Genetic DiseaseNCT05064241
Overcoming Barriers to Accessing Genetic Medicine
A study testing Access to Genetic Counselor for answering questions in people with Genetic Disease and Genetic Predisposition, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Disease, Genetic Predisposition
- What is being tested?
- Access to Genetic Counselor for answering questions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Member of Inspire.com Genetic disease Genetic predisposition to disease -
Who cannot join
- Not member of Inspire.com No genetic disease No genetic predisposition to disease
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Investigations of Barriers and Methods to Overcome Barriers to Access Genetic Medicine
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).
Read the 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
- Conditions
- Genetic Disease, Genetic Predisposition
- Being tested
- Access to Genetic Counselor for answering questions
- Medical subject headings
- Genetic Diseases, Inborn, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Genetic Counselor for answering questionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual Advisory Board | Experimental | Participants have access to a genetic counselor to answer their questions on accessing genetic medicine. Receives: Other: Access to Genetic Counselor for answering questions |
| Virtual Peer-to-Peer Discussion Board | No intervention | Participants answer each others' questions on the topic of accessing genetic medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative self-report of referrals for clinical genetic services
Percentage of participants with self-report of referrals for clinical genetic services
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Apr 2023
- Primary completion30 Jul 2023
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Catherine Brownstein, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064241
- Sponsor's protocol ID
- P00039779
- Status last verified
- Jun 2024
- First submitted
- 22 Sep 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share aggregated and de-identified data as requested in accordance with our IRB protocol.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Barriers and Methods to Overcome Barriers to Access Genetic Medicine
- ClinicalTrials.gov ID
- NCT05064241
- Acronym / sponsor ID
- P00039779
- Conditions
- Genetic Disease, Genetic Predisposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Advisory Board | Experimental | Other: Access to Genetic Counselor for answering questionsParticipants have access to a genetic counselor to answer their questions on accessing genetic medicine. |
| Virtual Peer-to-Peer Discussion Board | No intervention | –Participants answer each others' questions on the topic of accessing genetic medicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member of Inspire.com Genetic disease Genetic predisposition to disease -
Key exclusion criteria (2 listed)
- Not member of Inspire.com No genetic disease No genetic predisposition to disease
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to Genetic Counselor for answering questionsA 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 | Other | Virtual Advisory Board |
Primary outcome
Qualitative self-report of referrals for clinical genetic services
Time frame: 6 months
Percentage of participants with self-report of referrals for clinical genetic services
2 secondary outcomes
Qualitative self-report of specific barriers to the participant accessing genomic medicine
Time frame: 6 months
Self-report of specific behaviors to overcome barriers to accessing genetic medicine
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. We will share aggregated and de-identified data as requested in accordance with our IRB protocol.
Related trials for Genetic Disease
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to Genetic Counselor for answering questions in people with Genetic Disease and Genetic Predisposition, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative self-report of referrals for clinical genetic services (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.