Clinical trial NCT06538220: Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients
Official title: Evaluation of the Care Pathway Offered by the "Chonic Disease Unit" to Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Care pathway
Self-efficacy
Patient education
Obesity
Interdisciplinary
Self mangement
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Maison de la Maladie Chronique
name: Institut d'Etude de la Maladie Chronique
First posted: 2024-08-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity is a chronic and progressive disease medically defined as an increase in body fat, with consequences for physical, psychological and social well-being. With an estimated prevalence of 17% in France, obesity and its management remain a major public health issue. Projections by the World Health Organisation (WHO) show that the prevalence of non-communicable diseases, including obesity, is set to rise again by 2030 in all European countries.

To support patients and prevent obesity development, the French National Authority for Health (HAS) advocates change in practices and places patient education at the heart of care. The management of chronic diseases such as obesity must be offered on a long-term basis, adapting to complications onset, and patients must become active players in their treatment and the proposed care pathway. However, our experience shows that patients have difficulty finding their way around a care pathway and identifying the medical or paramedical resources that could help them to set their health goals and initiate change.

That's why the Var region has developed the "Chronic Disease Unit", which offers coordinated, adapted and individualised care pathways for patients suffering from chronic illnesses, including obesity; therapeutic education and the psychosocial dimension are at the heart of the Chronic Disease Unit approach. Depending on their psychosocial skills, each patient will be encouraged to develop skills at their own pace, but also to become autonomous in managing their illness and taking part in the healthcare decisions about them. To be autonomous, a patient must not only know what to do, but also feel able to do it, i.e. develop a sense of self-efficacy. When they have the necessary skills and believe in their abilities, patients are more likely to adopt health-promoting behaviours. While obesity generally seems to be linked to a low self-efficacy, the self-efficacy appears to be involved in weight management quality, programme commitment to a programme and the weight loss extent that results.

The aim of EVAMMACH study is to evaluate if the Chronic Disease Unit care pathway could promote obese patients' sense of self-efficacy and meet their expectations?

Detailed description: Patients will be identified at the Chronic Disease Unit during an orientation consultation with the dietician as part of routine practice. The clinician, who is also the study investigator, will then select patients who meet the protocol's inclusion criteria and inform them of the research. He will explain the study in detail and give them the information letter.

Patients will then be seen again in consultation during 3 visits:

* M0: During this consultation, the investigating physician will obtain oral consent of patients to their participation in the research, resulting in a research consultation lasting around 45 minutes and including questionnaires completion: quality of life (SF-12), personal efficacy scale (GSES), "Specific self Effecicacy related to Weight Management" (SEWM), Rosenberg self-esteem, body image satisfaction (QIC), state of anxiety and depression (HAD).
* M3: Follow-up visit with completion of SF-12, GSES, Rosenberg and QIC questionnaires.
* M6: Follow-up visit with completion of the same questionnaires as at M0 plus the Chronic Disease Unit satisfaction questionnaire, and end of research.

Questionnaires will be completed in presence of the Chronic Disease Unit psychologist, to offer a discussion or treatment if necessary.

During M0 and M6 visits, some patients will participate in a focus group. An audio recording of the focus group sessions will be made after obtaining the participants' consent.

Eligibility criteria: Inclusion Criteria:

1. Patient identified by the network or referred by a healthcare professional,
2. Patient aged 18 or over,
3. Patient suffering from obesity defined by a BMI ≥ 30,
4. Patient who understands and speaks French.

Exclusion Criteria:

1. Opposition of the patient to participation in the study,
2. Pregnant, parturient or breast-feeding woman,
3. Patient undergoing bariatric surgery,
4. Patient under judicial protection (guardianship, curatorship, etc.) or safeguard of justice,
5. Patients with unstable psychiatric disorders,
6. Patients on neuroleptics,
7. Any other reason which in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Primary outcomes:
measure: To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M6
timeFrame: 0 month and 6 months (M6)
Secondary outcomes:
measure: To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M3
timeFrame: 0 month and 6 months (M6)
measure: To assess whether the care pathway improves overall quality of life at M3 and M6
timeFrame: 0 month, 3 and 6 months
measure: Evaluate the effect of the treatment pathway on the patient's corpulence between M0 and M6.
timeFrame: 0 month and 6 months
measure: To assess disruptions in care
timeFrame: 6 months
measure: To study the socio-demographic and clinical characteristics of patients at M0
timeFrame: 0 month
measure: Evaluate the effect of the Chronic Disease Unit care pathway between M0 and M6, in the subgroup of patients with Eating Disorders.
timeFrame: 0 month and 6 months
measure: Evaluate patient adherence to the Chronic Disease Unit care pathway at M3 and M6
timeFrame: 3 and 6 months
measure: Assess patients' self-esteem at M0, M3 and M6
timeFrame: 0 month, 3 and 6 months
measure: Evaluate patient satisfaction with body image at M0, M3 and M6
timeFrame: 0 month, 3 and 6 months
measure: Assess patients' anxiety and depression at M0 and M6
timeFrame: 0 month and 6 months
measure: Evaluate patient satisfaction with the Chronic Disease Unit care pathway at M6
timeFrame: 6 months
Other outcomes:
measure: To assess whether the care pathway proposed by Chronic Disease Unit improves obese patients' sense of self-efficacy between M0 and M6.
timeFrame: 0 month and 6 months
measure: Using the focus group method, to qualitatively assess the obese patient's experience before (M0) and after (M6) treatment in the Chronic Disease Unit care pathway.
timeFrame: 0 month and 6 months
Locations:
city: La Garde
country: France
facility: MMC
state: Var
Study officials:
affiliation: MMC / IEMC
name: Aurelie GAZAGNE, Dietician
role: STUDY_DIRECTOR
References: