Medico-economic Evaluation of Complicated Obesity in Primary Care
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Weight loss
研究概览
简要总结
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.
详细描述
Method : Overweight & obese patients with associated comorbidities (hypertension, prediabetes, type 2 diabetes, dyslipidemia, sleep disorders, past history of CVDs > 6 months, stable CVD, peripheral arterial disease) 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, for a total of 300 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No Having signed an informed written consent
- •No Being affiliated to social security
研究组 & 干预措施
AVIITAM Group
Utilization of the web platform Aviitam
干预措施: AVIITAM (Behavioral)
Control group
No utilization of web-platform Aviitam
结局指标
主要结局
Weight loss
时间窗: 24 months follow-up
Weight loss expressed in kg
"Quality of life" (scale)
时间窗: 24 months follow-up
Variation of scale in quality of life "Quality of life assessed by Health-Related Quality of Life (HRQOL) between M0 and M24
次要结局
- Systolic blood pressure (mmHg)(24 months)
- Diastolic blood pressure (mmHg)(24 months)
- Blood LDL Cholesterol (mmol/l)(24 months)
- HbAlc blood(24 months)
- Blood HDL Cholesterol (mmol/l)(24 months)
- Blood Triglycerides (mmol/l)(24 months)
- Blood glucose (mmol/l)(24 months)