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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04864626
Other study ID # 19PH227
Secondary ID 2020-A02830-39
Status Recruiting
Phase
First received
Last updated
Start date June 16, 2021
Est. completion date June 2027

Study information

Verified date June 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Marion POY, nurse
Phone 04 77 82 90 93
Email marion.poy@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The referral center for eating disorders provides for a systematic many years follow-up of patients under care with an annual assessment at the center. The investigators have recently shown the frequency of relapse in the first 7 years after diagnosis, but the literature remains poor on this epidemiology and on the risk factors for relapse. The investigators would therefore like to extend this follow-up for an additional 3 years after remission with an annual telephone nursing interview for all cured patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 2027
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with an eating disorder confirmed at the multidisciplinary consultation meeting of the referring center and considered cured (in remission). For patients with Oral Disorders, inclusion is within one year of recovery - Patient affiliated or entitled to a social security plan - Oral participation agreement - Pregnant women Exclusion Criteria: - Persons deprived of liberty - Patients under guardianship or curatorship - refusal to participate

Study Design


Intervention

Other:
semi-standardized interview
annual collection of the number of consultations and hospitalizations at the center, as well as the number of treatments
care experience questionary
questionary with 12 questions to rate the quality of the telephone reception and your feelings during the interview

Locations

Country Name City State
France CHU de SAINT-ETIENNE Saint-etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of relapses/recurrences per year 3 years
Secondary risk factors for relapse/recurrence To determinate if one or more factors below could be a risk factors for relapse/recurrence :
Age
Sex
Body mass index
Contraception use
History of an eating disorder
Intense physical activity
History of psychiatric hospitalization
History of suicide attempt
Presence of psychotropic treatment of any kind
3 years
Secondary Number of patients called per year 3 years
Secondary Number of calls made per patient per year 3 years
Secondary Number of completed calls per patient per year 3 years
Secondary Number of telephone sessions per year per patient 3 years
Secondary Duration of telephone sessions 3 years
Secondary Number of lost to follow-up per year 3 years
Secondary Number of patients not cured 3 years
Secondary Analysis of the experience of care questionnaire 3 years
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