As doctors and researchers have continued to learn more about COVID-19, they have also been learning about the effect of preexisting conditions and the risk for serious COVID. This data may be able to help determine who is most at risk for serious COVID-related complications.

Some researchers, however, have noted that much of the available information is anecdotal and COVID-19 severity is related to more than just preexisting conditions. A recent study conducted by researchers at Purdue University and the UAE College of Information Technology analyzed data from 54 published studies on COVID-19 and its effects on other conditions.

Preexisting Conditions & COVID-19

Among the 54 articles evaluated by researchers, cancer, kidney disease, and stroke were the most common complications listed as caused by COVID-19. Diabetes, hypertension, and cholesterol levels were commonly listed as being associated with more severe COVID-19 cases.

As with most illnesses, however, those with preexisting conditions are more likely to have complications than those without. Preexisting conditions can change how a person’s body works, making it harder to discover the impact of a virus like COVID-19.

Further, preexisting conditions may be caused by unhealthy environmental factors or lifestyle choices. These factors may still be present in patients who have had COVID-related complications and may be related to the severity of COVID as well.

Does General Health Correlate with COVID-19 Severity?

Researchers note that associating cancer, kidney disease, and stroke with COVID-19 should be carefully interpreted. This is not only due to the sample size in the studies, but also because patients could have other risk factors that affect illness in general.

Age, a history of smoking, or other clinical conditions suggests that other factors might be associated with poor COVID-19 outcomes rather than apparent comorbid conditions. Further research regarding this relationship and its clinical management is needed for a definitive conclusion.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.

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During this COVID-19 pandemic, many individuals have found themselves in a unique situation of having to work remotely. While this may seem like a positive change, some may start experiencing difficulties in staying productive while working remotely. Having recently been in this situation myself, I would like to share five tips that have helped me stay focused and productive while working from home.

How to Stay Productive at Home

1. Find a Workspace

2. If you are used to physically commuting to work every day, then working remotely will be quite the change for you. Previously, there was physical separation between work and home – your goal should be to recreate that as much as possible while working remotely in order to maximize your productivity. This can mean a variety of different things, but the basic idea is to have a separate area of your house which is dedicated to working. If you are fortunate enough to have a home office, then that would work perfectly. But, if you don’t, it is not a big issue as this workspace can be anything from a corner of your bedroom to an empty den in the basement. The important part is that you have a small space dedicated to work and work only

4. Keep a Tidy Desk

5. Studies have shown that a clean desk can have positive effects such as reducing stress and improving motivation but for the purposes of this article we will look at a study published in the Journal of Consumer Research regarding the effects of a clean workspace and focus. In this study, 103 subjects were instructed to sit in a clean workspace or an untidy room. The subjects were then moved to a separate room and asked to work on a geometry puzzle. The results of this study showed that those who spent time in the clean workspace spent 1,117 seconds on the task whereas those in the untidy room only spend 669 seconds. In summary, people were able to focus for a longer period of time when they were in a clean workspace. With a cluttered workspace, there are many distractions around and it is easy to lose focus from the task at hand. Having a tidy desk eliminates these distractions and makes it easier to stay focused.

7. Make sure you have the necessary technology

8. Technology is what affords us the ability to work remotely, so make sure to take home a laptop, charger, keyboard, mouse, and anything else you may need. Personally, I absolutely love using an external monitor at home because it allows for more screen real estate and increases my productivity. The most important part about working remotely would be the required software. Make sure to review company policies or talk to your manager and figure out what software needs to be downloaded on your computer to allow remote work. Most companies are utilizing software such as Skype, Zoom, Hangouts, GoToMeeting, Slack, etc… Keep in mind that some applications and files may not be accessible from your home WiFi network or require a special security key to log in. It is recommended to liaison with your company’s IT department to ensure you have all the tools necessary to work remotely.

10. Get Dressed

11. While this may seem like a small tip, it has massive psychological impacts. When I first started working remotely, I would stay in my pajamas as long as I could. I realized that this actually made me less productive. Changing clothes in the morning works like a “mental trigger” which allows your brain to distinguish between work and home. This includes carrying on your regular routine such as brushing your teeth, showering, makeup if that is something you normally do. Not only will you be taking care of yourself, but it will start putting you in the right mindset to get work done. Not to mention that even though you are working remotely, there will be an abundance of video meetings that you will need to look presentable for.

13. Embrace the Camera

14. While getting in front of the camera may make you feel uncomfortable at first, it is crucial for building social connections with your coworkers especially when most of your team members are working remotely. Additionally, being on camera gives certain advantages versus only being available through the microphone. For example, having the webcam on allows you to understand facial expressions which can play an important role in communication.

Overall, I know that working remotely is a new concept for many employees, and hope these tips can help you stay more productive throughout these unprecedented times. Stay healthy and safe!

Biofortis is a full-service contract research organization, specifically focused on clinical trials in the areas of foods, ingredients, and dietary supplements. With the outbreak of COVID-19, subject and staff safety has been our top priority. Some studies are still running at our site while others have been put on hold. Please see our website www.biofortisresearch.com for a summary of our COVID-19 safety response plan.

About the Author

Furhan Yacub has been with Biofortis Clinical Research since 2016 in various roles and began working as a Clinical Research Coordinator in 2019. Since then, he has managed a variety of nutritional, gastrointestinal, and pharmaceutical clinical trials. Furhan graduated from the University of Illinois at Chicago in 2018 with a degree in Neuroscience. During his free time, he likes to play video games with friends online or play basketball at the gym.

References:

Chae, Bououn, and Rui Zhu. “Environmental Disorders Leads to Self Regulatory Failures.” Journal of Consumer Research, 19 Dec. 2013, www.jstor.org/stable/10.1086/674547?origin=JSTOR-pdf&seq=1.

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Biofortis Clinical Research site in Addison remains open for both clinical visits and consumer testing.

As the COVID-19 situation continues to evolve, Biofortis and its parent company, Mérieux NutriSciences, are taking action both for the safety of our employees and to help protect our subjects and our larger community.

Our priority is to create as low risk an environment as possible for our staff and for our subjects in order to help minimize the potential spread of the virus.

Biofortis Clinical Guidelines for COVID-19

In accordance with federal and state recommendations.

All People Entering the Building

• Must complete a brief health questionnaire upon entrance and those recording relevant risk factors are refused admittance
• Will have gloves, masks, hand washing stations, tissues, and sanitizer available to them
• Are requested to cough and sneeze into their elbow or a tissue and immediately wash hands after and sanitize
• Are encouraged to avoid touching their face as much as possible
• Must not enter the building if feeling ill but call to reschedule the appointment

Cleaning and Infection Control Measures

• Areas utilized by staff and/or subjects are frequently sanitized after use on all surfaces including, but not limited to, chairs, tables, keyboards, pens, etc. . .
• A cleaning and sanitizing schedule is implemented daily
• Sanitation solution is available for all employees throughout the building for sanitation use
• Maintain the practice of good hygiene by all staff including frequent hand washing
• Staff must wear face coverings
• Social distancing will be maintained whenever possible

Ongoing Clinic Study Visits

• In-person visits are modified to limit contact as much as possible and vary based on study requirements
• Curbside pickup when able will be utilized for product dispensation
• Study materials are sanitized in between each use during visits

Sensory Testing

• When able, descriptive and consumer studies have moved to curbside pickup with samples being placed directly in the panelist trunk.
• In lab testing parameters have been implicated:
  • Extra 5 minutes in between sessions to thoroughly clean the booth area in between sessions, which includes the computers, mice, keyboards, walls, chairs, etc.
  • Limit the number of consumers per session to every other booth testing.
  • Even before the pandemic, our sensory staff was trained to handle and serve food safely. This includes but not limited to: wearing gloves and changing them as often as needed, cleaning and sanitizing all work surfaces, and avoid being in the kitchen when ill.

As the situation rapidly evolves, our Global MXNS task force continues to monitor the situation and provide updated guidance and, if necessary, updated restrictions. Biofortis will implement the updated restrictions immediately.

Please feel to reach out to us with any additional questions you may have.

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• New methods to collect clinical trial data, especially in view of the COVID-19 pandemic, should be considered
• Faster and potentially more accurate data collection
• Benefits and limitations of mobile app technology in clinical trials

The potential for mobile technology in improving clinical trials is being increasingly recognized by sponsors and researchers.  For several years, the Food & Drug Administration (FDA) has been encouraging the use of mobile technologies to enable faster, more cost-effective clinical trials (1). With the concerns of the safety of in-person clinical visits during the COVID-19 pandemic, mobile platforms for remote data collection as well as remote data audits might be a solution for clinical trials now and in the future.

Benefits of Utilizing Mobile Apps in Clinical Research

Enhanced Safety

Top of mind now is the safety of study subjects and staff. On March 18, FDA just released its guidance (2) on the safety of conducting clinical trials during this pandemic. If it is not possible for the study subjects, staff, or monitors to be safely present at the research facility, alternative methods for study visits, such as virtual study visits, may be a solution.  Virtual visits (both for the study subjects as well as the monitors) will include electronic tools to capture data. Overall, the FDA is granting clinical research sites flexibility to consider remote visits and electronic data capture to ensure the safety of all involved.

Improved accuracy

Data collection in real-time reduces errors and improves efficiency because the information is transferred directly from the subject in real-time to an electronic data capturing (EDC) system. These include responses collected using wearables such as Apple Watch, Android Watch, FitBit, and other activity or diet trackers, or patient-reported outcomes from customized surveys.  The EDC can also be programmed to detect errors and prompt the participant to correct the error before moving forward.  Researchers can also monitor the results in real-time, thus allowing for timely corrective actions.

Real life in real time

App-based clinical studies can take advantage of the latest in mobile technology to collect real-world data in real-time, such as on physical activity, heart rate, sleeping patterns, food intake, and social interactions without the confounding factors introduced by an artificial clinical trial setting. Mobile apps may also be configured to send out customized notifications for any event or response entered in a study – an especially helpful feature for rapid visibility on adverse events. This indirectly makes a study safer for participants and allows for better outcomes.

Borderless E-studies

Mobile technology not only revolutionizes the way data is collected and monitored but allows for more expansive studies with less subject burden.  Omnipresent mobile apps enable larger, multi-site studies with unlimited geographic boundaries and subject diversity. Indeed, since 2014, the number of active mobile devices has outnumbered the world population (3). Virtual, app-based recruitment, test visits, and follow-up appointments reduce the need for physical site visits and saving time for both researchers and participants.  More than 75% of US adults surveyed expressed a preference for joining a mobile trial compared to only 7% for a traditional trial (4), suggesting the potential for faster recruitment and better retention in trials utilizing mobile technologies.

The Future of Mobile Technology and Clinical Research

Mobile technology has the potential to make clinical trial participation more safe and convenient for participants as well as help researchers improve operational performance and potentially reduce the risk of clinical trial deficiencies.  However, the implementation of mobile apps in clinical research requires an understanding of its potential limitations and challenges.  These include concerns on data security and resistance from participants such as those with limited experience with technology (e.g., the elderly).  Despite the benefits of mobile apps, some trials are better conducted in a traditional, non-mobile-based setting.  Thus, companies interested in using mobile apps in clinical trials are urged to seek out experienced research organizations to ensure the successful implementation of mobile technologies in their trials.

As a leading contract research organization, Biofortis Research, a division of Mérieux NutriSciences, has been successfully utilizing mobile technology in clinical trials.  Biofortis offers full clinical trial services from protocol design, recruitment, trial executive, data collection, and analysis to writing reports and publications to assist customers who are interested in conducting clinical trials with or without mobile technology.

References:

(1) FDA. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-launches-new-digital-tool-help-capture-real-world-data-patients-help-inform-regulatory-0

(2) FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

(3) Independent. https://www.independent.co.uk/life-style/gadgets-and-tech/news/there-are-officially-more-mobile-devices-than-people-in-the-world-9780518.html

(4) Perry B, Geoghegan C, Lin L, McGuire FH, Nido V, Grabert B, Morin SL, Hallinan ZP, Corneli A. Patient preferences for using mobile technologies in clinical trials. Contemp Clin Trials Commun. 2019;15:100399.

Author Bios

Valerie Wass, RDN, LDN

Val has worked for Biofortis Research in Addison, IL for 10 months as a Clinical Research Coordinator and she is also a Registered Dietitian. Prior to Biofortis Research, Val worked as a registered dietitian focusing on weight loss nutrition counseling and as a corporate dietitian for a food service management company. In her spare time, Val enjoys cooking, walking her black Labrador, and hiking in the mountains.

Claire Dillon, RD, LDN

Claire has been with Merieux NutriSciences for 2 years in various roles and now is a Clinical Research Coordinator with Biofortis Clinical Research. Claire is a Registered Dietitian with experience in clinical and long-term care settings. In her free time, she enjoys relaxing with her cats and trying out the newest restaurant in town with her friends.

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