Идёт набор NCT07684716

Individualized Non-pharmacological Intervention for Bowel Preparation

Без фазы С лечением Bowel Preparation for 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: В протоколе указаны: Individualized bowel preparation regimen, Information-framing guidance, Standard bowel preparation guidance.
Кому может быть актуально: Состояния в реестре: Bowel Preparation for Colonoscopy. 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: Китай
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

Effect of an Individualized Non-pharmacological Intervention Based on a Predictive Model for Inadequate Bowel Preparation on Bowel Preparation Quality: a Three-arm, Prospective, Randomized Controlled Study

Обзор

Colonoscopy is essential for the early detection of colorectal cancer. However, inadequate bowel preparation remains a common challenge, associated with reduced adenoma detection rates, prolonged procedure time, and increased healthcare costs. Current individualized regimens rely largely on higher laxative dosages-an approach with limited clinical utility. Non-pharmacological interventions, including dietary modification, physical activity, and health education, are safe and tend to have better patient adherence. The effectiveness of health education depends largely on message framing. Guided by information-framing theory, we developed an individualized non-pharmacological regimen. This randomized controlled trial aims to evaluate the efficacy of this regimen in improving bowel preparation quality.

Подробное описание

A total of 339 patients are enrolled and randomly assigned in a 1:1:1 ratio to the information-framing + individualized bowel preparation (BP) group, the individualized BP group, and the control group. All patients receive oral instructions on bowel preparation. On this basis, the control group receives a standard BP regimen and written educational materials; the individualized BP group is assessed using a risk prediction model for inadequate bowel preparation, with the results disclosed to the patients. Those with a risk score ≥3.25 receive an enhanced BP regimen, while those with a risk score \<3.25 receive the standard BP regimen, and all patients in this group receive illustrated educational materials. In the information-framing + individualized BP group, educational materials are further tailored according to the information framework theory. Specifically, patients with a risk score ≥3.25 receive loss-framed materials emphasizing the harms of non-adherence, whereas those with a score \<3.25 receive gain-framed materials highlighting the benefits of adherence. On the day of the colonoscopy, patients' willingness to undergo a repeat colonoscopy and the occurrence of adverse events are recorded in the waiting area. Patients also complete the Bowel Preparation Adherence Behavior Assessment Scale and the Treatment Self-Regulation Questionnaire. Bowel preparation quality is evaluated by endoscopists blinded to group allocation using the Boston Bowel Preparation Scale (BBPS), and polyp/adenoma detection rates are also recorded.

Вмешательства

Другое Individualized bowel preparation regimen
Patients receive verbal instructions and printed illustrated bowel preparation educational material. Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day. After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes. Patients with a score \< 3.
Другое Information-framing guidance
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score \< 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
Другое Standard bowel preparation guidance
Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.

Первичные конечные точки

Bowel preparation quality [Срок оценки: Assessed by the endoscopist during colonoscopy procedure]

Вторичные конечные точки (4)

Incidence of bowel preparation-related adverse events [Срок оценки: Recorded during the waiting period prior to colonoscopy procedure]
Polyp/adenoma detection rate [Срок оценки: Assessed by the endoscopist during colonoscopy procedure]
Compliance of bowel preparation [Срок оценки: Assessed during the waiting period prior to colonoscopy procedure]
Willingness to undergo colonoscopy again (yes/no) [Срок оценки: Assessed during the waiting period prior to colonoscopy procedure]

Критерии участия

Критерии включения

age ≥ 18 years;
outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
able to understand the study and provide written informed consent.