Clinical trial NCT04102475: Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
Official title: Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2019-09-25
Enrollment: 270
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject over 15 years of age
* Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
* Included after a first inpatient hospitalization in specialized care
* Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
* With medical insurance
* Can be reached by telephone

Exclusion Criteria:

* Uncompensated psychiatric pathology
* Refusal to participate in the study
* The inability to consent to care (patient or his/her legal representative)
* Pregnancy
* Major incapable subject or under guardianship or judicial protection
* Homelessness
* No mastery of reading and writing

Primary outcomes:
measure: change in body mass index (BMI)
timeFrame: from discharge of the first hospitalization to 12 months.
Secondary outcomes:
measure: change in BMI from the first hospitalization
timeFrame: from the first hospitalization to 6 months and at 1 year
measure: Mini International Neuropsychiatric Interview (MINI)
timeFrame: at baseline, at 6 months , at 1 year
measure: SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
timeFrame: at baseline, at 6 months , at 1 year
measure: The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
timeFrame: at baseline, at 6 months , at 1 year
measure: The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
timeFrame: at baseline, at 6 months , at 1 year
measure: The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
timeFrame: at baseline, at 6 months , at 1 year
measure: Rate of patients lost to follow-up visits
timeFrame: during the one year
measure: Rate of patients with at least one re-hospitalization or earlier consultations than expected
timeFrame: during the one year
measure: Medico-economic evaluation with the MEDEC questionnaire
timeFrame: at 6 months, at 1 year
Other outcomes:
Locations:
city: Hénin-Beaumont
country: France
facility: Centre Hospitalier Général
city: Lille
country: France
facility: Hôpital Fontan2, CHU
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul, GHICL
city: Loos
country: France
facility: Cliniqie Lautreamont
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: University Hospital, Lille
name: Olivier Cottencin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: