Terminé

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

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Ce qui est testé

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

Autre
Qui peut participer

Diabète Mellitus+2

+ Maladies du système endocrinien

+ Maladies métaboliques

De 30 à 80 ans
+11 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Soins de support

Interventionnel
Date de début : juillet 2011
Voir le détail du protocole

Résumé

Sponsor principalSante Diabete Mali
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juillet 2011

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielA 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
Sponsor principalSante Diabete Mali
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

151 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Soins de support

Cette étude teste des approches visant à améliorer le confort, le bien-être ou la qualité de vie des personnes atteintes d'une maladie, notamment en aidant à mieux gérer les symptômes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 30 à 80 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Diabète MellitusMaladies du système endocrinienMaladies métaboliquesMaladies nutritionnelles et métaboliquesTroubles du métabolisme du glucose

Critères

6 critères d'inclusion nécessaires pour participer
Patients aged from 30 to 80 years old

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%

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5 critères d'exclusion empêchent la participation
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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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 ...)

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Hopital National du Mali

Bamako, MaliOuvrir Hopital National du Mali dans Google Maps
Terminé1 Centres d'Étude