GEnetic Counseling Through Virtual Visits in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: IMAGINE-PD; Other: Virtual genetic counseling; Other: Telephone genetic counseling

• Registration Number: NCT04527146
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-26
• Study Start: 2021-01-01
• Primary Completion: 2023-10-15
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IMAGINE-PD/Virtual	Virtual genetic counseling	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.
IMAGINE-PD/Telephone	IMAGINE-PD	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.
IMAGINE-PD/Virtual	IMAGINE-PD	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.
Virtual/Virtual	Virtual genetic counseling	Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.
IMAGINE-PD/Telephone	Telephone genetic counseling	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.
Virtual/Telephone	Telephone genetic counseling	Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.
Virtual/Telephone	Virtual genetic counseling	Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.

Primary Outcome Measures

Name	Time	Method
Genetic Counseling Satisfaction	Immediately after disclosure counseling	Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Impact	3 months after genetic results disclosure	Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Knowledge	4 weeks after pre-testing counseling	Genetics Knowledge Scale (24-question scale, score range 0-24, higher scores mean greater knowledge)

Secondary Outcome Measures

Name	Time	Method
Genetic Counseling Outcomes	6 months after genetic counseling	Genetic Counseling Outcomes Scale (GCOS, 24-item scale)
Depression	Immediately after results disclosure and 6 months after counseling	Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Anxiety	Immediately after results disclosure and 6 months after counseling	State-Trait Anxiety Index (STAI, 20-item, max score 80, higher means greater anxiety)
Quality of life in Parkinson's disease	Immediately after results disclosure and 6 months after counseling	Parkinsons disease quality of life 39 scale (PDQ39)

Trial Locations

Locations (1)

University of Pennsylvania Parkinsons Disease and Movement Disorders Center; 🇺🇸 Philadelphia, Pennsylvania, United States