GEnetic Counseling Through Virtual Visits in Parkinson's Disease
- Conditions
- Parkinson Disease
- Registration Number
- NCT04527146
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
The research study is being conducted to compare methods of virtual genetic counseling for people with Parkinson's disease.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Test-Related Distress 3 months after disclosure counseling Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Genetics Knowledge 4 weeks after pre-testing education/counseling Genetics Knowledge Scale (20-question true/false questionnaire, score range 0-20, higher scores mean greater knowledge)
Genetic Counseling Satisfaction (Post-Test) Immediately after disclosure counseling Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
- Secondary Outcome Measures
Name Time Method State-Trait Anxiety Index -Trait Score 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.
Depression 6 months after disclosure counseling Geriatric Depression Scale (GDS, 15-item score range 0-15, higher means greater depression)
Genetic Counseling Satisfaction (Pre-Test) Immediately after pre-test education/counseling Genetic Counseling Satisfaction Scale (GCSS) (6-item scale, score range 6-30, higher scores mean greater satisfaction)
State-Trait Anxiety Index-State Score 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.
State-Trait Anxiety Index -State Score 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.
Quality of Life in Parkinson's Disease 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.
Test-Related Distress 6 months after disclosure counseling Revised Impact of Events Scale (22-item, score range 0-88, higher scores mean greater event-related distress)
Trial Locations
- Locations (1)
University of Pennsylvania Parkinsons Disease and Movement Disorders Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Parkinsons Disease and Movement Disorders Center🇺🇸Philadelphia, Pennsylvania, United States