Voices Of Individuals: Challenges and Experiences Of bvFTD

• Conditions: FTD; Frontotemporal Degeneration; Frontotemporal Dementia; Frontotemporal Dementia, Behavioral Variant
• Interventions: Other: Telephone Interview

• Registration Number: NCT04060082
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study Start: 2019-06-26
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persons Diagnosed	Telephone Interview	Individuals with a diagnosis of bvFTD.
Persons At Risk	Telephone Interview	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

Primary Outcome Measures

Name	Time	Method
Affective and Behavioral Responses	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.

Trial Locations

Locations (3)

Johns Hopkins Medical Institution; 🇺🇸 Baltimore, Maryland, United States

National Institutes of Health (NIH); 🇺🇸 Bethesda, Maryland, United States

University of Pennsylvania (Penn Frontotemporal Degeneration Center); 🇺🇸 Philadelphia, Pennsylvania, United States