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Recruiting NCT05693701

Multicomponent Intervention Study- Blood Donors With High Cholesterol

No phase Interventional Lipid Metabolism Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation Strategy Bundle, Usual care notification.
Who it may be relevant to
Registry conditions: Lipid Metabolism Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

Overview

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.

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

  • Difference in change in LDL cholesterol levels from baseline to 6 months [Time frame: Baseline, 6 months]
Secondary outcome measures (4)
  • Difference in 6 month LDL-C values between the two treatment arms [Time frame: 6 months]
  • Proportion of participants prescribed high-intensity statin therapy [Time frame: 6 months]
  • Proportion of participants prescribed any statin therapy [Time frame: 6 months]
  • Difference in participants' knowledge regarding FH at the end of study [Time frame: 6 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • UT Southwestern Medical Center — Dallas

Identifiers

NCT: NCT05693701 · STU-2020-1366 · 1R61HL161753-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗