Clinical Trial

Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)

Study acronym: CARE-FH
Enrolling by Invitation
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Summary
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-03-08; most recent amendment 2025-12-18.
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-02-06
Trial Details
NCT Number NCT05284513
Lead Sponsor Geisinger Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Familial Hypercholesterolemia
Enrollment 532 participants
Start Date 2022-09-09
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-22