Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Study Overview
=================
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.

Official Title
-----------------
POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Conditions
-----------------
COPD, Respiratory Tract Disease, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Lung Diseases

Intervention / Treatment
-----------------
* Other: Wellinks


Participation Criteria
=================
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: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wellinks Intervention<br>Following inpatient hospitalization for COPD exacerbation, participants will receive 16 weeks of access to Wellinks (i.e., connected spirometer and pulse oximeter, virtual respiratory therapist sessions with pulmonary rehabilitation, virtual health coaching sessions, mobile app access, COPD-related education). The 16-week period is comprised of a 30-day post-discharge program followed by a 12-week intensive period, which vary by frequency of contact with respiratory therapists/health coaches. | Other: Wellinks<br>* 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.<br>|
| Matched Controls<br>A matched control dataset will be extracted from electronic medical records of the participating healthcare system. Participants will be matched on an index COPD-related hospitalization and other key factors, utilizing propensity score matching (i.e., number of COPD-related hospitalizations in prior year, severity of COPD, age). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate (all-cause) | Rate of all-cause hospital readmission | 30-days post-discharge from index event | 
| Hospital readmission rate (all-cause) | Rate of all-cause hospital readmission | 60-days post-discharge from index event | 
| Hospital readmission rate (all-cause) | Rate of all-cause hospital readmission | 90-days post-discharge from index event | 
| Hospital readmission rate (COPD-related) | Rate of COPD-related hospital readmission | 30-days post-discharge from index event | 
| Hospital readmission rate (COPD-related) | Rate of COPD-related hospital readmission | 60-days post-discharge from index event | 
| Hospital readmission rate (COPD-related) | Rate of COPD-related hospital readmission | 90-days post-discharge from index event | 
| COPD Assessment Test | Assess quality-of-life impact of COPD | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | 
| Exercise capacity: 30-second sit-to-stand | Assess exercise capacity | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | 
| Modified Medical Research Council Dyspnea Index (mMRC) | Assess shortness of breath and impact on daily activities | Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellinks App Engagement | Frequency of use of the mobile app throughout the study period | 16 weeks | 
| Wellinks Device Engagement | Frequency of use of the connected devices throughout the study period | 16 weeks | 
| Wellinks Session Engagement | Participation rate in scheduled respiratory therapist and health coaching sessions | 16 weeks | 
| Patient Satisfaction (Net Promoter Score) | Net promoter score from asking, How likely is it that you would recommend Wellinks to a friend or colleague? | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exacerbation, Discharge, Hospitalization, Readmission, Virtual Care, Digital Health, V1C