Informations générales (source: ClinicalTrials.gov)
Medico-economic Evaluation of Complicated Obesity in Primary Care
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
septembre 2015
décembre 2019
29 juin 2024
The investigators developed the Aviitam® online platform. The purpose of the project is
to test the medico-economic impact related to the utilization of the Aviitam online
platform in primary care.
Primary objective: To assess the cost-effectiveness at 24 months follow-up of the
utilization of the Aviitam® online software in primary care for people with obesity and
at least one comorbidity compared to a usual follow-up in primary care.
Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in
lipid profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction,
profiling of patients and data mining analysis on the collected data.
Method : Overweight & obese patients with associated comorbidities will receive a 24
months follow-up to assess the impact of the use of the online platform Aviitam®.
Practitioners will be randomized by lot between an Aviitam® group and a control group
(usual care).
A medico-economic analysis will be conducted with a cost-effectiveness analysis and a
budget impact analysis.
With no hypothesis on the primary endpoint, the calculation of the required number of
subjects was based on the quality of life. 150 patients will be included per group
Patients of the 2 groups will be assessed at baseline and after 24 months. The first day
of each month, each patient included in the study will receive a questionnaire to fill
online to evaluate their health care consumption in the previous month and the EQ5D
questionnaire , a standardized questionnaire validated in French to assess the effects on
health and to be used to calculate cost - utility.
Expected results and perspectives Proving the effectiveness of the Aviitam® online
program focused on non-drug therapies and therapeutic lifestyle changes for overweight
and obesity management with reduced health costs, improvement in quality of life,
reduction in weight and improvement of comorbidities.
In terms of public health, the use of the platform Aviitam® can be expect to improve
management of excess body weight and reduced health costs. Furthermore, Aviitam® could be
a valuable tool to support healthcare professionals in outpatient therapeutic education
approaches.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud - 34295 - Montpellier - France | Antoine AA Avignon, PU PH | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Montpellier University Hospital - 34295 - Montpellier - France | Antoine AVIGNON, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:Man or woman aged 35-65 years Having signed an informed written
consent Being affiliated to social security
With a BMI between 25 and 45 kg / m2 and at least one of the following criteria
associated:
- A known hypertension treated or not
- A known prediabetes [fasting glucose between 110 and 126 mg / l or metabolic
syndrome as defined in the 2009 consensus of the International Diabetes Federation
and the American heart Association.
- A known type 2 diabetes, treated or not
- A known dyslipidemia treated or not
- A known sleep disorder
- A known history of cardiovascular disease> 6 months, a stable known cardiovascular
disease, peripheral arterial disease.
consent Being affiliated to social security
With a BMI between 25 and 45 kg / m2 and at least one of the following criteria
associated:
- A known hypertension treated or not
- A known prediabetes [fasting glucose between 110 and 126 mg / l or metabolic
syndrome as defined in the 2009 consensus of the International Diabetes Federation
and the American heart Association.
- A known type 2 diabetes, treated or not
- A known dyslipidemia treated or not
- A known sleep disorder
- A known history of cardiovascular disease> 6 months, a stable known cardiovascular
disease, peripheral arterial disease.
- No Having signed an informed written consent
- No Being affiliated to social security