GEnetic Counseling Through Virtual Visits in Parkinson's Disease

NCT ID: NCT04527146

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-11-01

Brief Summary

The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IMAGINE-PD

Intervention Type: OTHER

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.

Virtual genetic counseling

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

IMAGINE-PD

Intervention Type: OTHER

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.

Telephone genetic counseling

Intervention Type: OTHER

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.

Virtual/Telephone

Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.

Group Type: EXPERIMENTAL

Virtual genetic counseling

Intervention Type: OTHER

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.

Telephone genetic counseling

Intervention Type: OTHER

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.

Virtual/Virtual

Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.

Group Type: ACTIVE_COMPARATOR

Virtual genetic counseling

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Thomas Tropea, DO

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas F Tropea, DO

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Parkinsons Disease and Movement Disorders Center

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PCPM

Identifier Type: OTHER

Identifier Source: secondary_id

843748

Identifier Type: -

Identifier Source: org_study_id