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NCT05693701NARecruiting

Multicomponent Intervention Study- Blood Donors With High Cholesterol

University of Texas Southwestern Medical Center

Start Date

2/27/2023

Completion Date

4/30/2027

Summary

The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).

Detailed Description

This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site. Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C. Follow-up phone call: At 3 months post-randomization, participants in both arms will be briefly contacted by phone by the Research Assistant to thank them for their participation and to answer any study related questions. End of study 6 month visit. Participants will engage in a virtual visit for end of study procedures. At this follow-up visit, the Research Assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat LDL-C measurement. The Research Assistant will administer an electronic survey and knowledge questionnaires. Additional clinical visits as desired by the participants' physicians will be allowed at their discretion.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria * Age 18 to 75 years Exclusion Criteria: * Currently taking medication to lower cholesterol * Taking any medication that can interact with statins * Pregnancy * Identified secondary cause of elevated lipids * Chronic liver disease or significantly elevated liver function tests (\> 3 times upper limit)

Interventions

BEHAVIORAL

Implementation Strategy Bundle

OTHER

Usual care notification

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Conditions

Lipid Metabolism Disorder

Locations

UT Southwestern Medical Center

Dallas, Texas 75390

United States