Clinical trial NCT05330507: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
Official title: POWER: Prospective, Observational Study of Wellinks Effect on COPD Hospital Readmissions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Respiratory Tract Disease
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Keywords: Exacerbation
Discharge
Hospitalization
Readmission
Virtual Care
Digital Health
V1C
Lead sponsor: Convexity Scientific Inc
Sponsor class: INDUSTRY
Collaborators: name: Hartford HealthCare
First posted: 2022-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hospital readmission rate (all-cause)
timeFrame: 30-days post-discharge from index event
measure: Hospital readmission rate (all-cause)
timeFrame: 60-days post-discharge from index event
measure: Hospital readmission rate (all-cause)
timeFrame: 90-days post-discharge from index event
measure: Hospital readmission rate (COPD-related)
timeFrame: 30-days post-discharge from index event
measure: Hospital readmission rate (COPD-related)
timeFrame: 60-days post-discharge from index event
measure: Hospital readmission rate (COPD-related)
timeFrame: 90-days post-discharge from index event
measure: COPD Assessment Test
timeFrame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
measure: Exercise capacity: 30-second sit-to-stand
timeFrame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
measure: Modified Medical Research Council Dyspnea Index (mMRC)
timeFrame: Change from baseline to day 30 (end of post-discharge intervention phase) and to week 16 (end of study)
Secondary outcomes:
measure: Wellinks App Engagement
timeFrame: 16 weeks
measure: Wellinks Device Engagement
timeFrame: 16 weeks
measure: Wellinks Session Engagement
timeFrame: 16 weeks
measure: Patient Satisfaction (Net Promoter Score)
timeFrame: 16 weeks
Other outcomes:
measure: Value Ranking of Wellinks Features
timeFrame: 16 weeks
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford HealthCare
name: Syed Hadi, MD
role: PRINCIPAL_INVESTIGATOR
References: