GEnetic Counseling Through Virtual Visits in Parkinson's Disease (GET-VIRTUAL)

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University of Pennsylvania

Status

Completed

Conditions

Parkinson Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04527146
PCPM (Other Identifier)
843748

Details and patient eligibility

About

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

Full 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.

Enrollment

320 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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
  • MoCA < 21, or a prior diagnosis of dementia during the screening phase

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

320 participants in 4 patient groups

IMAGINE-PD/Virtual
Experimental group
Description:
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.
Treatment:
Other: IMAGINE-PD
Other: Virtual genetic counseling
IMAGINE-PD/Telephone
Experimental group
Description:
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.
Treatment:
Other: IMAGINE-PD
Other: Telephone genetic counseling
Virtual/Telephone
Experimental group
Description:
Pre-test genetic counseling virtual visit with a genetic counselor. Genetic results disclosure via telephone with a genetic counselor.
Treatment:
Other: Telephone genetic counseling
Other: Virtual genetic counseling
Virtual/Virtual
Active Comparator group
Description:
Pre-test genetic counseling and genetic results disclosure via virtual visit with a genetic counselor.
Treatment:
Other: Virtual genetic counseling

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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