Department of Cardiology, Department of Library and Department of Clinical Epidemiology, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Department of Respiratory, Shengjing Hospital of China Medical University, Shenyang, 110004, People's Republic of China.
Trials. 2020 Feb 3;21(1):134. doi: 10.1186/s13063-020-4051-7.
Even though the effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention of hypertension and its complications have been demonstrated in randomized controlled trials, the benefits of adhering to these treatments have not been popularized among the general public. Studies suggest that incentive approaches based on behavioral economic concepts can improve patients' adherence to treatment. Therefore, we aimed to test whether financial incentives will reduce the blood pressure (BP) of hypertensive patients in China.
METHODS/DESIGN: This is a multicenter, randomized controlled trial with two parallel arms. A total of 400 participants from six cities in the Liaoning and Shanxi provinces of China are block-randomized into intervention and control group with a 1:1 ratio. Patients in the control group will receive interactive management of mobile devices, including patient education and communication. Patients in the intervention group will receive financial incentives in addition to interactive management of mobile devices, conditional on them achieving their antihypertensive goals or hypertension control. Masking the arm allocation will be precluded by the behavioral nature of the intervention and investigators of BP measurement and statistics are masked to clinic assignment. The primary outcome is net change in systolic BP (SBP) from baseline to month 12 between the intervention and control groups. The secondary outcomes are net change in diastolic BP (DBP), BP control, change in medication adherence and lifestyle, and cost-effectiveness.
This trial will determine whether financial incentives will improve hypertension control and generate necessary data for controlling hypertension and concomitant cardiovascular diseases among hypertensive patients in China.
ISRCTN13467677. Registered on 16 May 2019.
尽管生活方式改变和抗高血压药物治疗预防高血压及其并发症的有效性已在随机对照试验中得到证实，但这些治疗方法的益处尚未在公众中得到普及。研究表明，基于行为经济学概念的激励方法可以提高患者对治疗的依从性。因此，我们旨在检验在中国，经济激励是否会降低高血压患者的血压。
方法/设计：这是一项多中心、随机对照试验，有两个平行组。共有来自中国辽宁省和山西省六个城市的 400 名参与者按 1:1 的比例进行分组，随机分为干预组和对照组。对照组的患者将接受移动设备的互动管理，包括患者教育和沟通。干预组的患者除了接受移动设备的互动管理外，还将获得经济激励，前提是他们达到降压目标或控制高血压。由于干预措施的行为性质，将无法掩盖分组情况，而血压测量和统计的研究者也对诊所分配进行了掩盖。主要结局是干预组和对照组从基线到第 12 个月收缩压（SBP）的净变化。次要结局是舒张压（DBP）、血压控制、药物依从性和生活方式的变化以及成本效益的净变化。
这项试验将确定经济激励是否会改善高血压控制，并为中国高血压患者控制高血压和伴随的心血管疾病提供必要的数据。
ISRCTN83123506. 于 2019 年 5 月 16 日注册。
