GEnetic Counseling Through Virtual Visits in Parkinson's Disease

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

Detailed Description
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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.

Official Title
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GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: IMAGINE-PD
* Other: Virtual genetic counseling
* Other: Telephone genetic counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Enrolled participants will be randomized into one of 4 groups based on pre- and post-genetic test counseling: (1)IMAGINE-PD/Virtual, (2)IMAGINE-PD/Telephone, (3)Virtual/Virtual, and (4)Virtual/Telephone.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMAGINE-PD/Virtual<br>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<br>* 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.<br>Other: Virtual genetic counseling<br>* 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.<br>|
| Experimental: IMAGINE-PD/Telephone<br>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<br>* 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.<br>Other: Telephone genetic counseling<br>* 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.<br>|
| Experimental: Virtual/Telephone<br>Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor. | Other: Virtual genetic counseling<br>* 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.<br>Other: Telephone genetic counseling<br>* 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.<br>|
| Active Comparator: Virtual/Virtual<br>Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor. | Other: Virtual genetic counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge | Genetics Knowledge Scale (24-question scale, score range 0-24, higher scores mean greater knowledge) | 4 weeks after pre-testing counseling | 
| Genetic Counseling Satisfaction | Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction) | Immediately after disclosure counseling | 
| 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 Outcome Measures

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