A Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Compare the intermediate evolution of the HbA1c (3, 6 and 12 months)
研究概览
简要总结
The project will test the implementation of a specific methodology for education of type 2 diabetic patients that will be set up using patients involved (peer educators) and 3 guides developed specifically for the therapeutic education of type 2 diabetic patients. This project will take place in 1 sites in mali : the capital Bamako. 75 diabetic patients will be subjected to intervention with this methodology and 75 other diabetic patients will be the control group. At various stages of the project, the investigators will analyze the impact on biological, anthropological constants, etc ... of the group undergoing the intervention compared to the control group.
详细描述
Title of project:
A randomized trial of an intensive education intervention using a network of involved diabetic patients (peer educators) to improve glycemic control of type 2 diabetic patients
Research question (s)/hypothesis:
Main objective of the research: compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre
Secondary objectives:
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
- Single (Care Provider)
盲法说明
The methodologist who performed the randomisation was not directly involved in the recruitment of patients. Recruiting physicians were blinded to the allocation sequence.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients followed in the diabetes units of the project area and doing regular consultations
- •Patients with type 2 diabetes or treated or not with insulin
- •Poorly controlled diabetes with HbA1c ≥ 8%
- •Patients who accepted to undergo the whole process of peer education
- •Patients who agreed to perform all biological measures included in the protocol
- •Patients aged from 30 to 80 years old
排除标准
- •Diabetic patients not carrying out their monitoring in diabetes units of the intervention area
- •Patients followed in the diabetes units of the intervention area but not realizing their consultations regularly
- •Patients with type 1 diabetes
- •Severe complications within the preceding 3 months: infection, coronary complications, severe renal failure
- •Concomitant illnesses threatening the functional or vital prognosis
结局指标
主要结局
Compare the intermediate evolution of the HbA1c (3, 6 and 12 months)
时间窗: Change Hba1c from T0 to T12
The main judgement criteria on which the analysis will be done to comply with the superiority of the contribution of a group educational approach by the peer will be the evolution of the HbA1c from the inclusion to 1 year. In practice the main measure is the measurement of glycated hemoglobin of patients expressed in %. We want to show that in the protocol by increasing the education of patients we're going to lower their HbA1c%
次要结局
- Compare the evolution of the bio-clinical parameters at 3.6, and 12 months: weight, BMI, blood pressure, waist measurement(evolution at T = 0, 3 months, 6 months and 12 months of the systolic and diastolic blood pressure, weight, BMI and waist measurement.)
研究者
Besancon Stephane
Director NGO Santé diabète
Sante Diabete Mali