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Open Access Highly Accessed Study protocol

Impact of a self-care education programme on patients with type 2 diabetes in primary care in the Basque Country

Estibaliz Gamboa Moreno1*, Álvaro Sánchez Perez2, Kalliopi Vrotsou3, Juan Carlos Arbonies Ortiz4, Emma del Campo Pena4, Lourdes Ochoa de Retana Garcia1, María Ángeles Rua Portu5, Koldo Piñera Elorriaga6, Amaya Zenarutzabeitia Pikatza7, Miren Nekane Urquiza Bengoa8, Rosario Sanz Echave1, Tomás Méndez Sampedro9, Ana Oses Portu10, Lourdes Gorostidi Fano10, Miren Bakarne Aguirre Sorondo3, Rafael Rotaeche Del Campo11 and In the name of the Osakidetza Active Patient Research Group

Author Affiliations

1 Pasajes San Pedro Health Centre, Osakidetza, c/ Marinos nº 1, Pasajes San Pedro, Gipuzkoa 20110, Spain

2 Primary Care Research Unit of Bizkaia, Osakidetza, c/ Luis Power 18 planta 4, Bilbao 48014, Spain

3 Primary Care Research Unit of Gipuzkoa, Osakidetza, Pº Doctor Begiristain, Donostia s/n 20014, Spain

4 Beraun Health Centre, Osakidetza, Av. Galtzaraborda 67, Renteria, Gipuzkoa, Spain

5 Bidebieta Health Centre, Osakidetza, Pº Julio Urkijo, San Sebastián, Gipuzkoa s/n - 20016, Spain

6 O + Berri, Fundación Vasca de Innovación e Investigación Sanitarias, Plaza Asua, 1. 48150, Sondika, Bizkaia, Spain

7 Unidad Docente de Medicina familiar y Comunitaria de Bizkaia, Osakidetza, c/ Luis Power 18 planta 4, 48014, Bilbao, Spain

8 Gazalbide-Txagorritxu Health Centre, Osakidetza, c/ Chile, 9-01009, Vitoria-Gasteiz, Spain

9 Ortuella Health Center, Osakidetza, Avda. Minero, Ortuella, Bizkaia s/n - 48530, Spain

10 Hondarribia Health Center, Osakidetza, c/ Matxin de Arzu nº 2, Hondarribia, Gipuzkoa 20280, Spain

11 Alza Health Centre, Osakidetza, Paseo de Larratxo 95, San Sebastián, Spain

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BMC Public Health 2013, 13:521  doi:10.1186/1471-2458-13-521

Published: 29 May 2013

Abstract

Background

Type 2 diabetes mellitus (DM2) is a disease with high prevalence and significant impact in terms of mortality and morbidity. The increased prevalence of the disease requires the implementation of new strategies to promote patient self-management. The Spanish Diabetes Self-Management Program (SDSMP) has proven to be effective in other settings. The objective of this study is to assess its effectiveness in terms of care for DM2 patients in primary care settings within the Basque Health Service – Osakidetza (Spain).

Method/Design

This is a randomised clinical trial in which patients diagnosed with DM2, 18–79 years of age, from four health regions within the Basque Health Service will be randomised into two groups: an intervention group, who will follow the SDSMP, and a control group, who will receive usual care in accordance with the clinical guidelines for DM2 and existing regulations in our region. The intervention consists of 2,5 hour-group sessions once a week for six weeks. The sessions cover target setting and problem solving techniques, promotion of physical exercise, basic knowledge of nutrition, proper use of medication, effective communication with relatives and health professionals, and basic knowledge about DM2 and its complications. This content is complemented by educational material: books, leaflets and CDs. The primary outcome measure will be the change in glycated haemoglobin (HbA1c), and secondary outcome measures will include changes in levels of physical activity and intake of fruit and vegetables, cardiovascular risk, quality of life, self-efficacy, number of consultations and drug prescriptions. The results will be analysed 6, 12 and 24 months after the intervention.

Discussion

If the intervention were to be effective, the programme should be spread to the entire diabetic population in the Basque Country and it could also be applied for other diseases.

Trial registration

ClinicalTrials.gov identifier NCT01642394

Keywords:
Chronic disease; Diabetes Mellitus type 2; Self-management; Education; Primary care