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Completed

NCT Number: NCT04527146

GEnetic Counseling Through Virtual Visits in Parkinson's Disease

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Parkinsons Disease and Movement Disorders Center

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Montreal Cognitive Assessment (MoCA) < 21, or a prior diagnosis of dementia during the screening phase

Treatment and study plan

IMAGINE-PD

Other

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

Other

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 Penn Chart/Epic electronic medical record dashboard.

Telephone genetic counseling

Other

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.

Primary outcomes

  1. Genetics Knowledge

    Time frame: 4 weeks after pre-testing education/counseling

    Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)

  2. Genetic Counseling Satisfaction (Post-Test)

    Time frame: Immediately after disclosure counseling

    Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)

  3. Test-Related Distress

    Time frame: 3 months after disclosure counseling

    Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)

Secondary outcomes

  1. Genetic Counseling Satisfaction (Pre-Test)

    Time frame: Immediately after pre-test education/counseling

    Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)

  2. Depression

    Time frame: 3 months after disclosure counseling

    Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)

  3. Depression

    Time frame: 6 months after disclosure counseling

    Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)

  4. State-Trait Anxiety Index-State Score

    Time frame: 3 months after disclosure counseling

    State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 of the total 40 items included in the State Score are predefined according to the validated scale.

  5. State-Trait Anxiety Index -State Score

    Time frame: 6 months after disclosure counseling

    State-Trait Anxiety Index -State Score (STAI-S, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.

  6. State-Trait Anxiety Index -Trait Score

    Time frame: 3 months after disclosure counseling

    State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.

  7. State-Trait Anxiety Index -Trait Score

    Time frame: 6 months after disclosure counseling

    State-Trait Anxiety Index -Trait Score (STAI-T, 20-item, min score 20/max score 80, higher means greater anxiety). 20 items of the full STAI scale that includes 40 items are predefined according to the validated scale.

  8. Quality of Life in Parkinson's Disease

    Time frame: 3 months after disclosure counseling

    Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.

  9. Quality of Life in Parkinson's Disease

    Time frame: 6 months after disclosure counseling

    Parkinsons disease quality of life scale- 39 (PDQ39). The PDQ-39 is a disease-specific health status measure that assess multiple dimensions of daily living. It is a validated, self-report measure for people with PD. Score range is from 0-100, with higher scores indicating a worse quality of life.

  10. Test-Related Distress

    Time frame: 6 months after disclosure counseling

    Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: GET-VIRTUAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2020
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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