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临床试验/NCT04479683
NCT04479683招募中不适用

"COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study"

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
88
试验地点
2
主要终点
BMI BMI

研究概览

简要总结

"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.

In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.

详细描述

The objective of the study is to demonstrate the non-inferiority of DH management after a short full-time hospitalisation compared to a prolonged full-time hospitalisation aiming at a healthy weight on the evolution of BMI at 1 year in children aged 8 to 13 years suffering from anorexia nervosa, with severe undernutrition.

The minimum healthy weight is defined by a weight corresponding to the BMI corridor prior to the diagnosis of anorexia nervosa, +/- 1 corridor).

Randomized controlled trial, open-label, single-centre.

Patients will be randomized into one of the two arms of the trial:

  • Group 1 (control group): continuation of full-time hospitalisation until reaching the minimum healthy weight, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile).
  • Group 2 (experimental group): Exit from FTH (full-time hospitalisation ) and relay to DH (day hospitalization ) one day per week until the minimum healthy weight. This treatment combines a one-day medical evaluation by a senior psychiatrist, family sessions (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Anorexia Nervosa according to diagnostic mental disorders(DSM 5) criteria;
  • Age at diagnosis 8 to 13 years inclusive;
  • Indication for full-time hospitalisation according to supreme health authority (HAS 2010) criteria, see appendix;
  • First hospitalization in the Eating Disorders (ED) unit of the Child and Adolescent Psychiatry Department at Robert Debré Hospital.
  • Informed consent of the holder(s) of parental authority
  • Patient affiliated to a social security

排除标准

  • Other early onset eating disorders (ARFID to DSM 5 criteria) ;
  • Underlying unbalanced somatic disease (especially gastroenterological);
  • Psychiatric indication for continued hospitalisation (in particular significant suicidal risk according to the psychiatric criteria for full-time hospitalisation for anorexia nervosa of the HAS, 2010, cf. appendix)
  • Environmental indication for continued full-time hospitalization according to the HAS environmental criteria for full-time hospitalization for anorexia nervosa, 2010, cf. appendix) ;
  • History of full-time hospitalisation in our ED unit.

结局指标

主要结局

BMI BMI

时间窗: one year

body mass index (BMI) at 1 year after admission into FTH

次要结局

  • global clinical state(3 months, 6 months and 1 year after admission into FTH)
  • number of rehospitalization days(12 months)
  • Quality of life of patients and parents(6 months and 12 months)
  • Cost FTH then DH versus conventional treatment(12 months)
  • Number of weight recurrences(12 months)
  • Height(at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH)
  • Self-esteem(at normalization of physiological parameters,12 months)
  • Weight(at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH)
  • anxiety and depression(at normalization of physiological parameters,12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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