- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04686266
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers (ViCCY)
Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania, School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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
Other Names:
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No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Self-Care Inventory (SCI)
Time Frame: 6 months
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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.
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6 months
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Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Time Frame: 6 months
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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).
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Perceived Stress Scale
Time Frame: 6 months
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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.
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6 months
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Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 6 months
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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.
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6 months
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Change From Baseline in Ways of Coping Questionnaire, Short Form
Time Frame: 6 months
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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.
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6 months
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Change From Baseline in Zarit Burden Interview (ZBI)
Time Frame: 6 months
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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).
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6 months
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Change From Baseline in Neuropsychiatric Inventory
Time Frame: 6 months
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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 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.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- 843660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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