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.

Efficacy of a self-management education programme on patients with type 2 diabetes in primary care: A randomised controlled trial.

AIM: The purpose of this study was to assess the efficacy of the Spanish Diabetes Self-Management Program (SDSMP) versus usual care in adults with type 2 diabetes mellitus (T2DM) residing in a Spanish region. METHODS: A two-year follow-up randomised controlled trial. The intervention consisted of 6 weekly structured peer-to-peer workshops. The primary outcome was change in HbA1c levels. Secondary outcomes included other clinical measures, quality of life, self-efficacy, life-style changes, medication and use of healthcare services. Mixed effect models were fitted. RESULTS: n=297 patients were recruited in each study arm. Baseline HbA1c levels were comparable in both groups with an overall mean 7.1 (SD=1.2). The intervention did not significantly modify HbA1c, or other cardiovascular variables. Significant improvements were seen in self-efficacy, and in particularly its disease control component. Certain differences were also observed in the use of healthcare resources and medication consumption. High workshop participation and satisfaction rates were achieved. CONCLUSION: HbA1c reductions are difficult to obtain in adequately controlled patients. On the other hand, raising awareness on one's disease can increase disease control self-efficacy. This finding, accompanied by reduced medication consumption and healthcare use rates, highlights that usual care would be benefited by incorporating certain SDSMP aspects. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01642394.

A Pilot Study to Assess the Feasibility of the Spanish Diabetes Self-Management Program in the Basque Country.

Purpose. The purpose of this study was to assess the feasibility of the Spanish Diabetes Self-Management Program (SDSMP) in the primary care setting of the Basque Health Service and offer initial estimations of the randomized controlled trial (RCT) effects. Methods. Ten health centers (HCs) participated in a single-arm pilot study with a 6-month follow-up period between February 2011 and June 2012. Recruitment was performed via invitation letters, health professionals, and the local media. Each intervention group consisted of 8-15 people. The ability of each HC in forming up to 2 groups, participants' compliance with the course, and coordination and data collection issues were evaluated. Glycated haemoglobin (HbA1c) was the main outcome variable. Secondary outcomes were cardiovascular risk factors, drugs consumption, medical visits, quality of life, self-efficacy, physical exercise, and diet. Results. Two HCs did not organize a course. A total of 173 patients initiated the program, 2 dropped out without baseline data, and 90% completed it. No pre-post HbA1c differences existed. Certain improvements were observed in blood pressure control, self-efficacy, physical activity, and some dietary habits. Conclusion. The SDSMP is feasible in our setting. Our experience can be of interest when planning and conducting this program in similar health settings. The trial is registered with ClinicalTrials.gov identifier NCT01642394.