GEnetic Counseling Through Virtual Visits in Parkinson's Disease
GET-VIRTUAL
GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
2 other identifiers
interventional
370
1 country
1
Brief Summary
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jan 2021
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedResults Posted
Study results publicly available
March 11, 2025
CompletedMarch 11, 2025
February 1, 2025
2.8 years
August 21, 2020
November 4, 2024
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Genetics Knowledge
Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
4 weeks after pre-testing education/counseling
Genetic Counseling Satisfaction (Post-Test)
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Immediately after disclosure counseling
Test-Related Distress
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
3 months after disclosure counseling
Secondary Outcomes (10)
Genetic Counseling Satisfaction (Pre-Test)
Immediately after pre-test education/counseling
Depression
3 months after disclosure counseling
Depression
6 months after disclosure counseling
State-Trait Anxiety Index-State Score
3 months after disclosure counseling
State-Trait Anxiety Index -State Score
6 months after disclosure counseling
- +5 more secondary outcomes
Study Arms (4)
IMAGINE-PD/Virtual
EXPERIMENTALPre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via virtual visit with a genetic counselor.
IMAGINE-PD/Telephone
EXPERIMENTALPre-test genetic counseling through the Interactive Multimedia Approach to Genetic counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) website. Genetic results disclosure via telephone with a genetic counselor.
Virtual/Telephone
EXPERIMENTALPre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.
Virtual/Virtual
ACTIVE COMPARATORPre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.
Interventions
The Interactive, Multimedia Approach to Genetic Counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) is a novel, interactive, web-based, audiovisual, self-guided, genetic counseling tool in the development phase. Essential genetic counseling themes, outlined by a senior certified clinical genetics counselor in accordance with national guidelines, are presented in a web-based format, utilizing videos, text, pictures, and audio. Participants can interact with IMAGINE-PD at their own pace, with the ability to move backward and forward, repeat sections, and have the ability to submit questions to the genetic counselor via e-mail.
The virtual visits will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors. The counseling visit will be conducted in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans) within the Penn Chart/Epic electronic medical record dashboard.
The telephone counseling will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors.
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
- Male or female, over the age of 21.
- English Speaking
You may not qualify if:
- Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
- Montreal Cognitive Assessment (MoCA) \< 21, or a prior diagnosis of dementia during the screening phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania Parkinsons Disease and Movement Disorders Center
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rachel Paul, Genetic Counselor
- Organization
- UPenn
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas F Tropea, DO
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 26, 2020
Study Start
January 1, 2021
Primary Completion
October 15, 2023
Study Completion
November 1, 2023
Last Updated
March 11, 2025
Results First Posted
March 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Upon request by collaborators and upon publication of scientific manuscripts.
- Access Criteria
- Approval by the BRAC
All data and isolated DNA samples will be stored for future research purposes for an indefinite amount of time. Individual participant data (IPD) may be shared with other research, academic, and medical institutions, other researchers, drug and device companies, biotechnology companies and others. In the event of such a collaboration, no personally identifying information will be shared. Potential collaborators may apply with a description of the proposed project. This application is then evaluated by a Biospecimen Review Access Committee (BRAC). Only projects deemed to have scientific or clinical merit will be considered eligible to receive samples or information, from which personally identifying information will be removed.