A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial

“Our randomized controlled trial (RCT) found a physician-focused decision support tool to be effective in increasing CVD risk assessment when embedded within the primary care clinical record system. In particular, personalized risk score information that is explained on a visually interesting interface, can make the impact of improving biometric risk factor values (for example, blood pressure), or behaviors (for example, smoking cessation), more compelling. Hypothesized as a useful springboard to more engagement by patients with CVD risk factor control, the concept was adapted to a consumer-facing resource in the current trial. Other trials have demonstrated the benefits of apps for improving medication adherence and text messages for cardiovascular risk reduction.

[..] In total, 7457 potentially eligible patients were identified using the primary care EHR and 3905 were excluded by their GP. We approached 3552 patients, 2618 did not meet eligibility criteria or declined participation and 934 were enrolled and randomized.

[..] Overall, 93% (451/486) of intervention group participants commenced use of the intervention. Thereafter, participants were classified as non-adopters (no logins after the training session—13%, 58/451), low-users (at least one login any across any 3 months of the follow-up period—47%, 211/451) or high-users (at least one login in any 4 months of the follow-up period—40% 182/451). Adherence to guideline recommended medications did not differ significantly between levels of intervention use (p = 0.44). At 12 months, the intervention group had a non-significant higher proportion of participants achieving the primary outcome of ≥80% medication days covered than in the control group (32.8% vs. 29.9%; RR 1.07 [95% CI 0.88–1.20]). The relative risk was broadly unchanged when adjusted in multivariate analyses for age, sex, and diabetes status. There were no significant differences between the control and intervention groups on the primary outcome for any of our pre-specified sub-groups of gender, age, baseline eHEALS, and CVD subgroups.

[..] At 12 months, there was a borderline improvement in BP and LDL control rates in intervention vs. control (17.1% vs. 12.1%, RR 1.41 95% CI 0.98–2.03), however control rates remained low overall in both study arms. There were no significant differences between the intervention and control groups in mean LDL cholesterol (2.5 vs. 2.4 mmol/L, mean difference −0.08 mmol/L, 95% CI −0.22 to 0.05) and SBP (136.3 vs. 136.4 mmHg, mean difference 0.12 mmHg, 95% CI −2.21 to 2.45). For lifestyle behaviors, there were significantly more participants meeting recommended levels for physical activity (87 vs 79.7%, p = 0.02) in the intervention than the control group. There were no significant differences in any of other lifestyle-related behaviors including quality of life scores and HLQ [Health Literacy Questionnaire] scores.”

Full article, Redfern J, Coorey G, Mulley J et al. npj Digital Medicine 2020.9.10