- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07648108
Evaluation of a Day Hospital Program for Adolescents and Young Adults With Eating Disorders (UDJ-TCA)
Evaluation of the Contribution of a Specialized Day Hospital for Adolescents and Young Adults With Eating Disorders: Long-Term Clinical Outcomes and Cross-Reported Experiences
This study aims to evaluate the clinical, psychological, and functional outcomes of adolescents with anorexia nervosa receiving multidisciplinary care in hospital settings. Participants are treated either in a day hospitalization program or in a full-time inpatient program, in accordance with the French national guidelines (Haute Autorité de Santé, HAS) for the management of anorexia nervosa.
The study seeks to better understand the evolution of patients' health status over time, including nutritional, psychological, and social dimensions, and to identify factors associated with treatment response. Data will be collected as part of routine clinical care without modification of the standard therapeutic management.
The results of this study may help improve clinical practices and optimize care pathways for adolescents with anorexia nervosa.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adolescents and young adults aged 12 to 22 years
- Diagnosed with an eating disorder
- Referred for admission to the day hospital program between October 2019 and December 2023
- Provided informed consent (and parental consent for minors)
Exclusion Criteria:
- Refusal to participate
- Age below 12 years or above 22 years
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Day Hospital Program
Participants admitted to a specialized multidisciplinary day hospital program for eating disorders.
|
Participants admitted to the day hospital receive a multidisciplinary treatment program including psychiatric, medical, nutritional, and psychosocial care, delivered through structured daytime sessions without overnight stay.
|
|
Другой: Non-Admitted Participants
Participants who requested admission but were not admitted to the day hospital program.
|
Participants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Change in Body Mass Index (BMI)
Временное ограничение: From admission request to at least 18 months follow-up
|
From admission request to at least 18 months follow-up
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in eating disorder psychopathology assessed by EDE-Q
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Eating disorder psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q), a self-report scale ranging from 0 to 6, with higher scores indicating more severe symptoms.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in body image concerns assessed by BSQ
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Body image concerns will be assessed using the Body Shape Questionnaire (BSQ), a self-report scale with higher scores indicating greater body dissatisfaction.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in anxiety and depression symptoms assessed by HADS
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes subscales for anxiety and depression, each ranging from 0 to 21, with higher scores indicating greater symptom severity.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in obsessive-compulsive symptoms assessed by MOCI
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Obsessive-compulsive symptoms will be assessed using the Maudsley Obsessive-Compulsive Inventory (MOCI), where higher scores indicate more severe symptoms.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in eating disorder-related quality of life assessed by EDQoL
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Quality of life related to eating disorders will be assessed using the Eating Disorders Quality of Life (EDQoL) questionnaire, with higher scores indicating greater impairment.
The assessment will be performed at admission and discharge
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in autistic traits assessed by AQ-10
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Autistic traits will be assessed using the Autism Spectrum Quotient (AQ-10), a brief screening tool with higher scores indicating more pronounced autistic traits.
The assessment will be performed at admission and discharge
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
|
Change in family functioning assessed by FAD-12
Временное ограничение: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Family functioning will be assessed using the Family Assessment Device (FAD-12), with higher scores indicating poorer family functioning.
The assessment will be performed at admission and discharge.
|
Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2024-A02535-42
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .