Multicomponent Intervention Study- Blood Donors With High Cholesterol

Официальное название

Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Difference in change in LDL cholesterol levels from baseline to 6 months [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (4)

• Difference in 6 month LDL-C values between the two treatment arms [Срок оценки: 6 months]
• Proportion of participants prescribed high-intensity statin therapy [Срок оценки: 6 months]
• Proportion of participants prescribed any statin therapy [Срок оценки: 6 months]
• Difference in participants' knowledge regarding FH at the end of study [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
• Age 18 to 75 years

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• UT Southwestern Medical Center — Dallas

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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