Multicomponent Intervention Study- Blood Donors With High Cholesterol
NCT ID: NCT05693701
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-02-27
2027-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
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.
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 75 years
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Amit Khera
PROFESSOR - Internal Medicine
Principal Investigators
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Amit Khera, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU-2020-1366
Identifier Type: -
Identifier Source: org_study_id
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