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

Anorexia Nervosa Clinical Trial

— EVA-FAM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218472
• Other study ID #: APHP231594
• Secondary ID: 2023-A02047-38
• Status: Recruiting
• Start date: February 19, 2024
• Est. completion date: February 2031

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Corinne BLANCHET, MD, PhD
• Phone: 00 33 1 58 41 24 24
• Email: corinne.blanchet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 family's experience of this pathology and their coping skills.

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 adolescent's follow-up, may be added to care if necessary. It can be conducted by phone, depending on the adolescent's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: February 2031
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Adolescents in the age range of 12-18 years and their parents,

• First-time consultation at the MDA for anorexia nervosa (according to DSM-5) evolving for less than 12 months,

• Adolescents with clinical characteristics suitable for DH care.

Exclusion Criteria:

• Parents and/or children who do not speak French or cannot read or write,

• Patients who have been followed by an eating disorder specialist in the past 12 months (at the MDA or elsewhere) or previously hospitalized for anorexia nervosa,

• Patients who have undergone family therapy in the past,

• Patients with BMI less than 13 kg/m2 for those under 14 years old, or less than 14 kg/m2 for those over 14 years old at the initial assessment,

• Patients with a major psychiatric comorbidity or a metabolic condition interfering with eating or its regulation,

• Patients and families in a crisis situation requiring immediate hospitalization.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Day Hospital Treatment
Scheduling of 12 half-day sessions per week, alternating between sessions with only the patients or involving the entire family. Close medical monitoring and multidisciplinary interventions during sessions (pediatrician, psychiatrist, dietitian, recovered former patients...).
• Multidisciplinary follow-up "as usual" within the service
Multidisciplinary follow-up "as usual" within the service
• Conduct semi-structured qualitative interviews
Conduct semi-structured qualitative interviews

Locations

Country	Name	City	State
France	Maison de Solenn Maison des Adolescents, Cochin Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of one or more clinical events	Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 1 year.; Evaluate the impact of early intervention in DH on the clinical progression of the disease compared to the usual outpatient care.	1 year after inclusion
Secondary	Occurrence of one or more clinical events	Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 5 years in both care groups.; Evaluate the long-term impact of early intervention in DH on the clinical progression of the disease, compared to the usual outpatient care.	5 years after inclusion
Secondary	Conduct semi-structured qualitative interviews	Conduct semi-structured qualitative interviews with parents after participation in the DH program.; Explore the experience and perspectives of families participating in a new day hospital care program for adolescents with recent anorexia nervosa.	After DH termination = 12 weeks after inclusion
Secondary	Satisfaction questionnaire CSQ-8 (Consumer satisfaction questionnaire)	Satisfaction questionnaire at the end of DH care. Assess the satisfaction level of the patient and their parents regarding DH care.; The range of possible scores is 8-32; (32 = higher satisfaction = better outcome, 8 = lower satisfaction)	After DH termination = 12 weeks after inclusion
Secondary	Clinical characteristics collection	Initial clinical characteristics at the time of inclusion. Determine predictive factors for the outcome at the end of the intervention and in the long term.	Inclusion
Secondary	Socio-demographic characteristics collection	Initial socio-demographic characteristics at the time of inclusion. Determine predictive factors for the outcome at the end of the intervention and in the long term.	Inclusion