GEnetic Counseling Through Virtual Visits in Parkinson's Disease (GET-VIRTUAL)

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: Parkinson Disease
• Intervention / Treatment: Other: IMAGINE-PD; Other: Telephone genetic counseling; Other: Virtual genetic counseling

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): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania Parkinsons Disease and Movement Disorders Center

Participation Criteria

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
• Montreal Cognitive Assessment (MoCA) < 21, or a prior diagnosis of dementia during the screening phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

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.	Other: IMAGINE-PD; 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.; Other: Virtual genetic counseling; 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.
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.	Other: IMAGINE-PD; 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.; Other: Telephone genetic counseling; 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.	Other: Telephone genetic counseling; 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.; Other: Virtual genetic counseling; 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.
Active Comparator: Virtual/Virtual; Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.	Other: Virtual genetic counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic Counseling Satisfaction (Pre-Test)	Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)	Immediately after pre-test education/counseling
Depression	Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)	3 months after disclosure counseling
Depression	Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)	6 months after disclosure counseling
State-Trait Anxiety Index-State Score	State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 of the total 40 items included in the State Score are predefined according to the validated scale.	3 months after disclosure counseling
State-Trait Anxiety Index -State Score	State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.	6 months after disclosure counseling
State-Trait Anxiety Index -Trait Score	State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.	3 months after disclosure counseling
State-Trait Anxiety Index -Trait Score	State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.	6 months after disclosure counseling
Quality of Life in Parkinson's Disease	Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.	3 months after disclosure counseling
Quality of Life in Parkinson's Disease	Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.	6 months after disclosure counseling
Test-Related Distress	Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)	6 months after disclosure counseling

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Thomas F Tropea, DO, University of Pennsylvania

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• 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. 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.
• 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