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Open Access Study protocol

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

Xavier Debussche127*, Fidéline Collin3, Adrian Fianu2, Maryvette Balcou-Debussche45, Isabelle Fouet-Rosiers13, Michèle Koleck6 and François Favier2

Author Affiliations

1 Metabolic and Chronic Diseases Department, Endocrinology, Diabetology and Nutrition Unit, CHU of La Reunion, Saint-Denis, La Reunion, France

2 Centre for Clinical Investigation-Clinical Epidemiology (CIC-EC INSERM/CHU/University), CHU of La Réunion, Saint-Pierre/Saint-Denis, La Reunion, France

3 Clinical Research and Innovation Department, CHU of La Reunion, La Reunion, France

4 LCF (Languages, texts and communication in Creole and French speaking spaces), CNRS- UMR 8143, IUFM-University of La Reunion, Saint-Denis, La Reunion, France

5 UNiRès, UNiversities/IUFM network for health education, Blaise Pascal University, Clermont-Ferrand II, Chamallières, France

6 Health Psychology laboratory, EA 487, Victor Segalen University (Bordeaux 2), Bordeaux, France

7 Diabétologie- Endocrinologie, Hôpital Félix Guyon, CHU de la Réunion, 97405 Saint-Denis, Cedex, France

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Cardiovascular Diabetology 2012, 11:91  doi:10.1186/1475-2840-11-91

Published: 2 August 2012

Abstract

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

Keywords:
Randomised controlled trial; Self-management education; Type 2 diabetes; Learning nests; Reunion Island