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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05330507
Other study ID # WL-2022-01-HHC
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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