Celiac Disease in Childhood-Adulthood Transition
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: CeliCAT form.
- Кому может быть актуально
- Состояния в реестре: Celiac Disease, Celiac Disease in Children, Transition of Care, Follow-up. Базовые параметры: 13 лет — 19 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
- Финляндия
- 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
Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
Обзор
Aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.
Подробное описание
Celiac disease is one of the most common chronic gastrointestinal diseases affecting 1-3% of population worldwide. It is treated with life-long and strict gluten-free diet. When dietary treatment is successful, prognosis of pediatric patients seems to be excellent whereas ongoing predisposition to gluten may increase the risk even to permanent complications. However, gluten-free diet may cause burden and restrictions in everyday life impairing quality of life. Regular follow-up is recommended to support the treatment and to detect early possible comorbidities and complications, but, in practice, patients are often lost to follow-up. Studies about the significance of follow-up and its optimal implementation are scarce. Pediatric patients form a special group here as they may not even remember the reason for the diagnosis if it was set in early childhood, and the education about the disease and its treatment are often given primarily to the caregivers. Responsibility of the treatment shifts to patients themselves in adolescence at the same time with other significant changes in life and they have more often challenges with gluten-free diet than other patients. Despite this, studies about the transition from pediatrics to adult-care are very few.
This study evaluates 13-19 years old patients diagnosed with celiac disease in childhood (\<16 years of age) and compares them to adolescents without celiac disease in selected variables. Study focuses on healthcare follow-up practices and pilot a CeliCAT transition form in a randomized, controlled study design. The main hypothesis is that structured follow-up and transition of pediatric patients to adult care predicts better health, quality of life and adherence to the dietary treatment later in life. Data is collected with physical examination, questionnaires and with blood and urine samples. Follow-up is arranged at one and three years from the first visit.
Вмешательства
- Другое CeliCAT form
Systematic summary to support transition
Первичные конечные точки
- Adherence to a gluten-free diet [Срок оценки: At the onset of the study]
- Change in adherence to a gluten-free diet [Срок оценки: After 1 and 3 years]
- Transition readiness [Срок оценки: At the onset of the study]
- Change in transition readiness [Срок оценки: After 1 and 3 years]
Вторичные конечные точки (9)
- General health and health concerns [Срок оценки: At the onset of the study]
- Change in general health and health concerns [Срок оценки: After 1 and 3 years]
- Symptoms [Срок оценки: At the onset of the study]
- Change in symptoms [Срок оценки: After 1 and 3 years]
- Quality of life [Срок оценки: At the onset of the study]
- Change in quality of life [Срок оценки: After 1 and 3 years]
- Costs [Срок оценки: At the onset of the study]
- Abnormalities in follow-up laboratory evaluations [Срок оценки: At the onset of the study]
- Abnormalities in physical examination [Срок оценки: At the onset of the study]
Критерии участия
Критерии включения
- verified celiac disease diagnosis in childhood (<16 years of age)
- age 13-19 years at recruitment
- Finnish-speaking
Критерии исключения
- disease or condition preventing the completing of the study questionnaire
Inclusion criteria for controls
- no celiac disease diagnosis
- age 13-19 years at recruitment
- Finnish-speaking
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Финляндия · 5 центров
- Kuopio University Hospital — Kuopio
- South Karelia Central Hospital — Lappeenranta
- Seinäjoki Central Hospital — Seinäjoki
- Tampere Celiac Disease Research Center, Tampere University — Tampere
- Turku University Hospital — Turku
Идентификаторы
NCT: NCT05084937 · R20068