Wellinks announces IRB approved study

Jenny Barnett
July 12, 2021
Table of Contents

Wellinks, a leader in innovative respiratory technologies today announced the initiation of an IRB approved research pilot study for patients previously diagnosed with COPD.

The study, led by primary investigator Dr. Brian D. Gelbman, Associate Clinical Professor of Medicine at Weill Cornell Medical College and New York Presbyterian Hospital, will utilize a Bluetooth™ enabled version of Wellinks' Flyp Nebulizer and a suite of connected diagnostic tools including spirometry and pulse-oximetry. The devices communicate wirelessly with the Wellinks app on the user's phone. The data is then pushed to a HIPAA secure cloud environment to be displayed in dashboards and reports. The study aims to demonstrate the feasibility of collecting and tracking information essential to the management of patients with COPD including adherence to medication regimen, lung health, and symptoms onset among others. Investigators will also assess engagement and satisfaction with the Wellinks solution.

"Getting into the field with our first digital health offering and welcoming patients on the platform is an exciting milestone for us," says Wellinks President Geoff Matous. "The company is on a mission to reinvent respiratory care around the people who need it. The journey to improving outcomes and patient engagement in COPD includes generating objective data – this study is the first of many."

"The Flyp Nebulizer has always been popular with my patients with its cutting-edge design, said Dr. Gelbman. Now that Wellinks has made Flyp Nebulizer a smart device and developed the Wellinks software, I am eager to test the ability of this solution to offer comprehensive monitoring of COPD patients. Our hope is that with better home monitoring, we can detect exacerbations, understand medication compliance and usage, and adjust therapy to prevent clinical worsening. This could be immensely useful in the care of COPD patients, many of whom are homebound and have difficulty travelling to office visits, especially during the COVID-19 pandemic."

Chronic Obstructive Pulmonary Disease (COPD) is the name for a group of diseases that cause breathing problems. As many as 25 million Americans live with COPD, the nation's fourth leading cause of death and one of the costliest conditions. Wellinks research shows that despite greater than 80% of COPD sufferers would be open to digital health tools, only 10% use them today. The COVID-19 pandemic has had a significant impact on those living with COPD, including 71% reporting emotional stress.

Wellinks, a leader in innovative respiratory technologies today announced the initiation of an IRB approved research pilot study for patients previously diagnosed with COPD.

The study, led by primary investigator Dr. Brian D. Gelbman, Associate Clinical Professor of Medicine at Weill Cornell Medical College and New York Presbyterian Hospital, will utilize a Bluetooth™ enabled version of Wellinks' Flyp Nebulizer and a suite of connected diagnostic tools including spirometry and pulse-oximetry. The devices communicate wirelessly with the Wellinks app on the user's phone. The data is then pushed to a HIPAA secure cloud environment to be displayed in dashboards and reports. The study aims to demonstrate the feasibility of collecting and tracking information essential to the management of patients with COPD including adherence to medication regimen, lung health, and symptoms onset among others. Investigators will also assess engagement and satisfaction with the Wellinks solution.

"Getting into the field with our first digital health offering and welcoming patients on the platform is an exciting milestone for us," says Wellinks President Geoff Matous. "The company is on a mission to reinvent respiratory care around the people who need it. The journey to improving outcomes and patient engagement in COPD includes generating objective data – this study is the first of many."

"The Flyp Nebulizer has always been popular with my patients with its cutting-edge design, said Dr. Gelbman. Now that Wellinks has made Flyp Nebulizer a smart device and developed the Wellinks software, I am eager to test the ability of this solution to offer comprehensive monitoring of COPD patients. Our hope is that with better home monitoring, we can detect exacerbations, understand medication compliance and usage, and adjust therapy to prevent clinical worsening. This could be immensely useful in the care of COPD patients, many of whom are homebound and have difficulty travelling to office visits, especially during the COVID-19 pandemic."

Chronic Obstructive Pulmonary Disease (COPD) is the name for a group of diseases that cause breathing problems. As many as 25 million Americans live with COPD, the nation's fourth leading cause of death and one of the costliest conditions. Wellinks research shows that despite greater than 80% of COPD sufferers would be open to digital health tools, only 10% use them today. The COVID-19 pandemic has had a significant impact on those living with COPD, including 71% reporting emotional stress.

Driving Better Outcomes
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Wellinks is excited to announce the final results of ASPIRE – a clinical trial conducted with the COPD Foundation to assess the impact of Wellinks on quality of life, engagement and satisfaction among COPDF members living with COPD.

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Each participant received personalized health coaching, virtual pulmonary rehabilitation, and monitoring through connected devices and a patient-facing app.

The study enrolled 141 members in the trial, with 119 completing the 24-week study. These results demonstrate sustained engagement, satisfaction, and clinical response with Wellinks.

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Wellinks Engagement at 24 Weeks
(n = 141)

61%
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Enrollment Rate

Proportion successfully enrolled out of all who were interested and eligible

84%
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Retention Rate

Proportion who remained enrolled in the study at 24 weeks

These results were demonstrated in a population with...

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High Member Satisfaction at 24 Weeks

  • Over 81% said Wellinks helped them better manage their COPD
  • Over 92% found Wellinks to be valuable
  • Over 83% said Wellinks helped them learn more about their COPD
+64
Net Promoter Score*
* Net Promoter Score (NPS) is a customer loyalty and satisfaction measurement taken from asking customers how likely they are to recommend your product. NPS scores range from -100 to +100. This NPS is based on responses from those who continued contact with coaches, representative of the Wellinks clinical model.

Improved Clinical Outcomes at 24 Weeks

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Wellinks demonstrated sustained improvements in COPD self-efficacy as measured by the COPD Self-efficacy Scale (CSES) at 24 weeks.
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Self-efficacy is a measure of how confident an individual is in managing their COPD and addressing shortness of breath.
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One-third of participants demonstrated improvements in Modified Medical Research Council dyspnea score. mMRC is a measure of breathlessness that is associated with risk of future exacerbations.

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