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

Sponsor

Convexity Scientific Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05330507

Collaborator

Hartford HealthCare (Other)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Respiratory Tract Disease Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases	Other: Wellinks

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Wellinks Intervention 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 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.
Matched Controls 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).

Arm

Intervention/Treatment

Wellinks Intervention

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

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.

Matched Controls

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).

Outcome Measures

Primary Outcome Measures

Hospital readmission rate (all-cause) [30-days post-discharge from index event]
Rate of all-cause hospital readmission
Hospital readmission rate (all-cause) [60-days post-discharge from index event]
Rate of all-cause hospital readmission
Hospital readmission rate (all-cause) [90-days post-discharge from index event]
Rate of all-cause hospital readmission
Hospital readmission rate (COPD-related) [30-days post-discharge from index event]
Rate of COPD-related hospital readmission
Hospital readmission rate (COPD-related) [60-days post-discharge from index event]
Rate of COPD-related hospital readmission
Hospital readmission rate (COPD-related) [90-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 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 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 end of study]
Assess shortness of breath and impact on daily activities

Secondary Outcome Measures

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 Outcome Measures

Value Ranking of Wellinks Features [16 weeks]
Value ranking of the various components of Wellinks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult (≥18 years of age with no upper age limit)
Any sex, race and ethnicity
COPD diagnosis and current hospital admission resulting from exacerbation of COPD
Telephone (landline or mobile) and internet access
Access to a smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model
Proficient in English language due to the availability of all study materials in the English language only
Living/staying in the United States throughout the study duration
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)
Willing and able to comply with study requirements
Able to provide written informed consent

Exclusion Criteria:

Diagnosis of congestive heart failure
Coincident SARS-CoV-2 infection at the time of hospitalization
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
Enrollment in an existing Wellinks program
Unable or unwilling to cooperate with remote assessments and engagement with Coaches
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)