Scientists at the Scripps Research Digital Trials Center have partnered with the health technology company CareEvolution to launch a remote study that will investigate whether wrist-worn devices, such as activity trackers and smartwatches, can help people with long COVID manage and reduce the severity of their symptoms.
New treatments and interventions are urgently needed. We're excited to launch the Long COVID Wearable Study and apply our team's expertise in sensor technologies and digital trials to collecting robust data on how activity trackers might provide some patients with much needed relief. While symptom management will not remove the root cause of long COVID, we hope to validate the patient community's experience that pacing is currently one of the best ways to reduce symptom severity, and wearable devices can help implement pacing."
Julia Moore Vogel, PhD, study principal investigator
Even as COVID-19 precautions end, long COVID continues to exact a heavy toll on millions of people worldwide. An estimated 65 million individuals have long COVID and there are currently no broadly effective treatments. The illness consists of a collection of symptoms that develop and continue after a COVID-19 infection. It can affect multiple organ systems of the body including respiratory, cardiovascular, neurological, musculoskeletal and immunological, with symptoms varying from person to person. For many, long COVID has a profound and debilitating impact on daily life.
Researchers have observed significant overlap between long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), with many patients struggling with post-exertional malaise-;a worsening of symptoms after even minor physical, mental or emotional exertion. Many also suffer from Postural Orthostatic Tachycardia Syndrome (POTS)-;an increase in heart rate when a person stands up or walks, causing dizziness and heart palpitations. For both conditions, patients have reported that monitoring levels of energy expenditure has helped them improve symptom management. This exercise, known as pacing, allows patients to identify their own quantitative thresholds to help avoid symptom exacerbation.
Trackers that collect a range of metrics-;including heart rate, heart rate variability, physical activity, sleep patterns and stress levels-;have been shown to be helpful tools for capturing and monitoring a person's physiological state throughout the day. The Long COVID Wearable Study will allow scientists to analyze sensor data from participants coupled with data related to diagnoses, symptoms and quality of life collected via surveys. The goal of the study is to determine if long COVID, ME/CFS, and POTS patients who wear wrist-worn activity trackers and who receive educational materials on pacing see a decrease in symptom severity and whether this differs by device brand.
To conduct the trial, Vogel and colleagues partnered with CareEvolution, the company behind the MyDataHelps digital clinical trial platform. Participants can enroll, complete electronic consent, answer surveys and communicate with study coordinators via a mobile or web app, making it possible for people to participate remotely, without the need to visit a clinic.
"The ubiquity of smartphones is driving a new era in research where traditional barriers for participation are being removed," says Vik Kheterpal, MD, principal at CareEvolution. "The long COVID community is a perfect example of a patient group that can benefit from a digital trial experience, which enables participation from home, at your own pace."
While participants can use their own activity tracker or smartwatch to take part, the study team will also be distributing 500 Garmin wearables to an eligible subset of participants who do not own a device.
For more details about the Long COVID Wearable Study including how to participate, visit longcovid.scripps.edu.
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