GEnetic Counseling Through Virtual Visits in Parkinson's Disease

Parkinson Disease Clinical Trial

— GET-VIRTUAL  

Official title:

GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527146
• Other study ID #: 843748
• Secondary ID: PCPM
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 1, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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 PennChart/EPIC electronic medical record dashboard.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania Parkinsons Disease and Movement Disorders Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	Genetics Knowledge Scale (24-question scale, score range 0-24, higher scores mean greater knowledge)	4 weeks after pre-testing counseling
Primary	Genetic Counseling Satisfaction	Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)	Immediately after disclosure counseling
Primary	Impact	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	Genetic Counseling Outcomes	Genetic Counseling Outcomes Scale (GCOS, 24-item scale)	6 months after genetic counseling
Secondary	Depression	Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)	Immediately after results disclosure and 6 months after counseling
Secondary	Anxiety	State-Trait Anxiety Index (STAI, 20-item, max score 80, higher means greater anxiety)	Immediately after results disclosure and 6 months after counseling
Secondary	Quality of life in Parkinson's disease	Parkinsons disease quality of life 39 scale (PDQ39)	Immediately after results disclosure and 6 months after counseling