Duchenne Electronic Health Record Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Duchenne Registry

About this trial

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

Qualifiers

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

Disqualifiers

Individuals with other forms of muscular dystrophy

Individuals who do not provide consent

Trial design

Treatments tested in this trial

  • Observational study with patients who may be treated with various disease-modifying therapies

Treatment groups

No treatment groups listed

Sponsors and collaborators

The Duchenne Registry

Lead sponsor

Parent Project Muscular Dystrophy

Collaborator