Affiliation: | 1. Osakidetza, Active Patient Programme, Gros Health Centre, Avda Navarra 14, 20013 San Sebastián, Spain;2. Kronikgune-Research Centre on Chronicity, Torre del BEC, Ronda de Azkue, 1, 48902 Barakaldo, Bizkaia, Spain;3. Biodonostia Health Research Institute, Paseo Doctor Begiristain, 20014 San Sebastián, Spain;4. Research Unit, Primary Care-Organization of Integrated Health Services of Gipuzkoa, Paseo Doctor Begiristain, 20014 San Sebastián, Spain;5. REDISSEC-Health Services and Chronic Diseases Research Network, Spain;6. Osakidetza, Donostialdea Integrated Health Organization, Ondarreta Health Centre, C/Zumalakarregi 24, 20008 San Sebastián, Spain;7. Primary Care Research Unit of Bizkaia, C/ Luis Power 18 planta 4, 48014 Bilbao, Spain;8. Osakidetza, Donostialdea Integrated Health Organization, Gros Health Centre, Avenida de Navarra 14, 20013 San Sebastián, Spain;9. Osakidetza, Donostialdea Integrated Health Organization, Bidebieta Health Centre, Paseo Julio Urkijo s/n, 20016 Donostia, Spain;10. O + Berri, Basque Institute for Healthcare Innovation, Torre del BEC (Bilbao Exhibition Centre), Ronda de Azkue 1, 48902 Barakaldo, Bizkaia, Spain;11. Family Medicine and Community Teaching Unit of Bizkaia, C/ Luis Power 18 planta 4, 48014 Bilbao, Spain;12. Osakidetza, Araba Integrated Health Organization, Olaguibel Health Centre, C/ Olaguibel 31, 01004 Vitoria-Gasteiz, Spain;13. Osakidetza, Ezkerraldea Enkarrterri Cruces Integrated Health Organization, Ortuella Health Centre, Avenida Minero s/n, 48530 Ortuella, Bizkaia, Spain;14. Osakidetza, Bidasoa Integrated Health Organization, Hondarribia Health Centre, C/ Matxin de Arzu no 2, 20280 Hondarribia, Gipuzkoa, Spain;15. Osakidetza, Donostialdea Integrated Health Organization, Alza Health Centre, Paseo de Larratxo 95, 20017 San Sebastián, Spain |
Abstract: | AimThe 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.MethodsA 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.Resultsn=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.ConclusionHbA1c 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 |