Voices Of Individuals: Challenges and Experiences Of bvFTD

Sponsor

University of Pennsylvania (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04060082

Collaborator

(none)

Enrollment

Locations

41.2

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Jun 26, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Medical Institution	Baltimore	Maryland	United States	21287
2	National Institutes of Health (NIH)	Bethesda	Maryland	United States	20892
3	University of Pennsylvania (Penn Frontotemporal Degeneration Center)	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

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)