Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions

COPD Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330507
• Other study ID #: WL-2022-01-HHC
• Status: Recruiting
• Start date: July 5, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Convexity Scientific Inc
• Contact: Syed Hadi, MD
• Phone: 860-972-0546
• Email: syed.hadi[@]hhchealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Disease
• Respiratory Tract Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Convexity Scientific Inc	Hartford HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Value Ranking of Wellinks Features	Value ranking of the various components of Wellinks	16 weeks
Primary	Hospital readmission rate (all-cause)	Rate of all-cause hospital readmission	30-days post-discharge from index event
Primary	Hospital readmission rate (all-cause)	Rate of all-cause hospital readmission	60-days post-discharge from index event
Primary	Hospital readmission rate (all-cause)	Rate of all-cause hospital readmission	90-days post-discharge from index event
Primary	Hospital readmission rate (COPD-related)	Rate of COPD-related hospital readmission	30-days post-discharge from index event
Primary	Hospital readmission rate (COPD-related)	Rate of COPD-related hospital readmission	60-days post-discharge from index event
Primary	Hospital readmission rate (COPD-related)	Rate of COPD-related hospital readmission	90-days post-discharge from index event
Primary	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)
Primary	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)
Primary	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	Wellinks App Engagement	Frequency of use of the mobile app throughout the study period	16 weeks
Secondary	Wellinks Device Engagement	Frequency of use of the connected devices throughout the study period	16 weeks
Secondary	Wellinks Session Engagement	Participation rate in scheduled respiratory therapist and health coaching sessions	16 weeks
Secondary	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