Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure

BACKGROUND: To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardiovascular disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, only one-third of hypertensive patients are adequately treated, with regards to national clinical guidelines. One reason for this problem is low treatment adherence; tools with documented effects for increasing adherence of patients are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: ‘Your Heart Forecast’ (YHF) on blood pressure control, primary non-compliance, health literacy and patient empowerment. METHODS: Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. DISCUSSION: The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to YHF with the national databases of prescriptions and health services provided. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04058847. Registered on 16 August 2019.