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Набор по приглашению NCT06837064

Efficacy of Chatbot for Irritable Bowel Syndrome (IBS) Patients

Без фазы С лечением Irritable Bowel Syndrome Irritable Bowel Syndrome - Constipation Irritable Bowel Syndrome - Diarrhoea Irritable Bowel Syndrome - Mixed

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: Chatbot supporting system.
Кому может быть актуально
Состояния в реестре: Irritable Bowel Syndrome, Irritable Bowel Syndrome - Constipation, Irritable Bowel Syndrome - Diarrhoea, Irritable Bowel Syndrome - Mixed. 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
Россия
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

Evaluation of the Efficacy of Chatbot-based Automated Support System for Patients with Irritable Bowel Syndrome (IBS)

Обзор

The goal of this clinical trial is to evaluate the efficacy of an automated chatbot system in improving quality of life, reducing depression and anxiety, and decreasing visceral sensitivity in patients with Irritable Bowel Syndrome. The main research question is: Is an automated chatbot as effective for patients with IBS as standard care? Participants will be asked to complete online surveys to assess quality of life, symptoms of depression and anxiety, and visceral sensitivity before and after the intervention.

Подробное описание

The study consists of three stages:

Stage 1: Patients with Irritable Bowel Syndrome (IBS) who meet the eligibility criteria will be invited to participate in the study. After providing written informed consent, all participants will be asked to complete a set of questionnaires to assess various parameters:

1. Irritable Bowel Syndrome Quality of Life (IBS-QOL); 2. Quality of Life - Short Form-36 (SF-36); 3. Symptoms of Anxiety and/or Depression - Hospital Anxiety and Depression Scale (HADS); 4. State and Trait Anxiety Levels - State-Trait Anxiety Inventory (STAI); 5. Visceral Sensitivity - Visceral Sensitivity Index (VSI);

Stage 2: Participants will be randomized into one of two groups: a chatbot group (intervention) and a standard care group (control). Prior to enrollment, both groups will receive a consultation with a gastroenterologist providing information on lifestyle, diet, and treatment. The intervention group will receive the access to a chatbot.

At the fourth and eighth week of follow-up participants in both groups will be asked to re-complete the set of questionnaires (IBS-QOL, SF-36, HADS, STAI, VSI). No routine gastroenterologist consultations will be scheduled during the follow-up period.

Stage 3: Results from the questionnaires will be analyzed and used to formulate conclusions.

Вмешательства

  • Устройство Chatbot supporting system
    The intervention tool is the automated chatbot supporting system, which contains: A) educational information (therapeutic education and psychoeducation); B) symptom monitoring (stool quality and frequency, assessment of mood, sleep quality, physical activity, and dietary adherence on a scale of 0 to 10); C) behavioral distraction techniques, and body tension reduction techniques.

Первичные конечные точки

  • Change the Health-related quality of life in IBS [Срок оценки: 8 weeks]
  • Change the Health-related quality of life in IBS [Срок оценки: 8 weeks]
Вторичные конечные точки (3)
  • Change psychological well-being of patients with IBS measured by HADS [Срок оценки: 8 weeks]
  • Change psychological well-being of patients with IBD measured by VSI [Срок оценки: 8 weeks]
  • Change psychological well-being of patients with IBS measured by STAI [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Adults ≥18 years;
  • Diagnosed with IBS;
  • Signed informed consent.

Критерии исключения

  • Age under 18 years;
  • Pregnant individuals;
  • Patients with cognitive or sensory impairments that hinder understanding of questions in surveys, scales, or instruments used in the study;
  • Patients unable to use a chatbot;
  • Patients currently participating in any other clinical trial or experimental study;
  • Patients with psychotic symptoms;
  • Patients with other conditions that may influence the endpoints of the current study.

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Россия · 1 центр
  • Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of th — Moscow

Идентификаторы

NCT: NCT06837064 · 2025-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗