- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07311356
Prognose for tidlig debuterende anoreksi nervosa (AM2P)
Evaluering af prognosen og livskvaliteten for patienter indlagt med tidlig debuterende anorexia nervosa
The AM2P study aims to evaluate the long-term prognosis and quality of life of patients with early-onset anorexia nervosa, assessed 4 to 9 years after hospitalization. Prognosis will be determined using a composite outcome measure based on questionnaire responses and health indicators, including body mass index (BMI). In addition, the study will examine the patients' overall physical condition both at the time of assessment and during the interval between their last hospitalization and the present evaluation.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study includes all patients who were hospitalized at Robert Debré Hospital in Paris between 2016 and 2021 for early-onset anorexia nervosa. During follow-up interviews, participants will complete a standardized set of questionnaires assessing their mental and physical health (EDE-Q, PHQ-9, MSI-BPD, GAD-7, and SF-12). The primary outcome is the evaluation of the severity of the eating disorder, measured with the EDE-Q. Secondary outcomes will be derived from the additional questionnaires and will include body mass index (BMI), menstrual status, follow-up data, general well-being, impact of the eating disorder, hospital readmission, suicide attempts, depressive symptoms, borderline personality traits, anxiety, quality of life, educational attainment, occupational status, and treatments received. We hypothesize that approximately 50% of patients will achieve remission three years after hospitalization.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Paris, Frankrig, 75019
- Hopital Robert Debre - AP-HP
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients suffering from early_onset anorexia nervosa
Beskrivelse
Inclusion Criteria:
- First full hospitalization in the eating disorders unit (EDU) at Robert Debré Hospital and diagnosis of AMP from 2016 to 2021
- No objection from the minor to the study
- Proficiency and understanding of the French language
- Access to digital technology (computer, smartphone, tablet, etc.)
Exclusion Criteria:
- Primary diagnosis of ARFID, other unspecified eating disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Cohorte AM2P
Completion of quality of life questionnaire, clinic |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Score of Eating Disorder Examination Questionnaire (EDE SQ) scale
Tidsramme: 6 months
|
the percentage of subjective cure |
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification of predictive factors at admission for the trajectory (remission/relapse)
Tidsramme: 6 months
|
The number of hospitalizations related to anorexia nerovsa |
6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Coline STORDEUR, MD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP250984
- 2025-A01680-49 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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