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NCT Number: NCT05693701

Multicomponent Intervention Study- Blood Donors With High Cholesterol

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Amit Khera, MD

CONTACT

[email protected]

Amit Khera, MD

PRINCIPAL_INVESTIGATOR

Lakeisha Cade

CONTACT

[email protected]

214.648.2878

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Implementation strategy bundle

Behavioral

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

Other

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 outcomes

  1. Difference in change in LDL cholesterol levels from baseline to 6 months

    Time frame: Baseline, 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

Secondary outcomes

  1. Difference in 6 month LDL-C values between the two treatment arms

    Time frame: 6 months

    This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples.

  2. Proportion of participants prescribed high-intensity statin therapy

    Time frame: 6 months

    Proportion of participants prescribed high-intensity statin therapy will be calculated as the number of patients who were prescribed high-intensity statin therapy in each arm divided by the total number of participants analyzed in each arm

  3. Proportion of participants prescribed any statin therapy

    Time frame: 6 months

    Proportion of participants prescribed any statin therapy will be calculated as the number of patients who were prescribed any statin therapy in each arm divided by the total number of participants analyzed in each arm

  4. Difference in participants' knowledge regarding FH at the end of study

    Time frame: 6 months

    Difference in participant's knowledge regarding FH at 6 months is measured using a validated FH knowledge survey where higher scores indicate greater knowledge. Comparisons between the two study arms will be made.

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Khera, MD

CONTACT

[email protected]

214.645.7500

Lakeisha Cade

CONTACT

[email protected]

214.648.2878

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

Acronym: DONATE-FH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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