Abstract
BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN13467677. Registered on 16 May 2019.