Clinical trial NCT04060082: Voices Of Individuals: Challenges and Experiences Of bvFTD
Official title: VOICE Of bvFTD [Voices Of Individuals: Challenges and Experiences Of bvFTD]
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Frontotemporal Dementia
Frontotemporal Degeneration
Frontotemporal Dementia, Behavioral Variant
FTD
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)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Affective and Behavioral Responses
timeFrame: Through study completion: about 1.5-2 hours total over several weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institution
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health (NIH)
state: Maryland
city: Philadelphia
country: United States
facility: University of Pennsylvania (Penn Frontotemporal Degeneration Center)
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Jill Owczarzak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: Lori Erby, PhD, ScM
role: PRINCIPAL_INVESTIGATOR
References: