Digital health interventions – how are we going with evidence?

RCTs and variance in clinical outcomes and patient preferences

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Major advances in internet and mobile technology over the past decade provide potential solutions to improve outcomes and broaden the reach of health care. Worldwide, more than five billion people own mobile phones1 and opportunities to deliver healthcare digitally are expanding exponentially with strategies such as internet portals, data-driven precision medicine and smartphone applications (apps).2 In our recent paper published in npj Digital Medicine we present the results of a large primary care RCT (CONNECT) where we tested effectiveness of an integrated and responsive web-app for supporting patients manage cardiovascular disease.3

For our large trial in primary care, we used a co-design process to develop the software and then recruited 934 patients with, or at risk of, cardiovascular disease.3 Primary outcome was proportion of participants taking guideline-recommended medicines and there was no significant difference between the groups at follow-up. There were however, significant improvements physical activity and e-health literacy scores in the intervention group. Interestingly, qualitative research was largely very positive.4 For example, 40% of participants reported the web-app improved their mental health and well-being, 47% reported higher physical activity levels and 61% reported healthier eating.4 In addition, 73% of intervention participants reported benefiting from personalized cardiovascular disease risk score and 52% benefited from the risk factor self-monitoring.4

 In the CONNECT study, it was concluded that a consumer app integrated with primary health care electronic health records was not effective in increasing medication adherence but was associated with some improvements in risk factors and modest behavior change. However, the results highlight an important and fundamental question. Are RCTs with traditional primary outcomes the best way to determine potential effectiveness and usefulness for consumers/patients? In our study, there was clear disparity between the objective clinical outcomes and patient preferences. It is essential that we consider the importance and relevance of outcome measures to consumers/patients. This is area within clinical trials is often overlooked but is more important than ever when developing and testing digital health interventions. We propose that further research that helps the scientific community understand how future studies can ensure emphasis on outcomes that are of high value to patients but are also scientifically robust so we can most effectively estimate the potential benefits of digital health interventions that are consumer-directed.

 References

  1. Number of smartphone users worldwide from 2016 to 2021 (in billions). https://www.statista.com/statistics/330695/number-of-smartphone-users-worldwide/ (Accessed 26 Aug 2019).
  2. Neubeck L et al. The mobile revolution--using smartphone apps to prevent cardiovascular disease. Nat Rev Cardiol 12, 350–60 (2015).
  3. Redfern J, Coorey G, Mulley J et al. A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial. npj Digit. Med 3, 117 (2020). https://doi.org/10.1038/s41746-020-00325-z
  4. Coorey G et al. Persuasive design features within a consumer-focused eHealth intervention integrated with the electronic health record: a mixed methods study of effectiveness and acceptability. PloS One 14, e0218447 (2019).

Julie Redfern

Professor of Public Health, University of Sydney

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