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Идёт набор NCT05332639

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

Без фазы С лечением Inflammatory Bowel Diseases Crohn Disease Crohn Colitis Crohn's Ileocolitis

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: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool, Standard Crohn's Disease Education.
Кому может быть актуально
Состояния в реестре: Inflammatory Bowel Diseases, Crohn Disease, Crohn Colitis, Crohn's Ileocolitis. Базовые параметры: от 14 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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Обзор

The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.

Вмешательства

  • Поведенческое Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
    We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also displa
  • Поведенческое Standard Crohn's Disease Education
    The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well.

Первичные конечные точки

  • Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion [Срок оценки: 1.5 years and time of study completion]
Вторичные конечные точки (12)
  • Motivation to change smoking behavior [Срок оценки: 8 weeks and 6 months]
  • Motivation to change diet [Срок оценки: 8 weeks and 6 months]
  • Motivation to change physical activity [Срок оценки: 8 weeks and 6 months]
  • Change in physical activity [Срок оценки: 8 weeks and 6 months]
  • Change in fruit intake [Срок оценки: 8 weeks and 6 months]
  • Change in vegetable intake [Срок оценки: 8 weeks and 6 months]
  • Change in processed meat intake [Срок оценки: 8 weeks and 6 months]
  • Change in fiber intake [Срок оценки: 8 weeks and 6 months]
  • Change in added sugar intake [Срок оценки: 8 weeks and 6 months]
  • Change in smoking behaviors [Срок оценки: 8 weeks and 6 months]
  • Change in C-reactive protein (CRP; mg/L) [Срок оценки: 8 weeks and 6 months]
  • Change in fecal calprotectin (mcg/g) [Срок оценки: 8 weeks and 6 months]

Критерии участия

Критерии включения

  • Ability to give informed consent
  • Ability and willingness to comply with all patient visits and study-related procedures
  • Ability to understand and complete study questionnaires
  • Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)
  • Individuals greater than 14 years of age

Критерии исключения

  • Inability to provide informed consent
  • Inability to comply with all patient visits and study-related procedures
  • Inability to understand or complete study questionnaires
  • Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
  • Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Публикации

  • Colditz GA, Dart H. Commentary: 20 years online with "Your Disease Risk". Cancer Causes Control. 2021 Jan;32(1):5-11. doi: 10.1007/s10552-020-01356-3. Epub 2020 Oct 17. PMID 33068181

Идентификаторы

NCT: NCT05332639 · 2022p000905 · 1K23DK136977-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗