Overcoming Barriers to Accessing Genetic Medicine

Genetic Disease Clinical Trial

Official title:

Investigations of Barriers and Methods to Overcome Barriers to Access Genetic Medicine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05064241
• Other study ID #: P00039779
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn about patient barriers to accessing genetic medicine, we will analyze anonymous posts from a membership-based online community [Inspire.com], and investigate how these barriers differ for various populations. We will then test whether these barriers can be addressed by providing online access to a genetic counselor to answer patient questions for one group of patients (virtual advisory board group) and compare to that of a control group who does not have access to a genetic counselor (virtual peer-to-peer board group).

Description:

Genomic medicine has the potential to advance diagnoses, predict risk, support prevention efforts, and inform treatment decision-making. Though technologies for measuring genetic variants have improved and become more cost-effective, clinical integration of genomic medicine has been surprisingly slow. For genomic medicine to be successfully implemented across specialties and across demographics, the systemic barriers that patients experience need to be identified and addressed.

Online health support is becoming an increasingly important part of healthcare as more patients use digital health networks. In the first part of this study, an analysis of online communication in a membership-based online support community [Inspire.com] will identify systemic, structural and individual barriers to accessing genomic medicine. A genetic counselor will be informed to these results and will be part of the intervention arm of the study.

To assess the extent to which online health networks can directly help genomic medicine implementation, participants will join one of two Virtual Discussion Boards (a Virtual Advisory Board and a Virtual Peer-to-Peer Discussion Board). In the intervention arm, the Virtual Advisory Board will have a genetic counselor answer patient questions online about genomic medicine once every week for a period of three months. In the control arm, participants will answer and comment on each others' questions in the Virtual Peer-to-Peer Discussion Board. We hypothesize that after six months, patients who participate in the Virtual Advisory Board are more likely to self-report receiving genomic medicine than those in the control arm. After completion of the study, participants in the Peer-to-Peer Discussion Board, we will give online access to the genetic counselor to answer any questions

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2025
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Member of Inspire.com Genetic disease Genetic predisposition to disease -

Exclusion Criteria:

Not member of Inspire.com No genetic disease No genetic predisposition to disease

-

Related Conditions & MeSH terms

• Genetic Disease
• Genetic Diseases, Inborn
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Other:
• Access to Genetic Counselor for answering questions
A genetic counselor answers questions posed by participants in the intervention arm on how to access genetic medicine. At the end of the study, the number of participants who were able to access genetic medicine will be assessed

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative self-report of referrals for clinical genetic services	Percentage of participants with self-report of referrals for clinical genetic services	6 months
Secondary	Qualitative self-report of specific barriers to the participant accessing genomic medicine	The ability for a participant to articulate the barriers to them accessing genetic medicine	6 months
Secondary	Self-report of specific behaviors to overcome barriers to accessing genetic medicine	Qualitative assessment of ability for a participant to self-report performing behaviors to overcome barriers to accessing genetic medicine.	6 months