Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

Recruiting

• Conditions: COPD; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Disease; Lung Diseases, Obstructive; Lung Diseases
• Interventions: Other: Wellinks

• Registration Number: NCT05330507
• Lead Sponsor: Convexity Scientific Inc

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.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-15
• Study Start: 2022-07-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

6. 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wellinks Intervention	Wellinks	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.

Primary Outcome Measures

Name	Time	Method
Hospital readmission rate (all-cause)	90-days post-discharge from index event	Rate of all-cause hospital readmission
Hospital readmission rate (COPD-related)	90-days post-discharge from index event	Rate of COPD-related hospital readmission
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
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

Secondary Outcome Measures

Name	Time	Method
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?"
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

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States