Overcoming Barriers to Accessing Genetic Medicine
Primary Purpose
Genetic Disease, Genetic Predisposition
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Access to Genetic Counselor for answering questions
Sponsored by
About this trial
This is an interventional health services research trial for Genetic Disease
Eligibility Criteria
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
-
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Advisory Board
Virtual Peer-to-Peer Discussion Board
Arm Description
Participants have access to a genetic counselor to answer their questions on accessing genetic medicine.
Participants answer each others' questions on the topic of accessing genetic medicine.
Outcomes
Primary Outcome Measures
Qualitative self-report of referrals for clinical genetic services
Percentage of participants with self-report of referrals for clinical genetic services
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT05064241
First Posted
September 22, 2021
Last Updated
August 9, 2023
Sponsor
Boston Children's Hospital
Collaborators
National Human Genome Research Institute (NHGRI)
1. Study Identification
Unique Protocol Identification Number
NCT05064241
Brief Title
Overcoming Barriers to Accessing Genetic Medicine
Official Title
Investigations of Barriers and Methods to Overcome Barriers to Access Genetic Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Human Genome Research Institute (NHGRI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disease, Genetic Predisposition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group has access to a genetic counselor answering their questions, another group has peer-to-peer conversation. However, at the end of the study, the genetic counselor will answer the questions asked in the peer-to-peer discussion board.
Masking
Participant
Masking Description
Participants will not be told which discussion board they are randomized to. However, they may possibly discover that one board has a genetic counselor, and the other does not.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Advisory Board
Arm Type
Experimental
Arm Description
Participants have access to a genetic counselor to answer their questions on accessing genetic medicine.
Arm Title
Virtual Peer-to-Peer Discussion Board
Arm Type
No Intervention
Arm Description
Participants answer each others' questions on the topic of accessing genetic medicine.
Intervention Type
Other
Intervention Name(s)
Access to Genetic Counselor for answering questions
Intervention Description
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
Primary Outcome Measure Information:
Title
Qualitative self-report of referrals for clinical genetic services
Description
Percentage of participants with self-report of referrals for clinical genetic services
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Qualitative self-report of specific barriers to the participant accessing genomic medicine
Description
The ability for a participant to articulate the barriers to them accessing genetic medicine
Time Frame
6 months
Title
Self-report of specific behaviors to overcome barriers to accessing genetic medicine
Description
Qualitative assessment of ability for a participant to self-report performing behaviors to overcome barriers to accessing genetic medicine.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will share aggregated and de-identified data as requested in accordance with our IRB protocol.
Learn more about this trial
Overcoming Barriers to Accessing Genetic Medicine
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