- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
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다른: Non-Admitted Participants
Participants who requested admission but were not admitted to the day hospital program.
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Participants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in Body Mass Index (BMI)
기간: From admission request to at least 18 months follow-up
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From admission request to at least 18 months follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in eating disorder psychopathology assessed by EDE-Q
기간: 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
기간: 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
기간: 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.
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Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
|
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Change in obsessive-compulsive symptoms assessed by MOCI
기간: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
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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.
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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
기간: 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
기간: 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
|
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Change in family functioning assessed by FAD-12
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-A02535-42
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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