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Multicomponent Intervention Study for Blood Donors With High Cholesterol

This study is for blood donors who have high cholesterol, specifically those with Familial Hypercholesterolemia (FH), a genetic condition causing high cholesterol. It aims to improve how high cholesterol is treated in these individuals. The study compares two approaches: one group receives standard notification about their high cholesterol from Carter BloodCare, while the other group receives an "Implementation Strategy Bundle." This bundle includes various communications about high cholesterol and its treatment, a website with resources, and an optional care navigator. Resources for your primary care provider will also be shared. The main goal is to see if the bundle helps lower LDL cholesterol levels (often called "bad" cholesterol) after 6 months. You can join if you are a blood donor with high cholesterol, aged 18 to 75, and not currently taking cholesterol-lowering medication or pregnant. The study is currently unclear on its recruitment status.

Study design
This is a randomized study with two groups. One group receives standard care, and the other receives the intervention bundle. The study plans to enroll 100 participants.
What's involved
You would have a screening visit with a blood and urine sample. There will be a 3-month phone call and a virtual visit at 6 months for a blood sample and surveys.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 6 months after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05693701

Multicomponent Intervention Study- Blood Donors With High Cholesterol

Recruiting
NAAges 18–75InterventionalPrevention
University of Texas Southwestern Medical Center
~100 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Implementation Strategy BundleUsual care notification

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in change in LDL cholesterol levels from baseline to 6 months
Measured over Baseline, 6 months

Conditions

Lipid Metabolism Disorder

Explore related trials

Hyperlipoproteinemia, Type IIa

NCT05693701

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UT Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amit Khera, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Amit Khera, MD
[email protected]
214.645.7500
Email the study team

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Eligibility criteria

Inclusion

Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
Age 18 to 75 years

Exclusion

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)

What this trial measures

  • Difference in change in LDL cholesterol levels from baseline to 6 monthsBaseline, 6 months

    This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months