Source: Huma Therapeutics Ltd
Copyright: The Authors
URL: https://www.jmir.org/2023/1/e4060
License: Creative Commons Attribution (CC-BY)
- More than 90% of 2524 participants invited to join a fully remote COVID-19 study, conducted by Cambridge researchers, downloaded and registered on the study app [1].
- Approximately 75% of participants completed digital biomarker assessments such as resting heart rate, temperature, and oxygen saturation at least once per week [1].
- Participants were aged 45-70 years and took part for an average of 8 months [1].
LONDON, January 13, 2023. Today, Huma Therapeutics Limited (“Huma”), a leading global digital health company, announced the results of a new study in collaboration with the Medical Research Council Epidemiology Unit at the University of Cambridge, showing that participants who used 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 Research [1], involved 62.61% (2524/4031) of the participants from the longitudinal Fenland COVID-19 study, making it the largest population-based study to date, exploring how digital technologies can support population research.
Overall, 90.21% (2277/2524) of participants completed the app-based onboarding process and signed e–consent forms. In addition to using the study app (available for both iOS and Android devices), each participant was also sent a digital pulse oximeter (to measure blood oxygen levels) and a thermometer. They were provided with remote set up assistance and were asked to record the following biomarkers:
- blood oxygen saturation (3 times per week)
- body temperature (3 times per week)
- resting heart rate (3 times per week)
- activity levels (measured passively)
- responses 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 On average, people used the study app for 34.5 weeks (7.9 months), with only 2.5% of participants having withdrawn from the study. It was interesting to see a higher engagement rate among the participants aged over 65 years.
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 Arrash Yassaee, global clinical director at Huma]
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. [Dr Kirsten Rennie, senior research associate at the Medical Research Council Epidemiology Unit and an expert in quantitative measures of physical activity and diet, who led this study]
The COVID-19 pandemic accelerated interest in the use of digital health solutions for remote health monitoring. However, 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 difficult to recruit participants and keep them engaged over months or even years [2].
References:
- Rennie KL, Lawlor ER, Yassaee A, et al. Engagement with mHealth COVID-19 digital biomarker measurements in a longitudinal cohort study: a mixed methods evaluation. J Med Internet Res. 2022(3). doi: 10.2196/40602. PMID: 36194866. Epub ahead of print
- 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
About Huma Therapeutics
Huma Therapeutics (“Huma”) 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 3000 hospitals and clinics, with >1.8 million active users in health care and >650,000 participants across research studies. Huma’s regulated Software as a Medical Device powers the following:
- remote patient monitoring for health systems
- companion apps to support patients through treatment and drug therapies
- web-based clinical trials to accelerate research
Huma’s Decentralized and Hybrid Clinical Trial 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.
Please visit www.huma.com and follow Huma on LinkedIn.
About the Medical Research Council Epidemiology Unit
The Medical Research Council Epidemiology Unit is a department at the University of Cambridge. It is working to improve the health of people in the United Kingdom 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 among genetic, developmental, behavioral, 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. For more information, please visit www.mrc-epid.cam.ac.uk.
Media contacts
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karen.birmingham@huma.com
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