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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485913
First Posted: December 6, 2011
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bridges program, International Diabetes Federation
Information provided by (Responsible Party):
Besancon Stephane, Sante Diabete Mali
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:
The methodologist who performed the randomisation was not directly involved in the recruitment of patients. Recruiting physicians were blinded to the allocation sequence.
Primary Purpose: Supportive Care
Official Title: 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

Further study details as provided by Besancon Stephane, Sante Diabete Mali:

Primary Outcome Measures:
  • Compare the intermediate evolution of the HbA1c (3, 6 and 12 months) [ Time Frame: Change Hba1c from T0 to T12 ]

    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%



Secondary Outcome Measures:
  • Compare the evolution of the bio-clinical parameters at 3.6, and 12 months: weight, BMI, blood pressure, waist measurement [ Time Frame: evolution at T = 0, 3 months, 6 months and 12 months of the systolic and diastolic blood pressure, weight, BMI and waist measurement. ]

    The secondary judgement criteria will be the evolution at T = 0, 3 months, 6 months and 12 months of the systolic and diastolic blood pressure, weight, BMI and waist measurement.

    In practice the secondaries measure is the measurement of blood pressure, size (m), weight (Kg) and weist mesurement (cm). We want to show that in the protocol by increasing the education of patients we're going to lower their blood pressure, BMI, weight and weist mesurement.



Enrollment: 151
Actual Study Start Date: July 1, 2011
Study Completion Date: June 30, 2013
Primary Completion Date: December 31, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling

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)
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.
No Intervention: No Lifestyle counseling

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 ...)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485913


Locations
Mali
Hopital National du Mali
Bamako, Mali
Sponsors and Collaborators
Sante Diabete Mali
Bridges program, International Diabetes Federation
  More Information

Additional Information:
Responsible Party: Besancon Stephane, Director NGO Santé diabète, Sante Diabete Mali
ClinicalTrials.gov Identifier: NCT01485913     History of Changes
Other Study ID Numbers: SDMBRIDGES01
First Submitted: July 20, 2011
First Posted: December 6, 2011
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Besancon Stephane, Sante Diabete Mali:
Education
Diabetes
Prevention complications
Prevention of complications of diabetes