Multicomponent Intervention Study- Blood Donors With High Cholesterol (DONATE-FH)

The University of Texas System (UT)

Status: Enrolling

Conditions: Lipid Metabolism Disorder

Treatments: Other: Usual care notification; Behavioral: Implementation Strategy Bundle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05693701

1R61HL161753-01 (U.S. NIH Grant/Contract)

STU-2020-1366

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group (Usual care)

Other group

Description:

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

Treatment:

Other: Usual care notification

Intervention Group (Implementation strategy bundle)

Experimental group

Description:

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

Treatment:

Behavioral: Implementation Strategy Bundle

Other: Usual care notification