Wearable Devices Enable Long COVID Patients to Decrease Symptom Severity: A Case Series From Pilot User Testing

Supplemental Digital Content is Available in the Text.

Abstract

Purpose:

Long COVID is a debilitating condition that is estimated to affect over 65M individuals across the world after a Coronavirus Disease 2019 (COVID-19) infection and has no broadly effective treatments. People with Long COVID have reported that pacing helps manage their symptoms, but it is difficult to implement. Based on experiences in the Long COVID community, we hypothesized that wearable devices can help individuals pace and reduce their Long COVID symptom severity.

Methods:

To inform the design of a larger study, we performed user testing by distributing Garmin® devices, the study surveys and pacing educational materials to 11 individuals with Long COVID, and conducting interviews to learn about their experience.

Results:

Eight of the 9 (89%) individuals reported that the information provided was helpful for their symptom management, and 2 testers did not complete the final survey. Four (44%) users had not used a wearable device before and none had trouble setting up their device. Due to the limited sample size and lack of control group, generalizability is unknown.

Conclusions:

The most user testers reported that the study materials were helpful for their symptom management. These results are a promising indication of the potential for wearable devices and educational materials to help individuals with Long COVID, and potentially other chronic conditions such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), decrease symptom severity.

Clinical Pearls

• •Pacing, the careful management of exertion, is used to manage conditions such as ME/CFS; however, it is difficult to implement.

• •Early data from user testing to inform a larger study is consistent with the patient community's reported benefit of using wrist-worn wearables to support people with Long COVID in implementing pacing.

• •By providing personalized, real-time data, wrist-worn wearables can help people with Long COVID identify and prioritize exertion based on their personal disease presentation and lifestyle.

INTRODUCTION

Over 65M individuals across the world suffer from Long COVID,¹ a debilitating constellation of symptoms that, by definition, persists more than 28 days after a Coronavirus Disease 2019 (COVID-19) infection.² The set of symptoms among affected individuals is diverse. Over 200 symptoms have been documented; they vary in intensity (in 1 study 25% of patients unable to return to work) and vary in duration (with over 70% of patients experiencing symptoms 7 months after their initial infection).² Research has demonstrated that symptoms last for years.^3-5 Symptoms often follow a recovery and relapse pattern, with common relapse triggers being physical, mental, and emotional exertion.⁶ There are currently no broadly effective treatments.

Pacing, the careful management of exertion, is 1 effective way to manage one of the most common Long COVID challenges - postexertional malaise (PEM), also called postexertional neuroimmune exhaustion and postexertional symptom exacerbation.^7,8 PEM is also a key feature of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition with significant overlap with Long COVID. Postexertional malaise is the worsening of symptoms that would otherwise be tolerated. Worsening symptoms can include physical fatigue, cognitive difficulties, sleep issues, and loss of stamina. Postexertional malaise can occur immediately or a few days after exertion.^2,9 The Center for Disease Control and Prevention's (CDC's) 2021 guidelines on Long COVID referenced pacing, as an effective method for managing symptoms,^10,11 and 1 study looked at 3762 Long COVID patients and found that pacing and energy monitoring were the treatments that patients found the most helpful in working toward resolving symptoms and/or avoiding peaks and valleys in day-to-day functioning.² Pacing was reported as slightly or significantly helpful by 42% of patients and was the most helpful treatment option.² This aligns with evidence that pacing has been helpful for managing a number of other chronic conditions, most notably Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).^12-14

A 2022 study surveyed 488 individuals with ME/CFS to obtain their attitudes and experiences with heart rate monitoring, a feature available on most wearable devices. The survey identified that over 100 devices were used for monitoring with the most popular being the Apple Watch, followed by Garmin®. The findings showed that 72% said their monitor helped them better understand their PEM triggers and 31% said it improved their ability to complete self-care.¹⁵ In addition, wearables can be used to assess ME/CFS severity.¹⁶ Since Postural Orthostatic Tachycardia Syndrome is defined by changes in heart rate,¹⁷ self-monitoring of heart rate can help individuals understand the condition and identify flares.

It has recently been demonstrated that infections including COVID-19 are associated with physiological changes that can be detected by wearable devices.^18-22 In particular, metrics derived from heart rhythm (e.g. resting heart rate and heart rate variability) may serve as markers of COVID-19 infection and are already measured by numerous wearable devices.^23,24 In the digitizing real-time COVID-19 tracking (DETECT) study, wearable device data from 875 participants where 234 were COVID-19 positive and 641 COVID-19 negative were used to track metrics when healthy, during an infection, and time to return to baseline.²⁵ DETECT findings suggested that COVID 19 cases may be more accurately detected by combining wearable data with self-reported symptoms compared to symptoms alone and may help track the status of a patient well after the acute phase of COVID-19 has passed.^22,26 The ability to monitor energy expenditures in real-time can allow individuals to identify their own quantitative thresholds to avoid PEM and improve symptom management. The Warrior Watch Study, conducted by the Mount Sinai Health System, measured changes in participants' heart rate variability that were directly correlated with a COVID-19 infection, and highlighted the use of wearables as an effective way to address health needs and improve management of the disease.²⁷ Beyond COVID-19, heart rate variability has been implicated in a variety of medical conditions and recovery after exertion.²⁸

By combining previous research findings and the patient experiences described within the Body Politic COVID-19 community, we designed a study, called the Long COVID Wearable Study,²⁹ to evaluate whether wrist-worn wearables and educational materials could help patients pace and reduce Long COVID symptom severity. Here we describe the result of user testing that was done as part of the study design process. We plan to follow this with a randomized control trial with 1000 participants.

METHODS

Ethical Considerations

The Scripps Institutional Review Board reviewed the pilot study, and it determined that it was exempt from full review given that identifiable data were not being collected.

User Tester Recruitment

We recruited 11 individuals living with Long COVID from various Long COVID support groups, with assistance from colleagues at the Patient-Led Research Collaborative. We made an effort to recruit a diverse group of testers; among these participants, 8 (73%) self-identified as belonging to racial and/or ethnic groups historically underrepresented in biomedical research and 1 self-identified as transgender (Fig. 1).

Fig. 1.

Examples of Body Battery™ levels and accompanying comments in the Garmin® app.

Study Design

Participants in the full study will be enrolled for 12 months, but user testers were asked to participate for only 1 month to obtain feedback on all study materials. While the testing period mirrored the planned study design for the full study, the primary focus was to assess if the design and materials provided required any adjustments, and if the testers could confirm some benefit from the wearable device, even in the condensed time frame. After the testers were selected, they were asked to choose one of the following 3 Garmin® devices: vívosmart®4, Venu®, or the Forerunner® all which featured the Body Battery™ (Fig. 1) function. The Garmin® devices were selected after a comprehensive comparison and review across several device brands (see Appendix, Supplemental Digital Content 1, http://links.lww.com/CPTJ/A36).

Devices were provided at no cost to the tester and came with manufacturer instructions and recommendations on how to set it up. In addition, educational materials that had been developed for the full study on symptom mitigation and general guidelines to use the device to help with pacing were also provided. Testers were also provided with a guide that provided the complete set of study surveys for the full study along with additional feedback surveys specific to the user testing. The full study surveys included clinically validated surveys on symptom frequency and severity (Abbreviated DePaul Symptom Survey),³⁰ overall quality of life (EQ-5D-5L).^31,32 Both surveys have been widely used in clinical research,^33,34 and with the lack of validated surveys specific to Long COVID symptoms, we selected the DePaul Symptom survey, which assesses common symptoms of ME/CFS which most people with Long COVID have.^7,35 In addition, study-generated surveys on relapse, the user-tester preferred term for PEM, frequency were designed to collect specifics on the timing, duration, and severity of relapses. We decided to use patient-reported perceptions of symptom severity and perceptions of whether the device was helpful, consistent with use of patient-reported outcomes in the field^36,37 given a lack of biomarkers available to diagnose and manage Long COVID.³⁸ All study surveys are available for review in (see Appendix, Supplemental Digital Content 1, http://links.lww.com/CPTJ/A36).

Procedure

During the 2-week testing period, participants wore the Garmin® device and completed the study surveys at the requested times per the guide. For the purposes of this user testing, we did not evaluate the study survey responses, because each survey was completed once and a change could not be analyzed; instead, we examined whether surveys were completed. Further, user testers were not asked to share their wearable device data as these data would not be analyzed. At the end of their testing period, testers provided feedback through 2 written feedback surveys and a one-on-one qualitative interview (see Appendix, Supplemental Digital Content 1, http://links.lww.com/CPTJ/A36). The feedback surveys were focused on evaluating their overall experience with the device, the time commitment required to complete the study surveys, and the educational materials. Specifically, we wanted to determine if the testers had previous experience using a device, and whether they found the device and educational materials user friendly. For those testers that experienced a symptom relapse during the testing period, we collected information on if they felt that the device and education reduced the overall severity and duration. The qualitative interview questions were selected to have the testers elaborate on what areas of the study design they felt could be improved, if the device added value to their symptom management, and if any information should be added or removed. In addition, we investigated whether users who did not purchase devices for themselves, which could be due to affordability, awareness of the potential to use them for symptom management, or other reasons, would benefit from their use.

RESULTS

As noted above, the results of the symptom, quality of life, and relapse surveys were not analyzed, but only marked off for completion. With the condensed testing timeline, we had a focus on examining if the testers felt that the time required for study tasks would be reasonable for someone with Long COVID versus the responses themselves. The results of the feedback survey were analyzed, and Table 1 shows that 8 of the 9 (89%) individuals who completed the surveys reported that the information provided was helpful for their symptom management. Two individuals did not complete the final survey and were considered lost to follow-up. Of the 7 (77%) who experienced a worsening of symptoms, during the user testing time period, 6 (86%) stated that the study information and device helped reduce the severity or duration of their relapse. Of note, 4 (44%) users had not used a wearable device before and none had trouble setting up their device. All users found the devices study materials easy to understand.

TABLE 1.

Symptom Management Data

Question	Yes	No	N/A or Incomplete
Have you ever used a wearable device before?	6	4	1
Did you find the information provided helpful for your symptom management?	8	1	2
Were the study materials provided easy to understand?	9	0	2
During the testing period, did you suffer a relapse?	7	2	2
If you suffered a relapse, did the device and education help reduce the severity or duration?	6	1	4

After the completion of the interviews, the responses were reviewed to identify any common themes regarding the design, study materials, and benefit from the wearable device. Testers were also given an opportunity to provide quotes on their experience. The quotes selected for use support the theory that even in a short time frame such as this user testing period, wearable device users can derive significant benefit. Quotes from the qualitative interviews include “With this information I have made adjustments and accommodations in my lifestyle, empowering me to care for myself in a more proactive way.”; “I found energy levels fall below zero often during the day and in the past I would have ignored them. The wearable study allowed me to combat the fatigue by triggering rest sessions that increase energy.”; and “My participation, as a user tester in the Covid study, has greatly helped in managing the fatigue, along with many other things…The body battery section alone, of the Garmin app, takes the guesswork out of knowing when to take a break, pace yourself, or even take a day off.”

Lived Experience Perspective

Below are quotes from user testers regarding the study materials.

1. “Through this wearables study…I have made adjustments and accommodations in my lifestyle, empowering me to care for myself in a more proactive way.”

2. “My participation…has greatly helped in managing the fatigue, along with many other things.”

3. “I never fully recovered (March 2020) from Covid, the Long COVID Wearable Study has by far been the most helpful. I've done so much research on my own, before the study, that my doctor said I could run my own clinic.”

4. “I long thought I dodged heart-related issues as I never developed characteristic symptoms in 2020 to 2022. I also didn't connect recent heart rate changes to other long-term symptoms I've had since 2020. However, thanks to the wearable, I'm connecting the dots and getting additional medical care in month 35 of my long haul for a cluster of symptoms that I didn't associate with cardiology.”

DISCUSSION

The large majority of user testers reported that the study was helpful for their symptom management. Surprisingly, double the proportion of individuals reported that the study was helpful for symptom management compared with Long COVID patients who otherwise tried pacing, as studied independent of this effort.³ The benefit for these individuals was large, particularly relative to the low risk nature of the study. In addition, all 11 user testers were sent a follow-up 12 months after completing their participation to determine if the device was still being used. We received responses from 7 of the testers (67%), and all stated that they still consistently use their wearable device and continue to derive benefits related to their symptom and overall health management.

Due to the small sample size and lack of control group, a well-powered, well-controlled and longer duration study needs to be conducted to establish statistical significance and study the durability of these effects. We are collecting data for a randomized control trial that launched in March 2024 and the study-provided wearable arm fully accrued in August 2024.

Given the lack of effective Long COVID treatments, these results are a promising indication of the potential for wearable devices and educational materials to help individuals with Long COVID, and potentially other chronic conditions such as ME/CFS, decrease symptom severity.