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Идёт набор NCT07478887

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

Без фазы С лечением Cardiovascular Risk LDL-C Lipids Digital Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Corrie Lipids Digital Health Program.
Кому может быть актуально
Состояния в реестре: Cardiovascular Risk, LDL-C, Lipids, Digital Health. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement

Обзор

The overall objective is to evaluate the effectiveness and implementation of the Corrie Lipids Program, a comprehensive digital health initiative designed to address critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows. Researchers plan to assess this multicenter digital health initiative in approximately 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study will examine whether the program improves LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring, while also identifying barriers and facilitators to implementation across sites.

Вмешательства

  • Устройство Corrie Lipids Digital Health Program
    The Corrie Lipids Program is a digital health initiative for adults with uncontrolled LDL-C and high ASCVD risk. It includes a smartphone app for LDL-C tracking, medication reminders, and education, along with clinician education and support to improve guideline-directed lipid management.

Первичные конечные точки

  • Percentage of participants achieving guideline-based LDL-C goals [Срок оценки: 6 months, 12 months]
  • Percentage of participants who download and engage with the Corrie app [Срок оценки: 6 months]
Вторичные конечные точки (4)
  • Percentage of patients prescribed statin and non-statin therapies [Срок оценки: 12 months]
  • Percentage of patients ordered an LDL-C test [Срок оценки: 12 months]
  • Percentage of clinicians utilizing the program for patients [Срок оценки: 12 months]
  • Percentage of patients utilizing the app [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Uncontrolled LDL-C per AHA/ACC guidelines
  • At least 1 major cardiovascular risk factor, including: high risk for ASCVD (individuals who meet criteria for Lipid-Lowering Therapy (LLT) based on ASCVD risk assessment using the most up-to-date guidelines), known ASCVD or subclinical ASCVD based on imaging, clinically diagnosed familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, history of statin-associated side effects
  • Has a primary care physician and/or cardiologist who can prescribe lipid therapy
  • Owns a smartphone and agrees to the End User License Agreement to use the digital health app
  • Provided informed consent before initiation of study-specific activities

Критерии исключения

  • Motor, cognitive, auditory, or visual impairment limiting technology use
  • Does not speak English
  • Malignancy (except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ within the previous 5 years)
  • Pregnancy (positive pregnancy test, highly sensitive urine or serum), plan to become pregnant or donate eggs, breastfeeding or plan to breastfeed
  • Likely to not be available to comply with all required study procedures to the best of the patient's and investigator's knowledge
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Johns Hopkins University School of Medicine — Baltimore

Публикации

  • Peng AW, Plott CF, Zahid S, Kassamali AA, Jones LK, Campbell-Salome G, Davis E, Head L, Kalich BA, Spitz JA, Farbaniec M, Schott SL, Martin SS, Marvel FA. Rationale and design of the Corrie Lipids Program: Impact of a digital health-enabled implementation initiative to improve lipid management. Am Heart J. 2026 Aug;298:107440. doi: 10.1016/j.ahj.2026.107440. Epub 2026 Apr 2. PMID 41935556

Идентификаторы

NCT: NCT07478887 · IRB00476278

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗