Clinical trial NCT04527146: GEnetic Counseling Through Virtual Visits in Parkinson's Disease
Official title: GEnetic Counseling Through VIRTUAL Visits in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 370
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Genetics Knowledge
timeFrame: 4 weeks after pre-testing education/counseling
measure: Genetic Counseling Satisfaction (Post-Test)
timeFrame: Immediately after disclosure counseling
measure: Test-Related Distress
timeFrame: 3 months after disclosure counseling
Secondary outcomes:
measure: Genetic Counseling Satisfaction (Pre-Test)
timeFrame: Immediately after pre-test education/counseling
measure: Depression
timeFrame: 3 months after disclosure counseling
measure: Depression
timeFrame: 6 months after disclosure counseling
measure: State-Trait Anxiety Index-State Score
timeFrame: 3 months after disclosure counseling
measure: State-Trait Anxiety Index -State Score
timeFrame: 6 months after disclosure counseling
measure: State-Trait Anxiety Index -Trait Score
timeFrame: 3 months after disclosure counseling
measure: State-Trait Anxiety Index -Trait Score
timeFrame: 6 months after disclosure counseling
measure: Quality of Life in Parkinson's Disease
timeFrame: 3 months after disclosure counseling
measure: Quality of Life in Parkinson's Disease
timeFrame: 6 months after disclosure counseling
measure: Test-Related Distress
timeFrame: 6 months after disclosure counseling
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Parkinsons Disease and Movement Disorders Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Thomas F Tropea, DO
role: PRINCIPAL_INVESTIGATOR
References: