COPD, Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiratory Tract Disease
Conditions
Keywords
Exacerbation, Discharge, Hospitalization, Readmission, Virtual Care, Digital Health, V1C
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 (COPD) management solution, for patients recently discharged from the hospital due to an acute exacerbation of their COPD.
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 virtual pulmonary rehabilitation, all centralized by the use of a mobile-phone application (mobile app) downloaded onto a study participant's iOS (iPhone) or Android device. The clinical objectives of this study are to determine whether utilization of Wellinks can reduce the rate of hospital readmissions due to a COPD exacerbation for patients recently discharged from the hospital. The nonclinical objectives of this study are to describe the experience of study participants using Wellinks through the assessment of engagement with the components of Wellinks, as well as by participant-reported satisfaction and perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of Wellinks will be solicited.
Interventions
OTHERWellinks
30-day post-discharge period: virtual respiratory therapist sessions twice per week with synchronous virtual pulmonary rehabilitation and educational materials; at-home use of connected spirometer and pulse oximeter; at-home use of mobile app. 12-week intensive period: virtual health coaching sessions once every two weeks; asynchronous virtual pulmonary rehabilitation program; ongoing access to connected devices (spirometer and pulse oximeter) and mobile app.
Sponsors
Hartford HealthCare
Convexity Scientific Inc
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission rate (COPD-related) | 30-days post-discharge from index event | Rate of COPD-related hospital readmission |
| COPD Assessment Test | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | Assess quality-of-life impact of COPD |
| Exercise capacity: 30-second sit-to-stand | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | Assess exercise capacity |
| Modified Medical Research Council Dyspnea Index (mMRC) | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | Assess shortness of breath and impact on daily activities |
| Hospital readmission rate (all-cause) | 30-days post-discharge from index event | Rate of all-cause hospital readmission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wellinks App Engagement | 16 weeks | Frequency of use of the mobile app throughout the study period |
| Wellinks Device Engagement | 16 weeks | Frequency of use of the connected devices throughout the study period |
| Wellinks Session Engagement | 16 weeks | Participation rate in scheduled respiratory therapist and health coaching sessions |
| Patient Satisfaction (Net Promoter Score) | 16 weeks | Net promoter score from asking, How likely is it that you would recommend Wellinks to a friend or colleague? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Value Ranking of Wellinks Features | 16 weeks | Value ranking of the various components of Wellinks |
Countries
United States
Contacts
Primary ContactSyed Hadi, MD
Backup ContactWilliam Roman
Outcome results
None listed