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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02536-49 | Other Identifier | ID-RCB number, ANSM |
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lack of human and financial resources
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.
Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.
Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.
Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eatline group | Experimental |
| |
| control group | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eatline | Other | After discharge from a first hospitalization: Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance.
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| Measure | Description | Time Frame |
|---|---|---|
| change in body mass index (BMI) | from discharge of the first hospitalization to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| change in BMI from the first hospitalization | from the first hospitalization to 6 months and at 1 year | |
| Mini International Neuropsychiatric Interview (MINI) | at baseline, at 6 months , at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Cottencin, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Général | Hénin-Beaumont | France | ||||
| Hôpital Fontan2, CHU |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| Control | Other | After discharge from the first hospitalization:
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| SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders) | at baseline, at 6 months , at 1 year |
| The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory) | at baseline, at 6 months , at 1 year |
| The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire) | at baseline, at 6 months , at 1 year |
| The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale) | at baseline, at 6 months , at 1 year |
| Rate of patients lost to follow-up visits | during the one year |
| Rate of patients with at least one re-hospitalization or earlier consultations than expected | during the one year |
| Medico-economic evaluation with the MEDEC questionnaire | at 6 months, at 1 year |
| Lille |
| France |
| Hôpital Saint Vincent de Paul, GHICL | Lille | France |
| Cliniqie Lautreamont | Loos | France |
| CHU de Montpellier | Montpellier | France |
| Centre Hospitalier Universitaire | Nantes | France |