Multicomponent Intervention Study- Blood Donors With High Cholesterol

Last updated: March 2, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyslipidemia

Lysosomal Acid Lipase Deficiency (Lal)

High Cholesterol (Hyperlipidemia)

Treatment

Implementation Strategy Bundle

Usual care notification

Clinical Study ID

NCT05693701
STU-2020-1366
1R61HL161753-01
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria

  • Age 18 to 75 years

Exclusion

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 timesupper limit)

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Implementation Strategy Bundle
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.