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

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.