- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527146
GEnetic Counseling Through Virtual Visits in Parkinson's Disease (GET-VIRTUAL)
November 2, 2023 updated by: Thomas Tropea, DO, University of Pennsylvania
GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with Parkinson's disease.
Participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods.
In both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence.
The primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale.
The purpose is to develop effective and scalable approaches to genetic counseling.
This work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.
Study Type
Interventional
Enrollment (Actual)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas F Tropea, DO
- Phone Number: 2168297731
- Email: thomas.tropea@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- University of Pennsylvania Parkinsons Disease and Movement Disorders Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
- MoCA < 21, or a prior diagnosis of dementia during the screening phase
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IMAGINE-PD/Virtual
Pre-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.
|
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 PennChart/EPIC electronic medical record dashboard.
|
Experimental: IMAGINE-PD/Telephone
Pre-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.
|
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 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.
|
Experimental: Virtual/Telephone
Pre-test genetic counseling virtual visit with a genetic counselor.
Genetic results disclosure via telephone with a genetic counselor.
|
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 PennChart/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.
|
Active Comparator: Virtual/Virtual
Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.
|
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 PennChart/EPIC electronic medical record dashboard.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge
Time Frame: 4 weeks after pre-testing counseling
|
Genetics Knowledge Scale (24-question scale, score range 0-24, higher scores mean greater knowledge)
|
4 weeks after pre-testing counseling
|
Genetic Counseling Satisfaction
Time Frame: Immediately after disclosure counseling
|
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
|
Immediately after disclosure counseling
|
Impact
Time Frame: 3 months after genetic results disclosure
|
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
|
3 months after genetic results disclosure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic Counseling Outcomes
Time Frame: 6 months after genetic counseling
|
Genetic Counseling Outcomes Scale (GCOS, 24-item scale)
|
6 months after genetic counseling
|
Depression
Time Frame: Immediately after results disclosure and 6 months after counseling
|
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
|
Immediately after results disclosure and 6 months after counseling
|
Anxiety
Time Frame: Immediately after results disclosure and 6 months after counseling
|
State-Trait Anxiety Index (STAI, 20-item, max score 80, higher means greater anxiety)
|
Immediately after results disclosure and 6 months after counseling
|
Quality of life in Parkinson's disease
Time Frame: Immediately after results disclosure and 6 months after counseling
|
Parkinsons disease quality of life 39 scale (PDQ39)
|
Immediately after results disclosure and 6 months after counseling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas F Tropea, DO, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (Actual)
August 26, 2020
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 843748
- PCPM (Other Identifier: Penn Center for Precision Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data and isolated DNA samples will be stored for future research purposes for an indefinite amount of time.
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.
IPD Sharing Time Frame
Upon request by collaborators and upon publication of scientific manuscripts.
IPD Sharing Access Criteria
Approval by the BRAC
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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