Wellinks is investigating whether its chronic obstructive pulmonary disease (COPD) virtual management program — which offers health coaching, lung rehabilitation, and monitoring through connected devices and a mobile app — can reduce hospital readmission among people with COPD.
To test the platform, the healthcare company has teamed up with Hartford HealthCare to launch a clinical trial involving about 150 adults with COPD who have been hospitalized due to an exacerbation, or a sudden worsening of their symptoms.
The goal of the trial, called the “Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions” — POWER — is to determine if the online platform can cut the number of hospital readmissions needed for these patients.
“COPD is a complex medical condition that requires a multidisciplinary team approach. When patients are recovering from hospitalization, care gaps are difficult to close and can have a negative impact on outcomes,” Abi Sundaramoorthy, MD, chief medical officer at Wellinks, said in a press release.
“Wellinks is designed to bridge these gaps to engage and empower patients regardless of their access to traditional in-person resources. We are eager to work with Hartford HealthCare to advance the clinical evidence for virtual-first COPD care while helping more patients live fully and breathe freely,” added Sundaramoorthy.
COPD patients may experience acute exacerbations, which are characterized by severe shortness of breath, persistent cough, fatigue, and swelling of the legs or ankles. Such exacerbations often lead to hospitalization and prolonged care, and are generally associated with poor outcomes.
“Although COPD is the third leading cause of death by disease in the United States, estimated to cost $49 billion in care annually, innovation in COPD care has trailed other disease states,” said Syed Hadi, MD, a Hartford HealthCare hospitalist.
“Acute exacerbations of COPD often result in hospitalization, and a quarter of patients will be readmitted to the hospital within 30 days,” Hadi said.
In the POWER trial (NCT05330507), participants will be provided with 16 weeks (about four months) of the Wellinks platform. This includes a connected spirometer to measure the volume of inhaled and exhaled air, a pulse oximeter to measure blood oxygen levels, virtual respiratory therapist sessions with lung rehabilitation, and coaching sessions. All participants will receive mobile application access and COPD-related education.
The four-month period consists of a 30-day post-discharge period, followed by a three-month intensive program. During the first month, participants will receive virtual respiratory therapist sessions twice a week, along with simultaneous lung rehabilitation. In the three-month period, patients will have virtual health coaching sessions once every two weeks, and the lung rehabilitation program will no longer be held at the same time.
In both phases, participants will have at-home access and use of the connected spirometer, pulse oximeter, and mobile app.
Primary study goals will be to determine the rate of hospital readmission, changes in quality of life, and exercise capacity. The trial also will evaluate patients for shortness of breath and the program’s impact on their daily activities.
Other objectives include assessing mobile app use, as well as the use of the other devices throughout the study period. Participant-reported satisfaction with the management program also will be determined.
According to Wellinks, integrated COPD care can significantly reduce 30-day hospital readmission, as well as the associated costs. Additionally, a small pilot study conducted by the company showed that older adults with COPD found the Wellinks health mobile app useful and valuable for managing the disease.
In collaboration with the COPD Foundation’s COPD Patient-Powered Research Network (COPD PPRN), Wellinks also is conducting a 24-week study. That trial, called ASPIRE (NCT05259280), is assessing the platform’s impact on health-related quality of life, healthcare resource utilization, and lung function.
The trial is currently only enrolling by invitation.