Danish evaluation of Your Heart Forecast: a cluster randomised controlled trial aimed at improving modifiable risk factors of CVD

OBJECTIVES: To evaluate if an intervention to improve health literacy, using the risk communication tool 'Your Heart Forecast' and informative e-mails, can lower patients' blood pressure (BP) and total cholesterol to high-density lipoprotein ratio (TC/HDL).

DESIGN: A cluster randomised controlled trial.

SETTING: The intervention took place in 17 Danish general practice clinics randomised to either control or intervention at clinic level after invitation of each 25 hypertensive patients by birthdate.

PARTICIPANTS: Men and women were eligible for inclusion if 35-75 years old, without prior cardiovascular disease (CVD). The final population consisted of 255 patients, 142 intervention and 113 control. The 146 men and 109 women were included between April 2019 and May 2021. The trial ended in March 2022.

INTERVENTION: The intervention consisted of the CVD-risk communication tool 'Your Heart Forecast' at the annual BP consultations plus 1 monthly educational e-mail on lifestyle for 12 months. The control group received the usual care, defined as the annual CVD risk management consultation.Main outcome measures, BP and TC/HDL, were measured at baseline and follow-up after 10-18 months. Patients were divided into groups based on baseline levels and a paired t-test was performed on a pseudorandomised dataset by a blinded statistician.

RESULTS: Both groups' most dysregulated patients decreased their BP (p<0.0001, p=0.0002), and the BP decrease in the intervention group was larger. Additionally, the intervention patients with moderately raised BP also decreased their BP significantly (p=0.0133). Both groups saw an increase in BP in the most well-regulated patients. TC/HDL decreased only for the intervention patients with the highest baseline levels (p<0.0001) and increased for all with the lowest ratio (p<0.0001).

CONCLUSION: The intervention lowered BP and TC/HDL in comparison to usual care for patients with dysregulated BP and/or TC/HDL above 4.

TRIAL REGISTRATION NUMBER: NCT04058847; Clinicaltrials.gov, registered on 16 August 2019.