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Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island

BACKGROUND: Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and...

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Autores principales: Debussche, Xavier, Collin, Fidéline, Fianu, Adrian, Balcou-Debussche, Maryvette, Fouet-Rosiers, Isabelle, Koleck, Michèle, Favier, François
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3537557/
https://www.ncbi.nlm.nih.gov/pubmed/22856504
http://dx.doi.org/10.1186/1475-2840-11-91
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author Debussche, Xavier
Collin, Fidéline
Fianu, Adrian
Balcou-Debussche, Maryvette
Fouet-Rosiers, Isabelle
Koleck, Michèle
Favier, François
author_facet Debussche, Xavier
Collin, Fidéline
Fianu, Adrian
Balcou-Debussche, Maryvette
Fouet-Rosiers, Isabelle
Koleck, Michèle
Favier, François
author_sort Debussche, Xavier
collection PubMed
description BACKGROUND: Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications. METHODS/DESIGN: ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomised in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age ≥18 years, type 2 diabetes treated for more than one year, HbA1c ≥ 7.5% for ≥3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of physical activity, food ingestion, quality of life, social support, anxiety, depression levels and self-efficacy. An associated nested qualitative study will be conducted with 30 to 40 subjects in order to analyse the learning and adaptation processes during the education cycles, and throughout the study. CONCLUSIONS: This research will help to address the necessary but difficult issue of structuring therapeutic education in type 2 diabetes based on: efficacy and potential interest of organising on-going empowerment group–sessions, at close quarters, over the long term, in a heterogeneous socioeconomic environment. TRIAL REGISTRATION: ID_RCB number: 2011-A00046-35 Clinicaltrials.gov number: NCT01425866
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spelling pubmed-35375572013-01-10 Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island Debussche, Xavier Collin, Fidéline Fianu, Adrian Balcou-Debussche, Maryvette Fouet-Rosiers, Isabelle Koleck, Michèle Favier, François Cardiovasc Diabetol Study Protocol BACKGROUND: Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications. METHODS/DESIGN: ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomised in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age ≥18 years, type 2 diabetes treated for more than one year, HbA1c ≥ 7.5% for ≥3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of physical activity, food ingestion, quality of life, social support, anxiety, depression levels and self-efficacy. An associated nested qualitative study will be conducted with 30 to 40 subjects in order to analyse the learning and adaptation processes during the education cycles, and throughout the study. CONCLUSIONS: This research will help to address the necessary but difficult issue of structuring therapeutic education in type 2 diabetes based on: efficacy and potential interest of organising on-going empowerment group–sessions, at close quarters, over the long term, in a heterogeneous socioeconomic environment. TRIAL REGISTRATION: ID_RCB number: 2011-A00046-35 Clinicaltrials.gov number: NCT01425866 BioMed Central 2012-08-02 /pmc/articles/PMC3537557/ /pubmed/22856504 http://dx.doi.org/10.1186/1475-2840-11-91 Text en Copyright ©2012 Debussche et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Debussche, Xavier
Collin, Fidéline
Fianu, Adrian
Balcou-Debussche, Maryvette
Fouet-Rosiers, Isabelle
Koleck, Michèle
Favier, François
Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title_full Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title_fullStr Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title_full_unstemmed Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title_short Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island
title_sort structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ermies randomised trial in reunion island
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3537557/
https://www.ncbi.nlm.nih.gov/pubmed/22856504
http://dx.doi.org/10.1186/1475-2840-11-91
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