The Impact of Health Literacy–Sensitive Design and Heart Age in a Cardiovascular Disease Prevention Decision Aid: Randomized Controlled Trial and End-User Testing

BACKGROUND: Shared decision-making is an essential principle for the prevention of cardiovascular disease (CVD), where asymptomatic people consider lifelong medication and lifestyle changes. OBJECTIVE: This study aims to develop and evaluate the first literacy-sensitive CVD prevention decision aid (DA) developed for people with low health literacy, and investigate the impact of literacy-sensitive design and heart age. METHODS: We developed a standard DA based on international standards. The standard DA was based on our existing general practitioner DA. The literacy-sensitive DA included simple language, supporting images, white space, and a lifestyle action plan. The control DA used Heart Foundation materials. A randomized trial included 859 people aged 45-74 years using a 3 (DA: standard, literacy-sensitive, control) ×2 (heart age: heart age + percentage risk, percentage risk only) factorial design, with outcomes including prevention intentions and behaviors, gist and verbatim knowledge of risk, credibility, emotional response, and decisional conflict. We iteratively improved the literacy-sensitive version based on end-user testing interviews with 20 people with varying health literacy levels. RESULTS: Immediately after the intervention (n=859), there were no differences in any outcome among the DA groups. The heart age group was less likely to have a positive emotional response, perceived the message as less credible, and had higher gist and verbatim knowledge of heart age risk but not percentage risk. After 4 weeks (n=596), the DA group had better gist knowledge of percentage risk than the control group. The literacy-sensitive DA group had higher fruit consumption, and the standard DA group had better verbatim knowledge of percentage risk. Verbatim knowledge was higher for heart age than for percentage risk among those who received both. CONCLUSIONS: The literacy-sensitive DA resulted in increased knowledge of CVD risk and increased fruit consumption in participants with varying health literacy levels and CVD risk results. Adding heart age did not increase lifestyle change intentions or behavior but did affect psychological outcomes, consistent with previous findings. This tool will be integrated with additional resources to improve other lifestyle outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000806965; https://tinyurl.com/226yhk8a