Development of the SC-IBD Self-Care Measurement Scale
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: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease. 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
- Италия
- 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
Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting
Обзор
This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.
Подробное описание
This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.
In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.
The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.
The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.
Первичные конечные точки
- Psychometric Validation of the SC-IBD Scale [Срок оценки: Baseline to 3 months]
Вторичные конечные точки (6)
- Qualitative Themes of Self-Care in Patients with IBD [Срок оценки: Baseline]
- Psychological Distress Measured by DASS-21 [Срок оценки: Baseline]
- Health-Related Quality of Life Assessed by SF-12 [Срок оценки: Baseline]
- Illness Perception Measured by BIPQ [Срок оценки: Baseline]
- Perceived Disease Control Measured by IBD-Control [Срок оценки: Baseline]
- Food Literacy Assessed by the Short Food Literacy Questionnaire [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Voluntary willingness to participate in the study.
- Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
- Follow-up in outpatient setting.
- Age 18 years or older.
- Ability to read and speak Italian.
- Ability to understand the study procedures.
- Signed informed consent.
Критерии исключения
- Age younger than 18 years.
- Significant cognitive impairment (e.g., dementia) that may limit participation.
- Insufficient comprehension of the Italian language.
- Severe psychiatric disorders that may compromise participation.
- Severe clinical conditions preventing participation in interviews or questionnaire completion.
- Refusal to sign the informed consent form.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Идентификаторы
NCT: NCT07494227 · 8158 - SC-IBD