Voices Of Individuals: Challenges and Experiences Of bvFTD

VOICE Of bvFTD [Voices Of Individuals: Challenges and Experiences Of bvFTD]

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.

Study Overview

• Status: Completed
• Conditions: Frontotemporal Degeneration; Frontotemporal Dementia; Frontotemporal Dementia, Behavioral Variant; FTD
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institution
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health (NIH)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania (Penn Frontotemporal Degeneration Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affective and Behavioral Responses	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.	Through study completion: about 1.5-2 hours total over several weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Jill Owczarzak, PhD, Johns Hopkins Bloomberg School of Public Health; Principal Investigator: Lori Erby, PhD, ScM, National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Genetics; Frontotemporal degeneration; Interview; FTD; Persons diagnosed; 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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Frontotemporal Lobar Degeneration; Nutritional and Metabolic Diseases; Frontotemporal Dementia; Pick Disease of the Brain; Frontotemporal Dementia With Motor Neuron Disease; Inclusion Body Myopathy With Early-Onset Paget Disease And Frontotemporal Dementia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 833507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No