January 18 2024, 10:00 GMT
In a ground-breaking effort to enhance the patient-centricity of clinical trials, Aparito has collaborated with the University of Cambridge Royal Papworth Hospital, Pulmonary Hypertension Association UK, and Garmin Health to redefine the parameters of measurement and engagement in clinical research to develop the Digital 1-Minute Walk Test (d1MWT).
Traditionally, the 6-Minute Walk Test (6MWT) has been a cornerstone in assessing patient function and prognosis. However, Dr. Joe Newman from Royal Papworth Hospital challenged the status quo by questioning the arbitrary nature of the 6MWT duration (Butland et al. 1982). The research suggests that the 6-Minute Walk Distance (6MWD) may be shortened, offering numerous advantages for both patients and research protocols.
The first study involved 102 patients with Pulmonary Hypertension (PH) and 91 patients with Interstitial Lung Disease (ILD) and demonstrated that the distance walked in the 1st minute (1MWD) correlates nearly perfectly with the traditional 6MWT distance.
Furthermore, 1MWD and 6MWD show equivalent correlations with quality-of-life measures and predictive abilities for 3-year mortality.
The study team then used Aparito’s Atom5™ platform to gather raw data from patients with pulmonary hypertension using Garmin wearables via Garmin Health’s SDK integration to capture outdoor 1-Minute Walk Tests (1MWTs).
This technically accurate, safe, and repeatable system strongly correlates with the gold-standard 6MWT.
Patient-Centric Digital Innovation
Digital innovation plays a pivotal role in this paradigm shift: the introduction of the digital 1MWT facilitates decentralised (remote) trial delivery and reduces patients’ travel time and costs. It allows for higher frequency of testing, captures other wearable data (such as step count), and integrates seamlessly with digital Quality of Life measures (ePROMs).
“Why bother shaving off 5 minutes?” asks Dr. Newman. “The advantages are numerous; increased comfort for patients, higher adherence, greater inclusivity for those who can’t walk for 6 minutes, significant time and cost savings for physiology departments, and enhanced practicality in outdoor settings.”
Dr Newman’s research emphasises the importance of patients’ perspectives. Through extensive collaboration and feedback, it was found that patients prefer remote digital testing and shorter walk times.
This insight has led to a new digital biomarker – the d1MWT – with both technical accuracy and high patient acceptability.
Dr. Newman poses a critical question: “Could the d1MWT provide a decentralised and patient-centred solution to the need to innovate endpoints in trials of heart/lung disease and clinical practice?”
Whilst this study is undoubtedly a promising step forward for patients with pulmonary hypertension, it has the potential to help many other patients beyond this rare lung disease.
To read the paper in full please visit The Digital 1-Minute Walk Test: A New Patient-centered Cardiorespiratory Endpoint | American Journal of Respiratory and Critical Care Medicine | Articles in Press (paywall)
Aparito’s mission is to digitise clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments.
Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to digitise clinical trials using novel eCOA and generate continuous real-world data.
Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies.