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GEnetic Counseling Through Virtual Visits in Parkinson's Disease (GET-VIRTUAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527146
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Tropea, DO, University of Pennsylvania

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
Parkinson Disease Other: IMAGINE-PD Other: Virtual genetic counseling Other: Telephone genetic counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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)
Primary Purpose: Other
Official Title: GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Knowledge [ Time Frame: 4 weeks after pre-testing counseling ]
    Genetics Knowledge Scale

  2. Genetic Counseling Satisfaction [ Time Frame: Immediately after disclosure counseling ]
    Genetic Counseling Satisfaction Scale (GCSS)

  3. Impact [ Time Frame: 3 months after genetic results disclosure ]
    Revised Impact of Events Scale


Secondary Outcome Measures :
  1. Genetic Counseling Outcomes [ Time Frame: 6 months after genetic counseling ]
    Genetic Counseling Outcomes Scale (GCOS)

  2. Depression [ Time Frame: Immediately after results disclosure and 6 months after counseling ]
    Geriatric Depression Scale (GDS)

  3. Anxiety [ Time Frame: Immediately after results disclosure and 6 months after counseling ]
    State-Trait Anxiety Index

  4. Quality of life in Parkinson's disease [ Time Frame: Immediately after results disclosure and 6 months after counseling ]
    Parkinsons disease quality of life 39 scale (PDQ39)

  5. Suicidal Behaviors [ Time Frame: Immediately after results disclosure and 6 months after counseling ]
    C-SSRS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • MoCA < 21, or a prior diagnosis of dementia during the screening phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527146


Contacts
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Contact: Thomas F Tropea, DO 2168297731 thomas.tropea@pennmedicine.upenn.edu

Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Thomas F Tropea, DO University of Pennsylvania
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Responsible Party: Thomas Tropea, DO, Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04527146    
Other Study ID Numbers: 843748
PCPM ( Other Identifier: Penn Center for Precision Medicine )
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data and isolated DNA samples will be stored for future research purposes for an indefinite amount of time. IPD may be shared with other research, academic, and medical institutions, other researchers, drug and device companies, biotechnology companies and others. In the event of such a collaboration, no personally identifying information will be shared. Potential collaborators may apply with a description of the proposed project. This application is then evaluated by a Biospecimen Review Access Committee (BRAC). Only projects deemed to have scientific or clinical merit will be considered eligible to receive samples or information, from which personally identifying information will be removed.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon request by collaborators and upon publication of scientific manuscripts.
Access Criteria: Approval by the BRAC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases