Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Launched by CONVEXITY SCIENTIFIC INC · Apr 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a program called Wellinks, designed to help manage Chronic Obstructive Pulmonary Disease (COPD) for patients who have recently been hospitalized due to a worsening of their condition. The goal is to see if using Wellinks can reduce the number of times patients need to return to the hospital after being discharged. This program includes virtual support and rehabilitation to help patients improve their breathing and overall health.

To participate, individuals must be at least 18 years old and have been recently admitted to the hospital for COPD-related issues. They should also have access to a smartphone and the internet, be able to read and understand English, and live in the United States during the study. Participants will engage in virtual sessions and provide feedback about their experiences. It’s important to note that those with certain health conditions or who are currently pregnant will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult (≥18 years of age with no upper age limit) 2. Any sex, race and ethnicity 3. COPD diagnosis 4. Current hospital admission or observation status resulting from exacerbation of COPD or generally including respiratory signs/symptoms indicative of difficulty breathing (e.g., need for oxygen or nebulized therapy, increased use of rescue medication) 4. Telephone (landline or mobile) and internet access 5. Access to a smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model 6. Proficient in English language due to the availability of all study materials in the English language only 7. Living/staying in the United States throughout the study duration 8. Eligible to participate in asynchronous virtual pulmonary rehabilitation in the opinion of the investigator (e.g., patients determined to be ineligible to participate may include those with acute coronary syndrome for whom an exercise regimen is not advisable at present time) 9. Willing and able to comply with study requirements 10. Able to provide written informed consent
• Exclusion Criteria:
• • 1. Diagnosis of acute decompensated heart failure
• • 2. Currently pregnant or planning to become pregnant during the study period
• • 3. Life expectancy \<17 weeks
• • 4. Current participation in other interventional clinical trials
• • 5. Current participation in a pulmonary rehabilitation program
• • 7. Enrollment in an existing Wellinks program 8. Unable or unwilling to cooperate with remote assessments and engagement with Coaches 9. Unable to comply with the study procedures in the opinion of the investigator (e.g., unlikely to be compliant, unlikely to comprehend instructions or education provided)