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Идёт набор NCT06916052

Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy

— Наблюдательное Outpatient Colonoscopy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Outpatient Colonoscopy. Базовые параметры: 18 лет — 80 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
Испания
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

An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy

Обзор

The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy. Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients. A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it. Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services. For that to happen, participants must have sufficient technological skills to use a smartphone.

Подробное описание

A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.

Первичные конечные точки

  • Percentage of patients scheduled colonoscopy who have an adequate bowel preparation. [Срок оценки: Day 0, (Colonoscopy Day)]
Вторичные конечные точки (12)
  • Active Patient Rate [Срок оценки: Day -14 (14 days before the colonoscopy)]
  • Patients with section completed: Treatments [Срок оценки: Day -14 (14 days before the colonoscopy)]
  • Patients with section completed: Pick up the bowel preparation [Срок оценки: Day -10 (10 days before colonoscopy)]
  • Patients with section completed: Colonoscopy Preparation Solution (laxative). [Срок оценки: Day 2 (2 days after colonoscopy)]
  • Patients with section completed: Procedure satisfaction questionnaire [Срок оценки: Day 3 (3 days after colonoscopy)]
  • Patients with section completed: Adverse Events [Срок оценки: Day 1, Day 14 and Day 30]
  • Percentage of patients with 100% of data completed [Срок оценки: Day 31 (31days after the colonoscopy)]
  • Patients who view educational materials: Pick up the laxative [Срок оценки: Day -10 (10 days before colonoscopy)]
  • Patients who view educational materials: Diet [Срок оценки: Day -4 (4 days before colonoscopy)]
  • Patients who view educational materials: Adequate preparation for a colonoscopy [Срок оценки: Day -4 (4 days before colonoscopy)]
  • Patients who view educational materials: Bring someone [Срок оценки: Day -4 (4 days before colonoscopy)]
  • Patients who view educational materials: Instructions for your colonoscopy [Срок оценки: Day -3 (3 days before colonoscopy)]

Критерии участия

Критерии включения

  • Age 18 or older.
  • Signed informed consent.
  • Patients scheduled for outpatient colonoscopy.
  • Patients able to complete the study questionnaires.
  • Patients who regularly use a smartphone

Критерии исключения

  • Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
  • Minors or elderly patients (over 80 years of age).
  • Patients with prior colorectal surgery.
  • Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
  • Inability to provide adequate informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Hospital Clínic de Barcelona — Barcelona

Идентификаторы

NCT: NCT06916052 · COLObs

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗