National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland 1142, New Zealand
National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland 1142, New Zealand.
BMJ. 2018 May 17;361:k1959. doi: 10.1136/bmj.k1959.
To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes.
Nine month, two arm, parallel randomised controlled trial.
Primary and secondary healthcare services in New Zealand.
366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ≥65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control).
The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system.
Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity.
The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes.
A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population.
Australian New Zealand Clinical Trials Registry ACTRN12614001232628.
确定一种基于理论且针对个体差异的、基于短信的糖尿病自我管理支持干预措施（SMS4BG）在血糖控制不佳的糖尿病患者中的有效性。
9 个月、双臂、平行随机对照试验。
新西兰的初级和二级医疗保健服务机构。
2015 年 6 月至 2016 年 11 月期间，随机分为 183 名干预组和 183 名对照组，共 366 名年龄在 16 岁及以上、血糖控制不佳的 1 型或 2 型糖尿病患者（HbA1c≥65mmol/mol或 8%）。
干预组在常规治疗的基础上接受了长达 9 个月的个性化短信套餐。短信提供了与糖尿病自我管理和生活方式行为相关的信息、支持、动机和提醒。对照组接受常规护理。信息由专门设计的自动化内容管理系统发送。
主要结局指标为从基线到 9 个月时的血糖控制变化（HbA1c）。次要结局指标包括 3 个月和 6 个月时的 HbA1c 变化，以及自我效能、糖尿病自我护理行为、糖尿病困扰、对糖尿病的认知和信念、健康相关生活质量、对糖尿病管理的感知支持、以及 9 个月时的干预参与度和满意度。回归模型调整了基线结局、卫生区类别、糖尿病类型和种族。
干预组 9 个月时 HbA1c 的降低幅度明显大于对照组（平均 -8.85mmol/mol（14.84）与 -3.96mmol/mol（17.02）；调整后的平均差异-4.23（95%置信区间-7.30 至-1.15），P=0.007）。在 21 项次要结局中，只有 4 项在 9 个月时显示出有利于干预组的统计学显著改善。干预组在足部护理行为（调整后的平均差异 0.85（95%置信区间 0.40 至 1.29），P<0.001）、总体糖尿病支持（0.26（0.03 至 0.50），P=0.03）、EQ-5D 视觉模拟量表上的健康状况（4.38（0.44 至 8.33），P=0.03）和疾病认同感知（-0.54（-1.04 至-0.03），P=0.04）方面有显著改善。SMS4BG 的满意度很高，169 名参与者中有 161 名（95%）报告其有用，164 名（97%）愿意向其他糖尿病患者推荐该项目。
一种基于个性化、短信的自我管理支持计划可使血糖控制不佳的糖尿病患者的血糖控制得到适度改善。尽管这些结果的临床意义尚不清楚，但研究结果支持进一步调查 SMS4BG 及其他基于短信的支持措施在这一患者群体中的应用。
澳大利亚新西兰临床试验注册 ACTRN12614001232628。
