NCT07609394 Duchenne Electronic Health Record Study
| NCT ID | NCT07609394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Duchenne Registry |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2022-12-01 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to collect retrospective and prospective, long-term data of patients with dystrophinopathy (including Duchenne, Becker, and female carriers) through electronic transfer. At select clinics across the United States, electronic health record (EHR) data from consented patients will be pushed into PPMD's Duchenne Outcomes Research Interchange (the Interchange), where the EHR data can be combined with patient-reported data from The Duchenne Registry. By combining this data in a central hub, we will gain a more complete picture of Duchenne and Becker muscular dystrophy, allowing researchers and clinicians to develop treatments faster and to improve and refine the standards of care for Duchenne and Becker. The ultimate goal is to optimize function, quality of life, and survival of Duchenne and Becker patients. EHR data collected will be fully identifiable retrospective data for core clinical data elements going back ten years (as available) from the date of consent; going back one year for retrospective clinical notes from the date of consent; and prospectively collecting both core clinical data elements and clinical notes. Information collected will align with the FHIR U.S. core data elements, also known as the Common Clinical Data Set. PPMD partnered with Prometheus Research (an IQVIA company), an industry leader in health data informatics, to launch both the EHR Study and the Interchange. All data is stored securely and in accordance with strict industry standards and patient privacy laws. Participation in the EHR data extraction is voluntary, and a patient can withdraw consent at any time.
Eligibility Criteria
Inclusion Criteria: * Duchenne or Becker muscular dystrophy or female carrier * Must be a patient at an institution that has an established EHR integration set up with PPMD's Interchange * Must provide consent to have their EHR data pushed to the Interchange and linked to existing Registry data, if applicable Exclusion Criteria: * Individuals with other forms of muscular dystrophy * Individuals who do not provide consent Individuals with Duchenne/Becker who have severe mobility/strength issues need to provide consent and participate with assistance from a caregiver. Adults with communication impairments and/or intellectual disabilities (considered the "decisionally impaired" group for purposes of this study) will be able to consent with the assistance of the adults who are designated Legally Authorized Representative (LAR). Without assistance, this group will be excluded from participation because the consent process.
Contact & Investigator
Ann Martin, MS, CGC
PRINCIPAL INVESTIGATOR
Parent Project Muscular Dystrophy
Frequently Asked Questions
Who can join the NCT07609394 clinical trial?
This trial is open to participants of all sexes, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609394 currently recruiting?
Yes, NCT07609394 is actively recruiting participants. Contact the research team at megan@parentprojectmd.org for enrollment information.
Where is the NCT07609394 trial being conducted?
This trial is being conducted at Little Rock, United States, Sacramento, United States, Aurora, United States, New Haven, United States and 6 additional locations.
Who is sponsoring the NCT07609394 clinical trial?
NCT07609394 is sponsored by The Duchenne Registry. The principal investigator is Ann Martin, MS, CGC at Parent Project Muscular Dystrophy. The trial plans to enroll 2,500 participants.