Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization (EATLINE)

University Hospital, Lille

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Other: Control; Other: Eatline

Study type: Interventional

Funder types: Other

Identifiers

NCT04102475

2018-A02536-49 (Other Identifier)

2017_73

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

eatline group

Experimental group

Treatment:

Other: Eatline

control group

Sham Comparator group

Treatment:

Other: Control