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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; COPD; Respiratory Tract Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: William Roman; Phone Number: 860-972-1558; Email: William.Roman@hhchealth.org
• Study Contact Backup: Name: Syed Hadi, MD; Phone Number: 860-972-0546; Email: syed.hadi@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
      • Contact: Syed Hadi, MD; Phone Number: 860-972-0546

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with COPD hospitalized due to a COPD exacerbation are eligible for enrollment into the Wellinks intervention. Study participants are required to fulfill certain criteria for access to the internet and a smartphone. Key exclusion criteria are congestive heart failure for the potential risk to participation in virtual pulmonary rehabilitation, coincident SARS-CoV-2 infection due to the unknown impact on the post-discharge outcomes of COPD patients, and current participation in other interventional programs or active engagement in pulmonary rehabilitation. See complete list of eligibility criteria.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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).

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value Ranking of Wellinks Features	Value ranking of the various components of Wellinks	16 weeks

Collaborators and Investigators

• Sponsor: Convexity Scientific Inc
• Collaborators: Hartford HealthCare
• Investigators: Principal Investigator: Syed Hadi, MD, Hartford Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Exacerbation; Digital Health; Hospitalization; Readmission; Virtual Care; Discharge; V1C
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases
• Other Study ID Numbers: WL-2022-01-HHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No