DiabetesNCT01485913
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
A study testing intensive education intervention using a network of involved diabetic patients (peer educators) in people with Diabetes, run by Sante Diabete Mali at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- intensive education intervention using a network of involved diabetic patients (peer educators)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteMali
- Study dates
- 1 Jul 2011to 30 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Title of project:
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
Research question (s)/hypothesis:
Main objective of the research: compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre
Secondary objectives:
Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size
Method (s) :
This study 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 site in one country Mali.
This site was chosen because they 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 the local association of patients. This association will be a social support that provides on going prevention counseling, education and support services to people who have diabetes. It represents an important link between patients, educators and general medical services. The procedure will start by the training of peer educators who were identified and recruited to facilitate the sessions
Then, the 4 educational sessions: control of cardiovascular risk (blood pressure, waist circumference, smoking, cholesterol, glycaemia), control of Food (balance, fat, carbohydrates), physical activity management, insulin management, will be carried out and patients will be able to:
- Analyze knowledge that appears in various forms, including forms adapted to illiterate patients (colour codes, presence of photos)
- Act on knowledge: the patient observes, makes hypothesis, he experiments, compares, deduces, analyzes, makes relations.
- Work in interaction with other learners, which gives education a social dimension.
- Decide on the implementation of actions taking into account individual, cultural, social, economic context
For each situation, a day of training will be conducted by trained peer educators with theoretical contributions on the issue, practical scenarios, analyzes of the issues out of frame and put in "educational security ". These training days will be implemented with 8-10 patients (1Hour and an half) and the 4 sessions will take place over a period of two months starting from the inclusion of patients.
2 groups of 75 persons will be formed. One group will have specific education using methodology of learning nests. The other group will be a control group not subject to this specific education.
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 in systolic, diastolic blood pressure, and weight.
Public health significance (state how the project applies to your community and it potential impact(s))
It is very important to find an education methodology adapted to the African context. This line of diabetes management is essential to improve the management of African diabetic patients.
Sustainability plan:
If the evaluation of this methodology is conclusive, the Malian state will implement the methodology in the 22 diabetes units of the country.
- Conditions
- Diabetes
- Being tested
- intensive education intervention using a network of involved diabetic patients (peer educators)
- Keywords
- Education, Diabetes, Prevention complications, Prevention of complications of diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 ...) Receives: 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 ...) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
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.
Measured: evolution at T = 0, 3 months, 6 months and 12 months of the systolic and diastolic blood pressure, weight, BMI and waist measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study start1 Jul 2011
- Primary completion31 Dec 2012
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sante Diabete Mali
- Sponsor type
- University, hospital or other
- Collaborators
- Bridges program, International Diabetes Federation
- Responsible party
- Principal investigator, Besancon Stephane, Sante Diabete Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485913
- Sponsor's protocol ID
- SDMBRIDGES01
- Status last verified
- Apr 2017
- First submitted
- 20 Jul 2011
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29357380
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01485913
- Acronym / sponsor ID
- SDMBRIDGES01
- Conditions
- Diabetes
- Keywords
- Education, Diabetes, Prevention complications, Prevention of complications of diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Sante Diabete MaliUniversity, hospital or other
- Collaborators
- Bridges program, International Diabetes Federation
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title of project:
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
Research question (s)/hypothesis:
Main objective of the research: compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre
Secondary objectives:
Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size
Method (s) :
This study 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 site in one country Mali.
This site was chosen because they 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 the local association of patients. This association will be a social support that provides on going prevention counseling, education and support services to people who have diabetes. It represents an important link between patients, educators and general medical services. The procedure will start by the training of peer educators who were identified and recruited to facilitate the sessions
Then, the 4 educational sessions: control of cardiovascular risk (blood pressure, waist circumference, smoking, cholesterol, glycaemia), control of Food (balance, fat, carbohydrates), physical activity management, insulin management, will be carried out and patients will be able to:
- Analyze knowledge that appears in various forms, including forms adapted to illiterate patients (colour codes, presence of photos)
- Act on knowledge: the patient observes, makes hypothesis, he experiments, compares, deduces, analyzes, makes relations.
- Work in interaction with other learners, which gives education a social dimension.
- Decide on the implementation of actions taking into account individual, cultural, social, economic context
For each situation, a day of training will be conducted by trained peer educators with theoretical contributions on the issue, practical scenarios, analyzes of the issues out of frame and put in "educational security ". These training days will be implemented with 8-10 patients (1Hour and an half) and the 4 sessions will take place over a period of two months starting from the inclusion of patients.
2 groups of 75 persons will be formed. One group will have specific education using methodology of learning nests. The other group will be a control group not subject to this specific education.
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 in systolic, diastolic blood pressure, and weight.
Public health significance (state how the project applies to your community and it potential impact(s))
It is very important to find an education methodology adapted to the African context. This line of diabetes management is essential to improve the management of African diabetic patients.
Sustainability plan:
If the evaluation of this methodology is conclusive, the Malian state will implement the methodology in the 22 diabetes units of the country.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Other: intensive education intervention using a network of involved diabetic patients (peer educators)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 ...) |
| 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 ...) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Lifestyle counseling |
Primary outcome
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%
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 29357380Debussche 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.
- Web site NGO Sante DiabèteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive education intervention using a network of involved diabetic patients (peer educators) in people with Diabetes, run by Sante Diabete Mali at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the intermediate evolution of the HbA1c (3, 6 and 12 months) (time frame: Change Hba1c from T0 to T12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017; AzTrials last refreshed its copy on 2 Nov 2026.