Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218472
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-08
Brief Title:
Assessment of the Impact of Early Treatment for Anorexia Nervosa in a Day Hospital on Food Symptomatology the Outcome of Young Patients and the Family Experience
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of the Impact of Early Treatment for Anorexia Nervosa in a Day Hospital on Food Symptomatology the Outcome of Young Patients and the Family Experience
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVA-FAM
Brief Summary:
During the management of chronic illnesses the day hospital DH serves as a brief and effective alternative to traditional hospitalization offering access to multidisciplinary care Indeed patients can benefit from a range of therapeutic tools provided by a multidisciplinary care team while remaining in their living environment Numerous structures exist for the management of eating disorders but primarily for severe cases often following hospitalization before transitioning to outpatient care There is no alternative for the initial management of these patients
The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care It allows for a thorough assessment and sustained management of eating disorders Our hypothesis is that a multidisciplinary intensive and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short medium and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care It would also enhance the familys experience of this pathology and their coping skills
The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care It allows for a thorough assessment and sustained management of eating disorders Our hypothesis is that a multidisciplinary intensive and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short medium and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care It would also enhance the familys experience of this pathology and their coping skills
Detailed Description:
The patients recruited will come from the active consultation file of the inclusion center spontaneous consultations referrals from healthcare professionals etc whether they have had an initial consultation or not All patients admitted to day hospital during the study period who meet the inclusion criteria will be considered A first evaluation consultation for mental anorexia will be conducted for all patients including a somatic and psychological assessment as well as a consultation with a dietitian If eligible the patient and their family will be offered participation in day hospital for the next session or the following one depending on availability In case of refusal regardless of the reason parents availability excessive distance from home lack of motivation etc patients will receive regular care in outpatient consultations For the qualitative study parents participating in day hospital for their adolescent will be offered inclusion in this research protocol
The inclusion of young patients will take place over two calendar years 24 consecutive months for the characterization of the active file The study will continue for 5 years after the inclusion of the last patient in the study to investigate the outcome In total data collection for this research will last a maximum of 84 months 24 months of recruitment and a 5-year follow-up
Visit 1 - Inclusion collection of non-oppositions initial clinical evaluation then proposal to participate in the day hospital program
In case of refusal or impossibility of the day hospital program multidisciplinary follow-up as usual at the consultation center outpatient group
In case of acceptance of the day hospital program day hospital group scheduling of 10 to 12 sessions over 12 weeks during a program session followed by a new evaluation at the end of the program Outpatient follow-up thereafter
Outpatient follow-up consists of appointments with the psychiatrist pediatrician and dietitian on average every month
Follow-up visits
Day hospital group only - at approximately 12 weeks Visit 1bis clinical evaluation at the end of the program semi-structured interviews with parents
Visit 2 - at 6 months evaluations with a search for clinical events
Visit 3 - at 12 months evaluations with a search for clinical events
End of research visit
- Visit 4 - at 5 years evaluations with a search for clinical events
Visits V2 V3 and V4 can be conducted by phone Visit V4 not necessarily planned as part of the adolescents follow-up may be added to care if necessary It can be conducted by phone depending on the adolescents choice
For participants who have taken part in the day hospital program or outpatient follow-up before the implementation of this protocol and who meet the inclusion criteria the information sheet will be provided to them during a consultation by an investigator and non-opposition will be obtained at the next consultation In case of agreement to participate data from already conducted visits will be collected retrospectively and patients will then be contacted for the yet-to-be-performed assessment visits at 6 months if applicable 1 year if applicable and 5 years
The inclusion of young patients will take place over two calendar years 24 consecutive months for the characterization of the active file The study will continue for 5 years after the inclusion of the last patient in the study to investigate the outcome In total data collection for this research will last a maximum of 84 months 24 months of recruitment and a 5-year follow-up
Visit 1 - Inclusion collection of non-oppositions initial clinical evaluation then proposal to participate in the day hospital program
In case of refusal or impossibility of the day hospital program multidisciplinary follow-up as usual at the consultation center outpatient group
In case of acceptance of the day hospital program day hospital group scheduling of 10 to 12 sessions over 12 weeks during a program session followed by a new evaluation at the end of the program Outpatient follow-up thereafter
Outpatient follow-up consists of appointments with the psychiatrist pediatrician and dietitian on average every month
Follow-up visits
Day hospital group only - at approximately 12 weeks Visit 1bis clinical evaluation at the end of the program semi-structured interviews with parents
Visit 2 - at 6 months evaluations with a search for clinical events
Visit 3 - at 12 months evaluations with a search for clinical events
End of research visit
- Visit 4 - at 5 years evaluations with a search for clinical events
Visits V2 V3 and V4 can be conducted by phone Visit V4 not necessarily planned as part of the adolescents follow-up may be added to care if necessary It can be conducted by phone depending on the adolescents choice
For participants who have taken part in the day hospital program or outpatient follow-up before the implementation of this protocol and who meet the inclusion criteria the information sheet will be provided to them during a consultation by an investigator and non-opposition will be obtained at the next consultation In case of agreement to participate data from already conducted visits will be collected retrospectively and patients will then be contacted for the yet-to-be-performed assessment visits at 6 months if applicable 1 year if applicable and 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02047-38 | OTHER | France Ministry of Health | None |