Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05693701

Conditions

Lipid Metabolism Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Implementation Strategy Bundle

Usual care notification

Study Details

Brief summary:

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

Conditions

Lipid Metabolism Disorder

Study ID

NCT05693701

Start date

Feb 27, 2023

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Control group (Usual care)

This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol

experimental: Intervention Group (Implementation strategy bundle)

Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)

Interventions

Implementation Strategy Bundle

Bundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated.

Usual care notification

Carter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study.

Primary outcome measure

  • Difference in change in LDL cholesterol levels from baseline to 6 months [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Amit Khera, MD

214.645.7500Amit.Khera@UTSouthwestern.edu

Lakeisha Cade

214.648.2878Lakeisha.Cade@UTSouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Lakeisha Cade

214.648.2878BloodDonorStudy@UTSouthwestern.edu

Amit Khera, MD

BloodDonorStudy@UTSouthwestern.edu

Principal Investigator:

Amit Khera, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Blood Donors
  • High Cholesterol
  • LDL Cholesterol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-03-17.