P5307A consumer-direct digital health intervention for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised controlled trial

Abstract Background Digital health interventions linked to electronic health records offer patients an innovative approach to support cardiovascular disease (CVD) risk management. Purpose Test the effectiveness of a consumer-directed digital health strategy on medication adherence and cardiovascular health outcomes in patients presenting to primary care who are at moderate to high risk of CVD. Methods Randomised controlled trial (RCT) with 12 month follow-up. Intervention group received an interactive digital health strategy for CVD management. The intervention was integrated with patient's electronic health record to enable automated population of risk factor and medication data (Figure). Control group received usual care. Primary outcome was the proportion of patients taking guideline-recommended BP and cholesterol-lowering medications on at least 80% of days (administrative data). Secondary outcomes included mean SBP, LDL-cholesterol, BMI and proportion meeting risk targets for physical activity, achieving smoking cessation, quality of life (EQ5D) and ehealth literacy (eHEALS). Results Intervention (n=486) and control (n=448) groups were well matched at baseline (Table). Mean age of participants was 67±8.1 years, 77% were male, 41% had existing CVD. At 12 months, there was no significant difference between the groups for medication days covered or mean cholesterol and BP (Table). However, there were significantly more patients in the intervention than control group who were physically active and had high ehealth literacy (Table). Table 1. Primary and Secondary Outcomes Baseline 12 months Outcome Control (n=448) Intervention (n=486) Control (n=431) Intervention (n=460) p value* Taking BP and cholesterol medication on ≥80% of days, % 29.7 28.9 29.9 32.8 0.485 SBP (mmHg), mean±SD 139.0±16.6 137.3±15.9 136.3±16.1 136.4±17.6 0.921 LDL (mmol/L), mean±SD 2.6±1.0 2.6±1.0 2.5±0.9 2.4±1.0 0.240 BMI (kg/m2), mean±SD 29.7±5.1 29.9±5.7 29.4±5.0 29.7±5.7 0.508 Proportion achieving BP and LDL target, % 11.2 12.3 11.7 16.5 0.065 Physically active, % 84.0 85.4 79.7 87.0 0.016 Current smoker, % 12.9 13.0 12.0 8.1 0.087 eHEALS, mean±SD 27.0±6.4 27.0±6.4 26.4±7.5 28.3±6.3 0.002 *Comparing intervention and control at 12 month follow-up. Conclusions The integrated digital health strategy did not significantly impact on days of medication covered however, patients in the intervention had higher physical activity and ehealth literacy. The RCT highlights the importance of conducting robust research if we are to understand the potential value of digital health interventions. Acknowledgement/Funding This work was supported by a Project Grant from the National Health and Medical Research Council of Australia