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01.12.2012 | Study protocol | Ausgabe 1/2012 Open Access

Cardiovascular Diabetology 1/2012

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

Zeitschrift:
Cardiovascular Diabetology > Ausgabe 1/2012
Autoren:
Xavier Debussche, Fidéline Collin, Adrian Fianu, Maryvette Balcou-Debussche, Isabelle Fouet-Rosiers, Michèle Koleck, François Favier
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2840-11-91) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

XD was the initiator for this study, XD, FC and AF drafted the study protocol. XD organised the recruitment of the centres. XD, FF, AF, and MK developed the questionnaires, FC, AF, FF organised the data collection and management and the administration of the whole study. MBD and XD developed the SME programme; MBD drafted the protocol of the nested qualitative study. AF conducted the power calculation, supervised the analyses and gave statistical and methodological input. IFR and XD are the organisers of the nurses' education course and patient self-management group education follow-up. XD, FC and AF wrote and revised the final manuscript, and all authors read and approved it.

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
Zusatzmaterial
Authors’ original file for figure 1
12933_2012_565_MOESM1_ESM.pdf
Literatur
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