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

February 19, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Genetics Knowledge
Time Frame: 4 weeks after pre-testing education/counseling
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)
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
Test-Related Distress
Time Frame: 3 months after disclosure counseling
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genetic Counseling Satisfaction (Pre-Test)
Time Frame: Immediately after pre-test education/counseling
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Immediately after pre-test education/counseling
Depression
Time Frame: 3 months after disclosure counseling
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
3 months after disclosure counseling
Depression
Time Frame: 6 months after disclosure counseling
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
Time Frame: 3 months after disclosure counseling
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
Time Frame: 6 months after disclosure counseling
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
Time Frame: 3 months after disclosure counseling
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
Time Frame: 6 months after disclosure counseling
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
Time Frame: 3 months after disclosure counseling
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
Time Frame: 6 months after disclosure counseling
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
Time Frame: 6 months after disclosure counseling
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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