Gamboa Moreno Estibaliz, Mateo-Abad Maider, Ochoa de Retana García Lourdes, Vrotsou Kalliopi, Del Campo Pena Emma, Sánchez Perez Álvaro, Martínez Carazo Catalina, Arbonies Ortiz Juan Carlos, Rúa Portu M Ángeles, Piñera Elorriaga Koldo, Zenarutzabeitia Pikatza Amaya, Urquiza Bengoa Miren Nekane, Méndez Sanpedro Tomás, Oses Portu Ana, Aguirre Sorondo Miren Bakarne, Rotaeche Del Campo Rafael
Osakidetza, Active Patient Programme, Gros Health Centre, Avda Navarra 14, 20013 San Sebastián, Spain; Kronikgune-Research Centre on Chronicity, Torre del BEC, Ronda de Azkue, 1, 48902 Barakaldo, Bizkaia, Spain; Biodonostia Health Research Institute, Paseo Doctor Begiristain, 20014 San Sebastián, Spain.
Research Unit, Primary Care-Organization of Integrated Health Services of Gipuzkoa, Paseo Doctor Begiristain, 20014 San Sebastián, Spain; Kronikgune-Research Centre on Chronicity, Torre del BEC, Ronda de Azkue, 1, 48902 Barakaldo, Bizkaia, Spain; Biodonostia Health Research Institute, Paseo Doctor Begiristain, 20014 San Sebastián, Spain.
Prim Care Diabetes. 2019 Apr;13(2):122-133. doi: 10.1016/j.pcd.2018.10.001. Epub 2018 Nov 6.
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.
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.
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.
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.
ClinicalTrials.gov identifier NCT01642394.
本研究旨在评估西班牙糖尿病自我管理项目（SDSMP）与常规护理相比，对居住在西班牙某地区的2型糖尿病（T2DM）成年患者的疗效。
一项为期两年的随访随机对照试验。干预措施包括6次每周一次的结构化同伴互助工作坊。主要结局是糖化血红蛋白（HbA1c）水平的变化。次要结局包括其他临床指标、生活质量、自我效能感、生活方式改变、药物治疗及医疗服务使用情况。采用混合效应模型。
每个研究组招募了n = 297例患者。两组的基线HbA1c水平相当，总体均值为7.1（标准差=1.2）。干预措施并未显著改变HbA1c或其他心血管变量。自我效能感有显著改善，尤其是其疾病控制方面。在医疗资源使用和药物消费方面也观察到了某些差异。工作坊参与率和满意度较高。
在病情得到充分控制的患者中，很难实现HbA1c的降低。另一方面，提高对自身疾病的认识可以增强疾病控制自我效能感。这一发现，再加上药物消费和医疗使用率的降低，凸显了将SDSMP的某些方面纳入常规护理会带来益处。
ClinicalTrials.gov标识符NCT01642394。
