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Voices Of Individuals: Challenges and Experiences Of bvFTD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060082
Recruitment Status : Enrolling by invitation
First Posted : August 16, 2019
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
The VOICE Of bvFTD study is a telephone interview research study about life with or at risk for behavioral variant frontotemporal dementia (bvFTD). The study aims to understand how bvFTD impacts individuals' day to day lives, how people think about themselves, and what challenges they face.

Condition or disease Intervention/treatment
Frontotemporal Dementia Frontotemporal Degeneration Frontotemporal Dementia, Behavioral Variant FTD Other: Telephone Interview

Detailed Description:

The VOICE Of bvFTD study is a study being conducted at the University of Pennsylvania. The study was developed and initiated in collaboration with the Johns Hopkins Bloomberg School of Public Health and the National Human Genome Research Institute. The goal of this study is to learn more about what it is like to live with or at high risk of developing behavioral variant frontotemporal dementia (bvFTD). The study will involve telephone interviews to help learn as much as possible about living with bvFTD. The hope is that this will guide future research, resource development, and clinical practice.

Participants will have at least two phone calls from the study team. During the initial phone call, which will take about 15 to 20 minutes, the participant will be asked some basic questions about demographics and the study details will be reviewed as part of the consent process. During another call the participant will be asked some questions to assess his or her thinking, and will complete the interview which will last about 30 to 60 minutes. There are no physical or medical procedures included in this study. The consent process, screening, interview scheduling, and the interview itself will take place over two or three phone calls, which may occur over several weeks.

A person may be able to take part in this study if they are a person with bvFTD, or if they have been found to have a genetic change that causes bvFTD.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: VOICE Of bvFTD [Voices Of Individuals: Challenges and Experiences Of bvFTD]
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Persons Diagnosed
Individuals with a diagnosis of bvFTD.
 Other: Telephone Interview
Participants will be asked to answer questions about their experiences with FTD.
Persons At Risk
Individuals with a known genetic risk factor for bvFTD: people with genetic testing that identified a disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family
 Other: Telephone Interview
Participants will be asked to answer questions about their experiences with FTD.


Outcome Measures
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Primary Outcome Measures :
  1. Affective and Behavioral Responses [ Time Frame: Through study completion: about 1.5-2 hours total over several weeks ]
    How participants describe and categorize their emotional reactions to receiving a diagnosis of bvFTD or positive genetic testing result, and their experiences living with that knowledge. It will also explore how patients describe their behavior in response to the testing or diagnosis, such as use of coping strategies, challenges faced, and decisions to disclose their status to family and friends.


Eligibility Criteria
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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
Sampling Method:   Non-Probability Sample
Study Population
Participants for the study will be recruited through the University of Pennsylvania and ClinicalTrials.gov. Previously, participants were also recruited through Johns Hopkins University, through a dementia research study at the National Institutes of Health, through the Penn FTD Center Caregiver Conference, and through through a private Facebook group for individuals with C9orf72 mutations.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Speak fluent English
  • People with bvFTD must have been diagnosed with behavioral variant frontotemporal degeneration (bvFTD)
  • People with a known genetic risk factor for bvFTD must have an identified disease-causing change in a gene that is known to cause bvFTD, such as in C9ORF72, MAPT, GRN, VCP, TARDBP, CHMP2B, or another gene that has been identified as causing FTD in the family
  • The diagnosis or genetic testing results must have been disclosed to the participant at least two months prior to study enrollment

Exclusion Criteria:

  • Inability to complete the informed consent comprehension process
  • Under 18 years of age
  • Does not speak English
  • Received diagnosis or testing result less than two months prior to study enrollment
Contacts and Locations
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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): NCT04060082


Locations
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United States, Maryland
Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21287
National Institutes of Health (NIH)
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
University of Pennsylvania (Penn Frontotemporal Degeneration Center)
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Jill Owczarzak, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Murray Grossman, MDCM, EdD University of Pennsylvania
Principal Investigator: Lori Erby, PhD, ScM National Institutes of Health (NIH)
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04060082    
Other Study ID Numbers: 833507
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
FTD
Interview
Genetics
Persons diagnosed
Frontotemporal degeneration
bvFTD
 Chromosome 9 open reading frame 72 (C9ORF72)
Microtubule-associated protein tau (MAPT)
Progranulin (GRN)
TAR DNA-binding protein (TARDBP)
Valosin-Containing Protein (VCP)
Charged multivesicular body protein 2B (CHMP2B)
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