Evaluation of the Care Pathway Offered by the "Chronic Disease Unit" to Obese Patients

Официальное название

Evaluation of the Care Pathway Offered by the "Chonic Disease Unit" to Obese Patients

Обзор

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, 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.

Подробное описание

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 Efficacy 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.

Вмешательства

• Поведенческое Questionnaires and focus group
  To evaluate the Chronic Disease Unit care pathway, patients will respond to questionnaires : quality of life (SF-12), personal efficacy scale (GSES), "Specific self Efficacy related to Weight Management" (SEWM), Rosenberg self-esteem, body image satisfaction (QIC), state of anxiety and depression (HAD), Chronic Disease Unit satisfaction. Some patients will also participate to focus group.

Первичные конечные точки

• To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M6 [Срок оценки: 0 month and 6 months (M6)]

Вторичные конечные точки (11)

• To evaluate whether the care pathway proposed by the Chronic Disease Unit improves the self-efficacy of obese patients at M3 [Срок оценки: 0 month and 6 months (M6)]
• To assess whether the care pathway improves overall quality of life at M3 and M6 [Срок оценки: 0 month, 3 and 6 months]
• Evaluate the effect of the treatment pathway on the patient's corpulence between M0 and M6. [Срок оценки: 0 month and 6 months]
• To assess disruptions in care [Срок оценки: 6 months]
• To study the socio-demographic and clinical characteristics of patients at M0 [Срок оценки: 0 month]
• Evaluate the effect of the Chronic Disease Unit care pathway between M0 and M6, in the subgroup of patients with Eating Disorders. [Срок оценки: 0 month and 6 months]
• Evaluate patient adherence to the Chronic Disease Unit care pathway at M3 and M6 [Срок оценки: 3 and 6 months]
• Assess patients' self-esteem at M0, M3 and M6 [Срок оценки: 0 month, 3 and 6 months]
• Evaluate patient satisfaction with body image at M0, M3 and M6 [Срок оценки: 0 month, 3 and 6 months]
• Assess patients' anxiety and depression at M0 and M6 [Срок оценки: 0 month and 6 months]
• Evaluate patient satisfaction with the Chronic Disease Unit care pathway at M6 [Срок оценки: 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• MMC — La Garde

Идентификаторы

NCT: NCT06538220 · 2022-CHITS-004 · 2024-A00145-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗