A behavior change wheel-based interactive pictorial health education program for hypertensive patients with low blood pressure health literacy: study protocol for a randomized controlled trial

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinical Trials.gov Protocol Registration and Results System ID NCT04327102 . Prospectively registered on February 29, 2020.