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COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa (COTIDEA)

Primary Purpose

Early Onset Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FTH then DH support
standard care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Onset Anorexia Nervosa

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hôpital Robert DebréRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

standard care

FTH (full-time hospitalisation) then day hospitalization)

Arm Description

continuation of full-time hospitalization until the minimum healthy weight is reached, 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). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.

FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

global clinical state
Clinical global impression scale (CGI).Two "sub-scores": CGI-gravity and CGI-improvement. CGI-gravity measures the severity of a subject's current clinical condition (from 1 "normal, not at all sick" to 7 "among the sickest patients"). The improvement measures the perceived improvement in clinical status between assessments (rated from 1 "Very Much Improved" to 7 "Very Much Worsened").
Weight
Evaluate a healthy weight of a FTH intervention then DH versus conventional treatment
Height
Evaluate a height of a FTH intervention then DH versus conventional treatment
Number of weight recurrences
relapse risk assessment
number of rehospitalization days
relapse risk assessment
Quality of life of patients and parents
Score on the satisfaction questionnaire (CSQ 8 and SF12)
Cost FTH then DH versus conventional treatment
Evaluate the efficiency of the FTH then DH versus FTH alone through a cost-utility analysis, and perform a cost-effectiveness analysis.
anxiety and depression
The evolution of anxiety by Children Depression Inventory scale and State-Trait Anxiety Inventory
Self-esteem
The evolution of self-esteem by Rosenberg self-esteem scale

Full Information

First Posted
July 8, 2020
Last Updated
August 2, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04479683
Brief Title
COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa
Acronym
COTIDEA
Official Title
"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"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
"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.
Detailed Description
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. Statistical analysis of the data will be carried out with the intention to treat. The BMI at 1 year between groups, as well as its bilateral 95% confidence interval (equivalent to a one-sided 97.5% confidence interval), will be estimated and compared with the predefined margin of non-inferiority (1 BMI point).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Onset Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
Other
Arm Description
continuation of full-time hospitalization until the minimum healthy weight is reached, 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). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.
Arm Title
FTH (full-time hospitalisation) then day hospitalization)
Arm Type
Experimental
Arm Description
FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level.
Intervention Type
Other
Intervention Name(s)
FTH then DH support
Intervention Description
FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level.
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
continuation of full-time hospitalization until the minimum healthy weight is reached, 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). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.
Primary Outcome Measure Information:
Title
BMI BMI
Description
body mass index (BMI) at 1 year after admission into FTH
Time Frame
one year
Secondary Outcome Measure Information:
Title
global clinical state
Description
Clinical global impression scale (CGI).Two "sub-scores": CGI-gravity and CGI-improvement. CGI-gravity measures the severity of a subject's current clinical condition (from 1 "normal, not at all sick" to 7 "among the sickest patients"). The improvement measures the perceived improvement in clinical status between assessments (rated from 1 "Very Much Improved" to 7 "Very Much Worsened").
Time Frame
3 months, 6 months and 1 year after admission into FTH
Title
Weight
Description
Evaluate a healthy weight of a FTH intervention then DH versus conventional treatment
Time Frame
at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Title
Height
Description
Evaluate a height of a FTH intervention then DH versus conventional treatment
Time Frame
at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Title
Number of weight recurrences
Description
relapse risk assessment
Time Frame
12 months
Title
number of rehospitalization days
Description
relapse risk assessment
Time Frame
12 months
Title
Quality of life of patients and parents
Description
Score on the satisfaction questionnaire (CSQ 8 and SF12)
Time Frame
6 months and 12 months
Title
Cost FTH then DH versus conventional treatment
Description
Evaluate the efficiency of the FTH then DH versus FTH alone through a cost-utility analysis, and perform a cost-effectiveness analysis.
Time Frame
12 months
Title
anxiety and depression
Description
The evolution of anxiety by Children Depression Inventory scale and State-Trait Anxiety Inventory
Time Frame
at normalization of physiological parameters,12 months
Title
Self-esteem
Description
The evolution of self-esteem by Rosenberg self-esteem scale
Time Frame
at normalization of physiological parameters,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stordeur Coline, MD
Phone
+33140032261
Email
coline.stordeur@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stordeur Coline, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stordeur Coline, PHD
Email
coline.stordeur@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa

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