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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sante Diabete Mali.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Société Francophone du Diabète
Agence Francaise de développement (AFD)
Centre hospitalo-universiaire du Point G de Bamako (CHU Pt G)
Information provided by:
Sante Diabete Mali
ClinicalTrials.gov Identifier:
NCT01153048
First received: June 27, 2010
Last updated: July 20, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Sante Diabete Mali:

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

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153048

Locations
Mali
ONG Santé Diabète Mali
Bamako, Mali, BP2736
Sponsors and Collaborators
Sante Diabete Mali
Société Francophone du Diabète
Agence Francaise de développement (AFD)
Centre hospitalo-universiaire du Point G de Bamako (CHU Pt G)
  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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014