Sun Ting, Zhao Huanhuan, Ding Zenghui, Xie Hui, Ma Linlin, Zhang Yu, Wang Yingying, Yang Yinju, Xu Chunyi, Sun Yining, Xu Xuejie, Ma Zuchang
Science Island Branch, University of Science and Technology of China, Hefei, China.
School of Nursing, Bengbu Medical College, Bengbu, China.
JMIR Res Protoc. 2023 Sep 12;12:e46883. doi: 10.2196/46883.
Hypertension is the most prevalent chronic condition and a significant risk factor for cardiovascular and kidney diseases. The efficacy of health behavioral interventions in blood pressure (BP) control has been demonstrated by a large and expanding body of literature, with "adherence" playing a crucial role. WeChat is the most common social communication mobile app in China, and it has been shown to be an acceptable delivery platform for delivering health interventions. The WeChat-based health behavioral digital intervention program (WHBDIP) showed high feasibility and efficacy. However, the results regarding BP improvement between the WHBDIP and control groups were inconsistent.
The objective of this study is to develop a WHBDIP and assess its efficacy in controlling BP and improving adherence among patients with hypertension.
A 2-arm, parallel-group, and randomized trial design was used. Patients older than 60 years and with hypertension were randomly assigned to either the control group or the experimental group, which received a 12-week intervention. The program, primarily developed based on the Behavior Change Wheel (BCW) theory, offers health education on exercise, diet, BP monitoring, and medicine adherence (MA). It also includes other behavior interventions guided by an intervention manual, incorporating behavior change techniques (BCTs). The primary outcomes encompass BP and adherence indicators, while the secondary outcomes encompass cardiovascular function indicators, body composition indicators, learning performance, satisfaction, and acceptability. The exercise and blood pressure monitoring adherence (BPMA) indicators for the WHBDIP group were assessed weekly via WeChat during the initial 3 months, while other outcome data for both groups will be collected at the baseline assessment phase, 3 months after the intervention, and 1 year after the program.
The trial will assess the efficacy of WHBDIP for patients with hypertension (N=68). The WHBDIP seeks to enhance participants' knowledge of healthy behaviors and assist patients in developing positive health behaviors to improve their health outcomes. Patient recruitment for individuals with hypertension commenced on September 5, 2022, and concluded on September 19, 2022. The 3-month intervention and phased data collection were finalized in January 2023. Data analysis will commence in August 2023, and the final 1-year health outcome results will be collected in September 2023.
A successful WHBDIP will establish the management mode as a feasible approach for hypertension management in the community. Additionally, it will pave the way for the development of related mobile health programs.
Chinese Clinical Trial Registry ChiCTR2200062643; https://tinyurl.com/mwyv67wk.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46883.
高血压是最常见的慢性病，也是心血管疾病和肾脏疾病的重要危险因素。大量且不断扩充的文献已证明健康行为干预在控制血压方面的有效性，其中“依从性”起着关键作用。微信是中国最常用的社交通讯移动应用程序，已被证明是实施健康干预的可接受平台。基于微信的健康行为数字干预项目（WHBDIP）显示出高度的可行性和有效性。然而，WHBDIP组与对照组在血压改善方面的结果并不一致。
本研究的目的是开发一种WHBDIP，并评估其在控制高血压患者血压和提高依从性方面的效果。
采用双臂、平行组随机试验设计。60岁以上的高血压患者被随机分配到对照组或试验组，试验组接受为期12周的干预。该项目主要基于行为改变轮（BCW）理论开发，提供有关运动、饮食、血压监测和药物依从性（MA）的健康教育。它还包括由干预手册指导的其他行为干预措施，纳入了行为改变技术（BCTs）。主要结局包括血压和依从性指标，次要结局包括心血管功能指标、身体成分指标、学习成绩、满意度和可接受性。在最初的3个月内，通过微信每周对WHBDIP组的运动和血压监测依从性（BPMA）指标进行评估，而两组的其他结局数据将在基线评估阶段、干预后3个月和项目结束后1年收集。
该试验将评估WHBDIP对高血压患者（N = 68）的疗效。WHBDIP旨在增强参与者对健康行为的认识，并帮助患者养成积极的健康行为以改善健康结局。高血压患者的招募于2022年9月5日开始，于2022年9月19日结束。为期3个月的干预和分阶段数据收集于2023年1月完成。数据分析将于2023年8月开始，最终的1年健康结局结果将于2023年9月收集。
一个成功的WHBDIP将确立这种管理模式为社区高血压管理的一种可行方法。此外，它将为相关移动健康项目的发展铺平道路。
中国临床试验注册中心ChiCTR2200062643；https://tinyurl.com/mwyv67wk。
国际注册报告识别号（IRRID）：PRR1-10.2196/46883。
