LONDON, Jan. 13, 2023 Huma Therapeutics Limited (“Huma”), a leading global digital health company, today announced results of a new study in collaboration with the Medical Research Council Epidemiology Unit at the University of Cambridge showing that participants using Huma’s clinical trial platform had high, sustained levels of engagement in an observational, fully remote COVID-19 study.
The study, published in the Journal of Medical Internet Research1, involved 62.61% (2524/4031) participants from the longitudinal Fenland study, making it the largest population-based study to-date exploring how digital technologies can support population research.
From the participants, 90.21% (2277/2524) completed the app-based onboarding process and signed e-consent. In addition to using the study app (available for both iPhone and Android), each was also sent a digital pulse oximeter (to measure blood oxygen levels) and thermometer. They were provided with remote set-up assistance and were asked to record the following biomarkers:
- blood oxygen saturation (three times per week)
- body temperature (three times per week)
- resting heart rate (three times per week)
- activity levels (measured passively)
- respond to monthly questionnaires
- blood spot samples to test for the presence of coronavirus antibodies.
Participants had a positive experience with the study app, finding it easy to use and quick to report measurements and symptoms. They took part in the observational study for at least 6 months and most kept completing measures until asked to stop; there was minimum drop off in engagement over the study period. On average, people used the study app for 34.5 weeks (7.9 months), with only 2.5% of participants withdrawing from the study. It was interesting to see a higher engagement rate amongst the participants aged over 65.
Dr Arrash Yassaee, Global Clinical Director at Huma, said: “Huma is committed to building robust clinical and scientific evidence for its technology. The high level of engagement and retention we’ve seen in this study is very encouraging. User-friendly clinical trial technologies such as Huma’s have great potential to transform population-based health research by increasing access and reducing the burden on participants. This kind of data collection is incredibly valuable for understanding health and disease processes in the real world and gathering insights that can make a difference to people’s lives.”
Dr Kirsten Rennie, a Senior Research Associate at MRC Epidemiology Unit and an expert in quantitative measures of physical activity and diet, who led the study said: “Enrolment and retention in traditional cohort-based observational studies is a constant challenge and participation has been declining in recent years. Here we saw not only great enrolment and retention, but also engagement which has helped us create a useful checklist for other researchers to follow.”
The COVID-19 pandemic accelerated interest in the use of digital health solutions for remote health monitoring. But while these technologies have shown benefits for patients with chronic or acute health conditions, less is known about their utility in population-based health research, where it is becoming increasingly hard to recruit participants and keep them engaged over months or even years.2
- Rennie KL, Lawlor ER, Yassaee A, Booth A, Westgate K, Sharp SJ, Tyrrell CS, Aral M, Wareham NJ. J Med Internet Res. 2022 Oct 3. doi: 10.2196/40602. Epub ahead of print. PMID: 36194866.
- Morton LM, Cahill J, Hartge P. Reporting Participation in Epidemiologic Studies: A Survey of Practice. Am J Epidemiol. 2006;163(3):197-203. doi:10.1093/AJE/KWJ036
Huma Therapeutics is a global digital health technology company that advances digital-first care delivery and research to help people live longer, fuller lives.
Huma’s award-winning modular platforms are used by more than 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 650,000+ participants across research. Huma’s regulated Software as a Medical Device powers:
- remote patient monitoring (RPM) for health systems
- companion apps to support patients through treatment and drug therapies
- virtual clinical trials to accelerate research
Huma’s Decentralized and Hybrid Clinical Trial (DCT) platform now includes the clinical expertise of Alcedis GmbH, a global digital first clinical trials company and market-leader for data driven clinical research and technology.
About the Medical Research Council Epidemiology Unit
The MRC Epidemiology Unit is a department at the University of Cambridge. It is working to improve the health of people in the UK and around the world. Obesity, type 2 diabetes and related metabolic disorders present a major and growing global public health challenge. These disorders result from a complex interplay between genetic, developmental, behavioural and environmental factors that operate throughout life. The mission of the Unit is to investigate the individual and combined effects of these factors and to develop and evaluate strategies to prevent these diseases and their consequences. www.mrc-epid.cam.ac.uk
Chief Corporate Affairs and Marketing Officer, Huma
Karen Birmingham PhD
Head of PR & Communications, Huma
Journal of Medical Internet Research
Method of Research
Subject of Research
Engagement With mHealth COVID-19 Digital Biomarker Measurements in a Longitudinal Cohort Study: Mixed Methods Evaluation
Article Publication Date
Huma Therapeutics Ltd developed, validated, and tested the app at no charge. AY, MA, and AB are employees of Huma Therapeutics Ltd.