Behavioral Variant of Frontotemporal DementiaViCCYNCT04686266
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
A study testing Health Information + Health Coaching in people with Behavioral Variant of Frontotemporal Dementia and Caregiver Stress Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Variant of Frontotemporal Dementia, Caregiver Stress Syndrome
- What is being tested?
- Health Information + Health Coaching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, School of Nursing
Philadelphia, Pennsylvania, 19104
About this study
Official title: Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
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.
Read the 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.
- Being tested
- Health Information + Health Coaching
- Medical subject headings
- Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Information + Health CoachingBehavioural
Also called ViCCY
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 months
Secondary outcomes (5)
Change From Baseline in Perceived Stress Scale
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.
Measured: 6 months
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: 6 months
Change From Baseline in Ways of Coping Questionnaire, Short Form
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.
Measured: 6 months
Change From Baseline in Zarit Burden Interview (ZBI)
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).
Measured: 6 months
Change From Baseline in Neuropsychiatric Inventory
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start16 Dec 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavioral Variant of Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686266
- Sponsor's protocol ID
- 843660
- Acronym
- ViCCY
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2020
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
- ClinicalTrials.gov ID
- NCT04686266
- Acronym / sponsor ID
- ViCCY / 843660
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 28 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViCCY: Health Information + Health Coaching | Experimental | Behavioral: Health Information + Health CoachingThis 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 | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Information + Health CoachingAlso: ViCCYVirtual 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 | Behavioural | ViCCY: Health Information + Health Coaching |
Primary outcome
Change From Baseline in the Self-Care Inventory (SCI)
Time frame: 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.
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
Time frame: 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).
5 secondary outcomes
Change From Baseline in Perceived Stress Scale
Time frame: 6 months
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 months
Change From Baseline in Ways of Coping Questionnaire, Short Form
Time frame: 6 months
Change From Baseline in Zarit Burden Interview (ZBI)
Time frame: 6 months
Change From Baseline in Neuropsychiatric Inventory
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion.
Related trials for Behavioral Variant of Frontotemporal Dementia
RecruitingPhase 1/2
A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)
Frontotemporal Dementia, FTD
Active, not recruitingPhase 2
Clinical Study of Neflamapimod in Patients With Primary Progressive Aphasia
Nonfluent Variant Primary Progressive Aphasia (nfvPPA)
RecruitingObservational study
Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders
Behavioral Variant of Frontotemporal Disorder (bvFTD), Phenocopy Frontotemporal Dementia (phFTD)
Recruiting
Social & Affective Cognition in Alzheimer's Disease & Associated Disorders
Alzheimer's Disease, Frontotemporal Degeneration (Semantic & Behavioral Variants)
RecruitingObservational study
Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases
Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Information + Health Coaching in people with Behavioral Variant of Frontotemporal Dementia and Caregiver Stress Syndrome, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Self-Care Inventory (SCI) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.