- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864626
Study of the Impact on the Evolution of the Disease in the Medium Term of the Implementation of a System of Extended Follow-up by Telephone Interview of Patients With an Eating Disorder Organized by the Nurses of the Eating Disorder Referral Center (SPETCA)
October 13, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marion POY, nurse
- Phone Number: +33 04 77 82 90 93
- Email: marion.poy@chu-st-etienne.fr
Study Contact Backup
- Name: Hélène RAINGARD, CRA
- Phone Number: +33 04.77.82.97.03
- Email: helene.raingard@chu-st-etienne.fr
Study Locations
-
-
-
Saint-etienne, France, 42000
- Recruiting
- CHU de Saint-Etienne
-
Sub-Investigator:
- Bogdan GALUSCA, Md
-
Sub-Investigator:
- Marianne FAVENNEC, MD
-
Sub-Investigator:
- Barbara DREVET, MD
-
Sub-Investigator:
- Catherine MASSOUBRE, MD
-
Sub-Investigator:
- Odile RICHARD COLMANT, MD
-
Sub-Investigator:
- Gwenaëlle BELLETON, MD PhD
-
Sub-Investigator:
- Natacha GERMAIN, MD PhD
-
Sub-Investigator:
- Priscille MONTAGNE PELISSIER, MD
-
Sub-Investigator:
- Pauline ACHARD, MD
-
Sub-Investigator:
- Baptiste RAVEY, MD
-
Sub-Investigator:
- Isabelle Villard, nurse
-
Sub-Investigator:
- Lucile GONNAUD, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patient with eating disorders
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient with eating disorder
|
annual collection of the number of consultations and hospitalizations at the center, as well as the number of treatments
questionary with 12 questions to rate the quality of the telephone reception and your feelings during the interview
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of relapses/recurrences per year
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
risk factors for relapse/recurrence
Time Frame: 3 years
|
To determinate if one or more factors below could be a risk factors for relapse/recurrence :
|
3 years
|
Number of patients called per year
Time Frame: 3 years
|
3 years
|
|
Number of calls made per patient per year
Time Frame: 3 years
|
3 years
|
|
Number of completed calls per patient per year
Time Frame: 3 years
|
3 years
|
|
Number of telephone sessions per year per patient
Time Frame: 3 years
|
3 years
|
|
Duration of telephone sessions
Time Frame: 3 years
|
3 years
|
|
Number of lost to follow-up per year
Time Frame: 3 years
|
3 years
|
|
Number of patients not cured
Time Frame: 3 years
|
3 years
|
|
Analysis of the experience of care questionnaire
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marion POY, nurse, CHU Saint Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2021
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 26, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19PH227
- 2020-A02830-39 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrence
-
Portuguese Oncology Institute, CoimbraCompletedColorectal Cancer | Recurrence, Local NeoplasmPortugal
-
Chinese PLA General HospitalRecruitingHCC | Recurrence TumorChina
-
Paracelsus Medical UniversityHeinrich-Heine University, Duesseldorf; Poznan University of Medical Sciences; University Hospital of Ferrara and other collaboratorsCompletedToxicity | Local Neoplasm RecurrenceAustria
-
General Hospital GroeningeUniversitaire Ziekenhuizen KU Leuven; Jessa Hospital; University Hospital, Ghent and other collaboratorsNot yet recruiting
-
Dallas VA Medical CenterTerminatedSolid Tumors | Cancer RecurrenceUnited States
-
The University of Hong KongHealth and Medical Research FundNot yet recruitingCancer | Fear of Cancer Recurrence
-
German Centre for Assessment and Evaluation of...Not yet recruitingComplication | Continence | Potency | Biochemical RecurrenceGermany
-
The University of Hong KongNot yet recruitingCancer | Fear of Cancer Recurrence
-
RottapharmTerminatedHCV Recurrence After Liver Transplantation
-
The University of Hong KongHealth and Medical Research FundNot yet recruitingCancer | Fear of Cancer Recurrence | Psychooncology
Clinical Trials on semi-standardized interview
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Multiple Sclerosis | Parkinson Disease | Rehabilitation | Neurologic Disorder | NeurosurgeryItaly
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Hospices Civils de LyonCompleted
-
University of OxfordCompletedCeliac Disease | Mental Health Wellness 1 | Emotional Problem | Stigma, Social | Celiac Disease in Children | Celiac | DisclosureUnited Kingdom
-
University Hospital, BordeauxCompleted
-
University Hospital, GrenobleNot yet recruitingSchizophrenia | Schizophrenia Schizoaffective
-
The Hong Kong Polytechnic UniversityRecruitingIntensive Care Units, PediatricHong Kong
-
Fondation Hôpital Saint-JosephRecruiting
-
Universitair Ziekenhuis BrusselVrije Universiteit BrusselNot yet recruiting