Voices Of Individuals: Challenges and Experiences Of bvFTD

NCT04060082 | Completed

• 1 other identifier: 833507
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

Frontotemporal Degeneration; Frontotemporal Dementia, Behavioral Variant; FTD; Frontotemporal Dementia

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Persons Diagnosed

Individuals with a diagnosis of bvFTD.

Other: Telephone Interview

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

Interventions

Telephone Interview OTHER

Participants will be asked to answer questions about their experiences with FTD.

Persons At Risk; Persons Diagnosed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Johns Hopkins Medical Institution

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health (NIH)

Bethesda, Maryland, 20892, United States

Location

University of Pennsylvania (Penn Frontotemporal Degeneration Center)

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Frontotemporal Dementia; Pick Disease of the Brain; Frontotemporal Dementia With Motor Neuron Disease; Inclusion Body Myopathy With Early-Onset Paget Disease And Frontotemporal Dementia

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jill Owczarzak, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Lori Erby, PhD, ScM

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: June 26, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)