Trial on an Educative Structured Intervention by Peer Educators to Improve HbA1c of Patients With Type 2 Diabetes in the Sikasso Region in Mali

NCT01153048 | Completed Phase 1 DMC

• 1 other identifier: SDMSFD01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre

Secondary Outcomes (1)

• Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size

Study Arms (2)

Specific education intervention with peer educators

EXPERIMENTAL

Other: Intensification of education

General education session in the health structure

NO INTERVENTION

Interventions

Intensification of education OTHER

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.

Specific education intervention with peer educators

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sante Diabete Mali: lead
• Société Francophone du Diabète: collaborator
• French Development Agency: collaborator
• Centre hospitalo-universiaire du Point G de Bamako (CHU Pt G): collaborator

Study Sites (1)

ONG Santé Diabète Mali

Bamako, BP2736, Mali

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

MA (1)