 12.0
|
68.9 score on a scale
Standard Deviation 14.7
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Management Baseline
|
54.6 score on a scale
Standard Deviation 21.2
|
56.5 score on a scale
Standard Deviation 23.7
|
|
Change From Baseline in the Self-Care Inventory (SCI)
SCI Management Month 6
|
70.7 score on a scale
Standard Deviation 15.6
|
59.4 score on a scale
Standard Deviation 26.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: skipped question by participant
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).
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q1- Baseline
|
1.67 score on a scale
Standard Deviation 0.49
|
1.67 score on a scale
Standard Deviation 0.49
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q1- Month 6
|
1.93 score on a scale
Standard Deviation 0.46
|
1.73 score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q2- Baseline
|
1.47 score on a scale
Standard Deviation 0.74
|
1.53 score on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q2- Month 6
|
1.53 score on a scale
Standard Deviation 0.64
|
1.60 score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q3- Baseline
|
2.14 score on a scale
Standard Deviation 0.77
|
2.13 score on a scale
Standard Deviation 0.52
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q3- Month 6
|
2.13 score on a scale
Standard Deviation 0.64
|
2.13 score on a scale
Standard Deviation 0.52
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q4- Baseline
|
1.73 score on a scale
Standard Deviation 0.70
|
1.80 score on a scale
Standard Deviation 0.56
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q4- Month 6
|
1.93 score on a scale
Standard Deviation 0.46
|
1.93 score on a scale
Standard Deviation 0.59
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q5- Baseline
|
2.00 score on a scale
Standard Deviation 0.53
|
1.93 score on a scale
Standard Deviation 0.59
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q5- Month 6
|
1.93 score on a scale
Standard Deviation 0.59
|
1.93 score on a scale
Standard Deviation 0.80
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q6- Baseline
|
1.73 score on a scale
Standard Deviation 0.80
|
1.73 score on a scale
Standard Deviation 0.46
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q6- Month 6
|
1.67 score on a scale
Standard Deviation 0.49
|
1.87 score on a scale
Standard Deviation 0.74
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q7- Baseline
|
2.13 score on a scale
Standard Deviation 0.92
|
2.00 score on a scale
Standard Deviation 0.76
|
|
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Q7- Month 6
|
2.00 score on a scale
Standard Deviation 0.76
|
1.93 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Perceived Stress Scale
Baseline
|
23.1 score on a scale
Standard Deviation 10.0
|
29.2 score on a scale
Standard Deviation 8.7
|
|
Change From Baseline in Perceived Stress Scale
Month 6
|
23.4 score on a scale
Standard Deviation 12.4
|
28.4 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 6 monthsCES-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.
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Baseline
|
19.7 score on a scale
Standard Deviation 15.1
|
19.0 score on a scale
Standard Deviation 12.8
|
|
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Month 6
|
15.3 score on a scale
Standard Deviation 11.3
|
16.6 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 6 monthsThis 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.
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Ways of Coping Questionnaire, Short Form
Baseline
|
22.7 score on a scale
Standard Deviation 16.0
|
20.4 score on a scale
Standard Deviation 15.0
|
|
Change From Baseline in Ways of Coping Questionnaire, Short Form
Month 6
|
23.4 score on a scale
Standard Deviation 15.9
|
19.1 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 6 monthsThe 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).
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Zarit Burden Interview (ZBI)
Baseline
|
38.4 score on a scale
Standard Deviation 11.4
|
43.6 score on a scale
Standard Deviation 13.6
|
|
Change From Baseline in Zarit Burden Interview (ZBI)
Month 6
|
39.3 score on a scale
Standard Deviation 14.9
|
46.3 score on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 6 monthsCommonly 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 the severity score for that behavior. The NPI total score is the sum of all the individual behavioral domains. Scores range from 0-144. Higher scores demonstrate greater symptoms frequency and severity.
Outcome measures
| Measure |
ViCCY: Health Information + Health Coaching
n=15 Participants
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
Health Information + Health Coaching: 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
|
Health Information
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Neuropsychiatric Inventory
Baseline
|
20.4 score on a scale
Standard Deviation 15.7
|
23.4 score on a scale
Standard Deviation 17.3
|
|
Change From Baseline in Neuropsychiatric Inventory
Month 6
|
14.6 score on a scale
Standard Deviation 8.2
|
23.8 score on a scale
Standard Deviation 15.4
|
Adverse Events
ViCCY: Health Information + Health Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place