School of Medicine & Nursing Sciences, HuZhou University, Huzhou, Zhejiang, China.
Present address: Department of Nursing, Jiangxi Medical College, Shangrao, Jiangxi, China.
Trials. 2022 May 3;23(1):369. doi: 10.1186/s13063-022-06300-1.
The prevalence of hypertension is increasing worldwide. Hypertension self-management usually involves the application and consideration of oral, written, or quantitative information. Hypertensive patients in China have limited high blood pressure health literacy (HBP-HL), which may lead to poorer clinical outcomes. This study aims to determine the feasibility and effectiveness of an interactive pictorial health education program based on behavior change wheel (BCW) theory and its effect on HBP-HL, self-efficacy, self-management ability, and health-related quality of life (HRQOL) in hypertensive patients with low HBP-HL.
This study is a randomized controlled trial (RCT). One of the municipal districts in Huzhou, China, will be randomly selected, and two communities with similar conditions within this district will be screened and selected. A total of 120 hypertensive patients aged 18 years and older will be recruited from these two community settings. One of the communities will be randomly allocated to an interactive pictorial health education program conducted by a comprehensive health literacy strategy that includes (i) training participants in effective health communication skills that address issues encountered in seeking medical care and (ii) the use of self-developed interactive pictorial hypertension education to improve patient understanding and behaviors versus a control group (routine community lecture health education only). The primary outcome measure is HBP-HL. Secondary outcomes are self-efficacy, self-management ability, HRQOL, social support, and improvement in blood pressure. Outcomes will be collected at 6, 9, and 12 months from trial entry.
The strengths of this study are the establishment of a new health management program for hypertensive patients that closely combines BCW theory and health literacy. This trial has the potential to improve HBP-HL in hypertensive Chinese patients with low health literacy to improve the self-management of hypertension and help control blood pressure.
Clinical Trials.gov Protocol Registration and Results System ID NCT04327102 . Prospectively registered on February 29, 2020.
高血压的患病率在全球范围内呈上升趋势。高血压自我管理通常涉及口头、书面或定量信息的应用和考虑。中国的高血压患者健康素养(HBP-HL)有限,这可能导致较差的临床结局。本研究旨在确定基于行为改变轮(BCW)理论的互动图片健康教育计划的可行性和有效性,及其对 HBP-HL、自我效能、自我管理能力和高血压患者健康相关生活质量(HRQOL)的影响。
这是一项随机对照试验(RCT)。中国湖州市的一个市级行政区将被随机选择,该行政区内具有相似条件的两个社区将被筛选和选择。总共将从这两个社区环境中招募 120 名年龄在 18 岁及以上的高血压患者。其中一个社区将被随机分配到一个互动图片健康教育计划中,该计划采用综合健康素养策略,包括(i)培训参与者有效的医疗保健沟通技巧,以解决在寻求医疗保健时遇到的问题;(ii)使用自行开发的互动图片高血压教育来提高患者的理解和行为,而对照组则仅接受常规社区讲座健康教育。主要结局指标是 HBP-HL。次要结局指标是自我效能、自我管理能力、HRQOL、社会支持以及血压改善。结果将在试验开始后 6、9 和 12 个月进行收集。
本研究的优势在于建立了一种新的高血压患者健康管理方案,该方案紧密结合了 BCW 理论和健康素养。该试验有可能提高中国低健康素养高血压患者的 HBP-HL,以改善高血压的自我管理,帮助控制血压。
ClinicalTrials.gov 方案注册和结果系统 ID NCT04327102。于 2020 年 2 月 29 日前瞻性注册。