Trial on an Educative Structured Intervention by Peer Educators to Improve HbA1c of Patients With Type 2 Diabetes in the Sikasso Region in Mali
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Purpose
The main objective is to assess impact of the establishment of involved patients (peer educators) network in Mali. It 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 country Mali. In the country, it will be completed in one site : the region of Sikasso. This site was chosen because It 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 Post-Test Club on diabetes (PTC). PTC will be a social support club that provides on going prevention counseling, education and support services to people who have diabetes. PTC represents an important link between patients, educators and general medical services. PTC will be defined as clubs, which are facilitated by well-trained peer educators, and will have 3 objectives: to provide social and emotional support to diabetic patients, to provide assistance in daily management and living with diabetes and to provide linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative methodology for peer education: the learning nests method. 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 systolic and diastolic blood pressure and weight.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Other: Intensification of education |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Supportive Care |
| Official Title: | Randomized Controlled Trial on an Educative Structured Intervention by Peer Educators to Improve HbA1c of Patients With Type 2 Diabetes in the Sikasso Region in Mali |
- compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre
- Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | September 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Specific education intervention with peer educators |
Other: Intensification of education
The main objective is to assess impact of the establishment of involved patients (peer educators) network in Mali. Peer educators and persons targeted by the project will be recruited through Post-Test Club on diabetes (PTC). PTC will be a social support club that provides on going prevention counseling, education and support services to people who have diabetes. PTC represents an important link between patients, educators and general medical services. PTC will be defined as clubs, which are facilitated by well-trained peer educators, and will have 3 objectives: to provide social and emotional support to diabetic patients, to provide assistance in daily management and living with diabetes and to provide linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative methodology for peer education: the learning nests method. To evaluate, we propose a classical randomized controlled experimental (RCT) design, with randomization at the person-level.
|
| No Intervention: General education session in the health structure |
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
- Patients treated in units diabetes in the intervention area and performing regularly consultations
- Patients with type 2 diabetic insulin-treated or untreated
- Poorly controlled diabetes with HbA1c ≥ 8%
- Patients who agreed to undergo the whole process of peer education
- Patients who agreed to carry out all biological measures included in the Protocol
- Patients aged 30-80 years
Exclusion Criteria:
- Diabetic patients not performing their monitoring units in the area of diabetes intervention
- Patients with diabetes followed in units of the intervention area but not performing regular their consultations
- Patients with type 1 diabetes
- Scalable severe complications within 3 months preceding infection, complications heart disease, severe renal
- Associated diseases threatening or vital functional
- Refusal to participate in the study
Contacts and Locations| Mali | |
| ONG Santé Diabète Mali | |
| Bamako, Mali, BP2736 | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Besançon Stéphane (Program director ONG Santé Diabète Mali), ONG Santé Diabète Mali |
| ClinicalTrials.gov Identifier: | NCT01153048 History of Changes |
| Other Study ID Numbers: | SDMSFD01 |
| Study First Received: | June 27, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Mali : National Ethics Committee of Faculty of Medicine |
Keywords provided by Sante Diabete Mali:
|
Intensification of Education learning nest methodology peer educators |
type 2 diabetes Mali the focus of this study is on the intensification of education on the treatment of type 2 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013