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Open Access Study protocol

Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

Alvaro Sanchez1*, Carmen Silvestre2, Regina Sauto3, Catalina Martínez1, Gonzalo Grandes1 and on behalf of the PreDE research group

Author affiliations

1 Primary Care Research Unit – Bizkaia, Basque Health Service, Osakidetza, Spain

2 Quality Unit, Gipuzkoa Health Region, Osakidetza, Spain

3 The Basque Institute for Healthcare Innovation (O+berri), Osakidetza, Spain

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Citation and License

BMC Family Practice 2012, 13:109  doi:10.1186/1471-2296-13-109

Published: 16 November 2012

Abstract

Background

The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza.

Methods/design

This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation.

Discussion

The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.

Trial registration

ClinicalTrials.gov NCT01365013

Keywords:
Pre-diabetes; Primary health care; Prevention; Clinical trial