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

Last updated: February 28, 2022
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Vomiting

Treatment

N/A

Clinical Study ID

NCT04102475
2017_73
2018-A02536-49
  • Ages > 15
  • All Genders

Study 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

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 byboth parents who have parental authority )
  • With medical insurance
  • Can be reached by telephone

Exclusion

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

Study Design

Total Participants: 270
Study Start date:
March 18, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Centre Hospitalier Général

    Hénin-Beaumont,
    France

    Site Not Available

  • Hôpital Fontan2, CHU

    Lille,
    France

    Active - Recruiting

  • Hôpital Saint Vincent de Paul, GHICL

    Lille,
    France

    Site Not Available

  • Cliniqie Lautreamont

    Loos,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • Centre Hospitalier Universitaire

    Nantes,
    France

    Site Not Available

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