Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

What this Trial Is About

Researchers are evaluating a multicomponent approach to improve cholesterol treatment in blood donors diagnosed with Familial Hypercholesterolemia (FH), a genetic condition causing high cholesterol. This randomized, two-arm trial compares usual care notification with an implementation strategy bundle to better inform and support patients and their primary care providers. The study is conducted at UT Southwestern Medical Center with recruitment through Carter BloodCare. Participants are randomly assigned to either receive standard notification about their high cholesterol from Carter BloodCare or to receive this usual care plus an implementation bundle. The bundle includes educational materials, a website with resources, and an optional care navigator to assist with cholesterol management. Those in the control group can access the intervention bundle after the study concludes. Participants will attend a screening and baseline visit where blood and urine samples are collected for LDL cholesterol testing and eligibility confirmation. At 3 months, a follow-up phone call will thank participants and answer questions. At 6 months, a virtual visit will assess adverse events, collect fasting blood samples for LDL cholesterol re-measurement, and include electronic surveys and knowledge questionnaires. Additional clinical visits can occur as directed by participants' physicians. The main outcome measured is the change in LDL cholesterol from baseline to 6 months.

Multicomponent Intervention Study- Blood Donors With High Cholesterol