Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538220
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Evaluation of the Care Pathway Offered by the Chronic Disease Unit to Obese Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Care Pathway Offered by the Chonic Disease Unit to Obese Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVAMMACH
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
Thats 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 ie 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
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
Thats 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 ie 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 protocols 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None