A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome
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: Comprehensive Self-Management Program, Usual Care.
- Кому может быть актуально
- Состояния в реестре: Irritable Bowel Syndrome. Базовые параметры: 20 лет — 70 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Pilot Randomized Controlled Trial of a Taiwanese Version of a Comprehensive Self-Management Program for Adults With Irritable Bowel Syndrome
Обзор
This pilot randomized controlled trial will evaluate the feasibility, acceptability, and preliminary effects of a Taiwanese version of a comprehensive self-management program for adults with irritable bowel syndrome. Participants will be randomized to the self-management program or usual care. Outcomes will be assessed at baseline, immediately after the intervention, and three months after the intervention.
Подробное описание
The study will enroll adults with irritable bowel syndrome and randomize participants in a 2:1 ratio to an 8-session comprehensive self-management program or usual care. The program includes irritable bowel syndrome education, symptom monitoring, relaxation practice, cognitive strategies, dietary self-management, sleep-related content, problem solving, and daily-life symptom management. The pilot trial will assess recruitment, retention, intervention adherence, acceptability, satisfaction, and preliminary changes in symptom-related outcomes.
Вмешательства
- Поведенческое Comprehensive Self-Management Program
Participants assigned to the intervention group will receive an 8-session comprehensive self-management program over approximately 8 weeks. The program includes irritable bowel syndrome education, symptom monitoring, relaxation practice, cognitive strategies, dietary self-management, sleep-related content, problem solving, and daily-life symptom management. - Другое Usual Care
Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
Первичные конечные точки
- Proportion of Participants Who Complete the 3-Month Follow-Up Assessment [Срок оценки: From enrollment to 3 months post-intervention]
- Proportion of Intervention Sessions Completed [Срок оценки: From Week 1 to Week 8]
- Mean Acceptability Score Immediately Post-Intervention [Срок оценки: Immediately post-intervention]
- Proportion of Participants With Complete Questionnaire Data [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
Вторичные конечные точки (12)
- Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Percentage of Days With Moderate to Very Severe Gastrointestinal Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Fatigue T-Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance T-Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Anxiety T-Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Visceral Sensitivity Index Score Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Change From Baseline in Work Productivity and Activity Impairment Percentage Immediately Post-Intervention and at 3 Months Post-Intervention [Срок оценки: Baseline, immediately post-intervention, and 3 months post-intervention]
- Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention [Срок оценки: 3 months post-intervention]
- Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention [Срок оценки: Baseline and immediately post-intervention]
- Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention [Срок оценки: Baseline and immediately post-intervention]
Критерии участия
Inclusion Criteria:Adults aged 20 to 70 years
- Meets Rome criteria for irritable bowel syndrome
- Has a healthcare provider diagnosis of irritable bowel syndrome
- Able to read and speak Mandarin
- Willing to provide informed consent and participate in study procedures
Критерии исключения
- Pregnant or breastfeeding
- Poorly controlled mental health problems, including history of psychosis, bipolar disorder, drug or alcohol abuse or dependence, or suicide attempt within the past 2 years unless explained by significant loss
- Surgery or hospitalization within the past month
- Unable to complete study questionnaires or study procedures
- Unable to complete study questionnaires or study procedures -
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07693907 · A202305137-CSMT-RCT