Status:
UNKNOWN
Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
Lead Sponsor:
Convexity Scientific Inc
Collaborating Sponsors:
Hartford HealthCare
Conditions:
COPD
Respiratory Tract Disease
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, observational study is designed to investigate clinical outcomes and collect patient feedback on the use of Wellinks, an integrated virtual chronic obstructive pulmonary disease (COP...
Detailed Description
Wellinks, an integrated virtual COPD management solution consists of a combination of health coaching, Bluetooth-connected devices, collection of patient-reported symptoms and medication use, and virt...
Eligibility Criteria
Inclusion
- 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
- Diagnosis of acute decompensated heart failure
- Currently pregnant or planning to become pregnant during the study period
- Life expectancy \<17 weeks
- Current participation in other interventional clinical trials
- 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)
Key Trial Info
Start Date :
July 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05330507
Start Date
July 5 2022
End Date
June 1 2024
Last Update
November 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hartford Hospital
Hartford, Connecticut, United States, 06102