Clinical trial NCT05693701: Multicomponent Intervention Study- Blood Donors With High Cholesterol
Official title: Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lipid Metabolism Disorder
Keywords: Blood Donors
High Cholesterol
LDL Cholesterol
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment assignment will be via block randomization stratified on age category in a 1:1 allocation ratio.
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference in change in LDL cholesterol levels from baseline to 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Difference in 6 month LDL-C values between the two treatment arms
timeFrame: 6 months
measure: Proportion of participants prescribed high-intensity statin therapy
timeFrame: 6 months
measure: Proportion of participants prescribed any statin therapy
timeFrame: 6 months
measure: Difference in participants' knowledge regarding FH at the end of study
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Amit Khera, MD
role: PRINCIPAL_INVESTIGATOR
References: