GEnetic Counseling Through Virtual Visits in Parkinson's Disease

Not Applicable

Completed

Conditions: Parkinson Disease

Interventions: Other: IMAGINE-PD
Other: Virtual genetic counseling
Other: Telephone genetic counseling

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IMAGINE-PD/Virtual	Virtual genetic counseling	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.
IMAGINE-PD/Telephone	IMAGINE-PD	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.
IMAGINE-PD/Virtual	IMAGINE-PD	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.
Virtual/Virtual	Virtual genetic counseling	Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.
IMAGINE-PD/Telephone	Telephone genetic counseling	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.
Virtual/Telephone	Telephone genetic counseling	Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.
Virtual/Telephone	Virtual genetic counseling	Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.

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
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.
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.
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)