The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
370
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.
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.
University of Pennsylvania Parkinsons Disease and Movement Disorders Center
Philadelphia, Pennsylvania, United States
Genetics Knowledge
Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
Time frame: 4 weeks after pre-testing education/counseling
Genetic Counseling Satisfaction (Post-Test)
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Time frame: Immediately after disclosure counseling
Test-Related Distress
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Time frame: 3 months after disclosure counseling
Genetic Counseling Satisfaction (Pre-Test)
Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
Time frame: Immediately after pre-test education/counseling
Depression
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Time frame: 3 months after disclosure counseling
Depression
Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Time frame: 6 months after disclosure counseling
State-Trait Anxiety Index-State Score
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 3 months after disclosure counseling
State-Trait Anxiety Index -State Score
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.
Time frame: 6 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
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.
Time frame: 3 months after disclosure counseling
State-Trait Anxiety Index -Trait Score
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.
Time frame: 6 months after disclosure counseling
Quality of Life in Parkinson's Disease
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.
Time frame: 3 months after disclosure counseling
Quality of Life in Parkinson's Disease
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.
Time frame: 6 months after disclosure counseling
Test-Related Distress
Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Time frame: 6 months after disclosure counseling