An interventional study of Implementation Strategy Bundle and Usual care notification in Lipid Metabolism Disorder, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Compared within Hypercholesterolemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lipid Metabolism Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: Usual care notification
Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)
Behavioral: Implementation Strategy Bundle · Other: Usual care notification
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.
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.
Difference in change in LDL cholesterol levels from baseline to 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
Time frame: Baseline, 6 months
Difference in 6 month LDL-C values between the two treatment arms
This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples.
Time frame: 6 months
Proportion of participants prescribed high-intensity statin therapy
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
Time frame: 6 months
Proportion of participants prescribed any statin therapy
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
Time frame: 6 months
Difference in participants' knowledge regarding FH at the end of study
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.
Time frame: 6 months
Plan to share: No
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