How clinical trials support digital health acceptance

Using ICT to improve outcomes in patients, digital health (eHealth in short) makes health care more effective, affordable and more manageable. 

As a research organisation, we’re working to get eHealth widely recognised by clearly demonstrating its added value through clinical trials and studies.

Facilitating digital health studies

Since 2014, Leonie has been coordinating cardiovascular related research with a special focus on eHealth.

Leonie shares: “We started with the TeleCaRe study, a single centre randomised controlled trial in Isala Heart Centre Zwolle, The Netherlands, that ran from 2014 till 2016. The aim was to assess whether an extension of the cardiac rehabilitation program with telemonitoring guidance resulted in better acute and long term effects on physical and mental outcomes than a regular follow-up period after traditional cardiac rehabilitation.”

Results showed that extending cardiac rehabilitation with telerehabilitation was equally effective as traditional follow-up through monthly phone calls.

Optimising the process

eHealth should be as accessible as possible.

But apart from the clinical results, there is much more to gain from digital health studies: important learnings to optimise the process.

Leonie elaborates: “With the TeleCaRe study, patients received a dedicated smartphone with the necessary applications. But some patients didn’t want to carry an extra phone and heart rate belt. Others had trouble using technical equipment, it proved difficult for them having to press several buttons or getting it all connected.”

“Running TeleCaRe showed us, that in order for eHealth to work, it should be as accessible as possible for patients; an invaluable learning we incorporated into the follow-up trial EU-CaRE RCT,” says Leonie.

eHealth as alternative strategy for nonparticipation

Home-based care in combination with novel eHealth applications is an effective alternative for these patients who decline participation in cardiac rehabilitation.

EU-CaRE RCT was a multicenter (6 centers), multinational (5 countries), randomized controlled trial for a digital health application in cardiac rehabilitation in Europe. The project was funded by the Horizon 2020 Framework Programme of the European Union and the government of Switzerland and ran from 2015 till 2019.

Although nonparticipation in cardiac rehabilitation is known to increase cardiovascular mortality and hospital readmissions, more than half of patients with coronary artery disease in Europe are not participating in cardiac rehabilitation.

Leonie: “Although necessary, participating in a cardiac rehabilitation (CR) programme isn’t always a given for elderly patients. For example, some people are done with being a patient and want to move on. Others don’t have the means to travel to the hospital, either financially or physically.

With EU-CaRE RCT, we wanted to overcome these barriers to participate in CR and research if home-based care in combination with novel eHealth applications (where guidance from distance is enabled) would be an effective alternative for these patients who decline participation.”

Results were positive, suggesting that a home-based mobile telemonitoring guided CR (mCR) program for patients 65 years or older was safe and beneficial when compared with no cardiac rehabilitation.

Navigating digital challenges

Strong data management is crucial for a successful eHealth trial.

Novel health tools bring novel challenges. Leonie shares: “We ask patients to operate modern devices, so it does require a certain level of tech savviness.”

“Another challenge we encountered, is handling the incredible amount of data that becomes available and keeping this data safe and confidential,” Leonie says. “There’s a standard trial database, but with digital health studies you also receive data from digital devices like a smartphone. You encounter completely new data streams, from several devices and in large volumes, think hours and hours of heart rate readings for example. All this data must be anonymised, since you’re not allowed to store any personal data when conducting your trial.”

Therefore strong data management is crucial for a successful eHealth trial. Leonie: “While endless detailed data is amazing for detecting trends, it means data management has to be organised perfectly; to guide the different data streams and link them properly (and anonymously), to process its volume and ultimately to perform statistical analyses.”

Adding value as CRO

When a clinical study proves efficiency or sustainability of novel digital tools that improve care for patients, then that’s wonderful.

As a research organisation, we aim to contribute to accessible and affordable healthcare.

Leonie adds: “As CRO, we want to play our part and advance developments by demonstrating the added value of eHealth. How great is it nowadays, that you can easily and quickly track your health on your smartphone or watch? And when a clinical study proves efficiency or sustainability of such novel digital tools, which can improve care for the patients, then that’s wonderful.”