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
intensive education intervention using a network of involved diabetic patients (peer educators)
Diabetes Mellitus+2
+ Endocrine System Diseases
+ Metabolic Diseases
Supportive Care Study
Summary
Study start date: July 1, 2011
Actual date on which the first participant was enrolled.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: Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size Method (s) : This study will be conducted by a multidisciplinary team that brings together high level skills in research projects and in peer education projects. It will be conducted in one site in one country Mali. This site was chosen because they meet a functional care, access to medicines and a dynamic association of diabetic patients. Peer educators and persons targeted by the project will be recruited through the local association of patients. This association will be a social support that provides on going prevention counseling, education and support services to people who have diabetes. It represents an important link between patients, educators and general medical services. The procedure will start by the training of peer educators who were identified and recruited to facilitate the sessions Then, the 4 educational sessions: control of cardiovascular risk (blood pressure, waist circumference, smoking, cholesterol, glycaemia), control of Food (balance, fat, carbohydrates), physical activity management, insulin management, will be carried out and patients will be able to: * Analyze knowledge that appears in various forms, including forms adapted to illiterate patients (colour codes, presence of photos) * Act on knowledge: the patient observes, makes hypothesis, he experiments, compares, deduces, analyzes, makes relations. * Work in interaction with other learners, which gives education a social dimension. * Decide on the implementation of actions taking into account individual, cultural, social, economic context For each situation, a day of training will be conducted by trained peer educators with theoretical contributions on the issue, practical scenarios, analyzes of the issues out of frame and put in "educational security ". These training days will be implemented with 8-10 patients (1Hour and an half) and the 4 sessions will take place over a period of two months starting from the inclusion of patients. 2 groups of 75 persons will be formed. One group will have specific education using methodology of learning nests. The other group will be a control group not subject to this specific education. To evaluate, we propose a classical randomized controlled experimental (RCT) design, with randomization at the person-level. For outcome measures, we propose change in HbA1c, increase of social and emotional support and increase of linkage to clinical care. In addition to HbA1c, we propose measuring changes in systolic, diastolic blood pressure, and weight. Public health significance (state how the project applies to your community and it potential impact(s)) It is very important to find an education methodology adapted to the African context. This line of diabetes management is essential to improve the management of African diabetic patients. Sustainability plan: If the evaluation of this methodology is conclusive, the Malian state will implement the methodology in the 22 diabetes units of the country.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.151 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location