Status:
UNKNOWN
Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Louisiana Public Health Institute
Conditions:
Congenital Heart Disease
Comorbidities and Coexisting Conditions
Eligibility:
All Genders
18+ years
Brief Summary
Congenital heart defects (CHDs) are a heterogeneous group of rare diseases of varying severity, each diagnosis with its unique set of co-morbidities. In addition to the heterogeneity, perhaps the grea...
Detailed Description
ACHD Surveillance Program/Observational Cohort (Aim 1 and Aim 2): To investigate the first two aims of this proposal, the study investigators will design and analyze an observational cohort of subject...
Eligibility Criteria
Inclusion
- For Aims 1 \& 2, participants will be deemed eligible to participate if they meet the following criteria:
- Age greater than or equal to 18 years at the time of initial data query
- Diagnosis of Congenital Heart Disease with at least one inpatient, outpatient, or emergency room visit within 8 years prior to the time of the initial data query
- Retrospective data available for 1-3 years prior to initial data query
- For Aim 3, participants will be deemed eligible to participate if they meet the following criteria:
- Age greater than or equal to18 years at the time of initial data query
- Diagnosis of Congenital Heart Disease with at least one inpatient, outpatient, or emergency room visit within 6 years prior to the time of the initial data query
- Contact Information (email, address, and/or phone number)
- Email access through internet connected device or smartphone (Android or iOS)
- Can read/write English well enough to fill out on-line surveys
Exclusion
- Age \< 18 years
- No Congenital Heart Disease (as classified by ICD9/10 codes)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT05185232
Start Date
April 1 2022
End Date
June 30 2024
Last Update
January 11 2022
Active Locations (16)
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1
University of California
San Francisco, California, United States, 94118
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
4
University of Miami
Coral Gables, Florida, United States, 33124