China Oxford Centre for International Health Research, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Center for Outcomes Research and Evaluation, Yale University/Yale-New Haven Hospital, New Heaven, Connecticut, USA.
BMJ Open. 2017 Dec 21;7(12):e018302. doi: 10.1136/bmjopen-2017-018302.
Mobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes.
The Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP <140 mm Hg, low-density lipoprotein cholesterol (LDL-C), physical activity, medication adherence, body mass index (BMI) and smoking cessation. In CHAT-DM, the primary outcome is the change in glycaemic haemoglobin (HbA) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA<7%, fasting blood glucose, SBP, LDL-C, BMI, physical activity and medication adherence.
The central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications.
CHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.
移动健康干预措施有可能促进危险因素管理和生活方式的改变，对于资源有限的医疗系统来说，这是一种特别有吸引力的扩大规模的方法。我们正在进行两项随机试验，以评估基于短信的健康信息在改善伴有或不伴有糖尿病的冠心病（CHD）患者二级预防中的效果。
心血管健康与短信（CHAT）研究和 CHAT-糖尿病（CHAT-DM）研究是在中国 17 个省的 37 家医院进行的多中心、单盲、随机对照试验，比较了短信干预与标准治疗的效果，随访时间为 6 个月。干预组每周接收 6 条短信，针对血压控制、药物依从性、身体活动、戒烟（如有需要）、血糖监测和生活方式建议，包括饮食（在 CHAT-DM 中）。短信是根据行为改变技术开发的，使用信息动机行为技能模型、目标设定和提供社会支持等模型。CHAT 研究的总样本量为 800 例患者即可，CHAT-DM 研究的样本量为 500 例患者即可。在 CHAT 中，主要结局是 6 个月时收缩压（SBP）的变化。次要结局包括达到 SBP<140mmHg 的患者比例变化、低密度脂蛋白胆固醇（LDL-C）、身体活动、药物依从性、体重指数（BMI）和戒烟的变化。在 CHAT-DM 中，主要结局是 6 个月时糖化血红蛋白（HbA）的变化。次要结局包括达到 HbA<7%、空腹血糖、SBP、LDL-C、BMI、身体活动和药物依从性的患者比例变化。
中国国家心血管病中心中央伦理委员会和耶鲁大学机构审查委员会批准了 CHAT 和 CHAT-DM 研究。结果将通过包括同行评议出版物在内的常规科学论坛进行传播。
CHAT（NCT02888769）和 CHAT-DM（NCT02883842）；预结果。
