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Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers (ViCCY)

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ClinicalTrials.gov Identifier: NCT04686266
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Behavioral Variant of Frontotemporal Dementia Caregiver Stress Syndrome Behavioral: Health Information + Health Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The Health Coaches providing the intervention and the caregiver participants will not be blinded.
Primary Purpose: Treatment
Official Title: Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023


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
Behavioral: 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
Other Name: ViCCY

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



Primary Outcome Measures :
  1. Change from Baseline in the Self-Care Inventory [ Time Frame: 3 months and 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.

  2. Change from Baseline in Frontotemporal Dementia Rating Scale [ Time Frame: 3 months and 6 months ]
    Commonly used scale to quantify behavioral and psychological symptoms of dementia


Secondary Outcome Measures :
  1. Change from Baseline in Perceived Stress Scale [ Time Frame: 3 months and 6 months ]
    The Perceived Stress Scale, 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. Cronbachs alpha of the scale ranges from 0.84 to 0.86, and was 0.91 for older African American and European American females.

  2. Change from Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 3 months and 6 months ]
    CES-D is a valid and reliable scale for detecting caregiver depression in dementia.

  3. Change from Baseline in Ways of Coping Questionnaire, short form [ Time Frame: 3 months and 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.

  4. Change from Baseline in Zarit Burden Interview (ZBI) [ Time Frame: 3 months and 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).

  5. Change from Baseline in Medical Outcomes Study Short Form (SF-36) [ Time Frame: 3 months and 6 months ]
    subjective review of caregiver health information

  6. Change from Baseline in Neuropsychiatric Inventory [ Time Frame: 3 months and 6 months ]
    Commonly used scale to quantify behavioral and psychological symptoms of dementia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686266


Contacts
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Contact: Michelle Sharkey 610-246-5855 mchll409@upenn.edu
Contact: Gladys Thomas glthomas@nursing.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania, School of Nursing Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lauren Massimo, PhD, CRNP    215-349-8463    lauren.massimo@pennmedicine.upenn.edu   
Principal Investigator: Barbara Riegel, PhD, RN         
Sub-Investigator: Lauren Massimo, PhD, CRNP         
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04686266    
Other Study ID Numbers: 843660
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication of our major trial data, we will share data with Penn trainees
Access Criteria: The Principal Investigator will personally review requests from students for use of the data. She will approve requests based on the importance of the questions asked. She will personally oversee progress in analysis and the publication of abstracts and articles based on the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations