跳至主要内容
临床试验/NCT06218472
NCT06218472招募中不适用

Assessment of the Impact of Early Treatment for Anorexia Nervosa in a Day Hospital on Food Symptomatology, the Outcome of Young Patients, and the Family Experience

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
164
试验地点
2
主要终点
Occurrence of one or more clinical events

研究概览

简要总结

During the management of chronic illnesses, the day hospital (DH) serves as a brief and effective alternative to traditional hospitalization, offering access to multidisciplinary care. Indeed, patients can benefit from a range of therapeutic tools provided by a multidisciplinary care team while remaining in their living environment. Numerous structures exist for the management of eating disorders, but primarily for severe cases, often following hospitalization, before transitioning to outpatient care. There is no alternative for the initial management of these patients.

The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care. It allows for a thorough assessment and sustained management of eating disorders. Our hypothesis is that a multidisciplinary, intensive, and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short, medium, and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care. It would also enhance the family's experience of this pathology and their coping skills.

详细描述

The patients recruited will come from the active consultation file of the inclusion center (spontaneous consultations, referrals from healthcare professionals, etc.), whether they have had an initial consultation or not. All patients admitted to day hospital during the study period who meet the inclusion criteria will be considered. A first evaluation consultation for mental anorexia will be conducted for all patients, including a somatic and psychological assessment, as well as a consultation with a dietitian. If eligible, the patient and their family will be offered participation in day hospital (for the next session or the following one, depending on availability). In case of refusal, regardless of the reason (parents' availability, excessive distance from home, lack of motivation, etc.), patients will receive regular care in outpatient consultations. For the qualitative study, parents participating in day hospital for their adolescent will be offered inclusion in this research protocol.

The inclusion of young patients will take place over two calendar years (24 consecutive months) for the characterization of the active file. The study will continue for 5 years after the inclusion of the last patient in the study to investigate the outcome. In total, data collection for this research will last a maximum of 84 months (24 months of recruitment and a 5-year follow-up).

Visit 1 - Inclusion: collection of non-oppositions, initial clinical evaluation, then proposal to participate in the day hospital program:

  • In case of refusal or impossibility of the day hospital program: multidisciplinary follow-up "as usual" at the consultation center (outpatient group).
  • In case of acceptance of the day hospital program (day hospital group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a new evaluation at the end of the program. Outpatient follow-up thereafter.

Outpatient follow-up consists of appointments with the psychiatrist, pediatrician, and dietitian, on average, every month.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents in the age range of 12-18 years and their parents,
  • First-time consultation at the MDA for anorexia nervosa (according to DSM-5) evolving for less than 12 months,
  • Adolescents with clinical characteristics suitable for DH care.

排除标准

  • Parents and/or children who do not speak French or cannot read or write,
  • Patients who have been followed by an eating disorder specialist in the past 12 months (at the MDA or elsewhere) or previously hospitalized for anorexia nervosa,
  • Patients who have undergone family therapy in the past,
  • Patients with BMI less than 13 kg/m2 for those under 14 years old, or less than 14 kg/m2 for those over 14 years old at the initial assessment,
  • Patients with a major psychiatric comorbidity or a metabolic condition interfering with eating or its regulation,
  • Patients and families in a crisis situation requiring immediate hospitalization.

研究组 & 干预措施

Parents

干预措施: Conduct semi-structured qualitative interviews (Other)

Day hospital patient

Acceptance of the DH program (DH group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a reassessment at the end of the program. Outpatient follow-up thereafter.

干预措施: Day Hospital Treatment (Other)

Outpatient

Refusal or inability to participate in the DH program: multidisciplinary follow-up "as usual" within the service (outpatient group).

干预措施: Multidisciplinary follow-up "as usual" within the service (Other)

结局指标

主要结局

Occurrence of one or more clinical events

时间窗: 1 year after inclusion

Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 1 year. Evaluate the impact of early intervention in DH on the clinical progression of the disease compared to the usual outpatient care.

次要结局

  • Clinical characteristics collection(Inclusion)
  • Occurrence of one or more clinical events(5 years after inclusion)
  • Conduct semi-structured qualitative interviews(After DH termination = 12 weeks after inclusion)
  • Satisfaction questionnaire CSQ-8 (Consumer satisfaction questionnaire)(After DH termination = 12 weeks after inclusion)
  • Socio-demographic characteristics collection(Inclusion)
  • Semi-structured interviews (DH program group)(From 6 to 12 months after the end of day hospital (visit 2 or 3 - DH program group))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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