GET-VIRTUAL: GEnetic Counseling Through Virtual Visits in Parkinson's Disease
Study Details
Study Description
Brief Summary
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 PennChart/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: 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.
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.
|
| 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 PennChart/EPIC electronic medical record dashboard.
|
Outcome Measures
Primary Outcome Measures
- Knowledge [4 weeks after pre-testing counseling]
Genetics Knowledge Scale (24-question scale, score range 0-24, higher scores mean greater knowledge)
- 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)
Secondary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form
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Stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study
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Male or female, over the age of 21.
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English Speaking
Exclusion Criteria:
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Prior genetic counseling and/or clinical testing specifically for Parkinson's disease
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MoCA < 21, or a prior diagnosis of dementia during the screening phase
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania Parkinsons Disease and Movement Disorders Center | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
- Principal Investigator: Thomas F Tropea, DO, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 843748
- PCPM