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

NCT01485913 | Completed DMC

• 1 other identifier: SDMBRIDGES01
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Education; Diabetes; Prevention complications; Prevention of complications of diabetes

Outcome Measures

Primary Outcomes (1)

• Compare the intermediate evolution of the HbA1c (3, 6 and 12 months)

  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%

  Change Hba1c from T0 to T12

Secondary Outcomes (1)

• 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.

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

The group subjected to educations will follow the whole process of peer education described in Part 1 of this Protocol. The control group will perform these "classic" individual consultations but will not follow the whole process of peer education. The classical management in diabetes consultations consists of: * A counselling session * A measure of blood glucose * A measurement of blood pressure * A measure of weight and size * A complete clinical examination * A prescription or a renewal of treatment (diabetes pills, insulin, IEC, statins etc ...)

Other: intensive education intervention using a network of involved diabetic patients (peer educators)

No Lifestyle counseling

NO INTERVENTION

The group subjected to educations will follow the whole process of peer education described in Part 1 of this Protocol. The control group will perform these "classic" individual consultations but will not follow the whole process of peer education. The classical management in diabetes consultations consists of: * A counselling session * A measure of blood glucose * A measurement of blood pressure * A measure of weight and size * A complete clinical examination * A prescription or a renewal of treatment (diabetes pills, insulin, IEC, statins etc ...)

Interventions

intensive education intervention using a network of involved diabetic patients (peer educators) OTHER

the purpose of this methodology is to set up coordinated training and education activities targeting populations with diabetes based on a pragmatic approach (the learning nests methodology) of appropriation and construction of knowledge that takes into account the individual, social, economic, cultural context. This work is being implemented on the basis of group modules specifically designed in their running: are studied the concrete elements of knowledge to mobilize, patients' actions, the role of health the educator, indicators of progress and monitoring during sessions and on the long term. Each patient is gotten to consider the elements involved in his/her disease, and the actions that can be achieved taking into account the feasibility in his/her own context. The education monitoring is envisaged through a data compendium present in the individual booklets that are given to patients at the end of each education session.

Lifestyle counseling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sante Diabete Mali: lead
• Bridges program, International Diabetes Federation: collaborator

Study Sites (1)

Hopital National du Mali

Bamako, Mali

Location

Related Publications (1)

• Debussche X, Besancon S, Balcou-Debussche M, Ferdynus C, Delisle H, Huiart L, Sidibe AT. Structured peer-led diabetes self-management and support in a low-income country: The ST2EP randomised controlled trial in Mali. PLoS One. 2018 Jan 22;13(1):e0191262. doi: 10.1371/journal.pone.0191262. eCollection 2018.

  PMID: 29357380 DERIVED

Related Links

• Web site NGO Sante Diabète

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The methodologist who performed the randomisation was not directly involved in the recruitment of patients. Recruiting physicians were blinded to the allocation sequence.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director NGO Santé diabète

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: December 6, 2011
• Study Start: July 1, 2011
• Primary Completion: December 31, 2012
• Study Completion: June 30, 2013
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

MA (1)