Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD

Study Overview
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Brief Summary
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The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices. The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.

Official Title
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ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD

Conditions
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COPD, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Severe, Chronic Obstructive Pulmonary Disease Moderate

Intervention / Treatment
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* Other: Wellinks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD diagnosis (confirmed by the patient and assumed based on participation in COPD PPRN) Home telephone (landline or mobile) and internet access Smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model Proficient in English language Living/staying in the United States throughout the study duration Willing and able to comply with study requirements Able to provide written informed consent Exclusion Criteria: Current participation in other interventional clinical trials Current participation in a pulmonary rehabilitation program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. | Other: Wellinks<br>* Digital health and virtual care program for COPD management.<br>|
| Experimental: Arm 2<br>Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous. | Other: Wellinks<br>* Digital health and virtual care program for COPD management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Symptoms Assessment | Change in self-reported symptoms as collected in the app. | Change from baseline to 12 weeks | 
| COPD Symptoms Assessment | Change in self-reported symptoms as collected in the app. | Change from baseline to 24 weeks | 
| COPD Self-Efficacy Scale | Change in COPD Self-Efficacy Scale | Change from baseline to 12 weeks | 
| COPD Self-Efficacy Scale | Change in COPD Self-Efficacy Scale | Change from baseline to 24 weeks | 
| Patient-Reported Healthcare Resource Utilization (HRU) | Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations. | 12 weeks | 
| Patient-Reported Healthcare Resource Utilization (HRU) | Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations. | 24 weeks | 
| Modified Medical Research Council Dyspnea Scale (mMRC) | Change in mMRC score. (0-4, 0 is best) | Change from baseline to 12 weeks | 
| Modified Medical Research Council Dyspnea Scale (mMRC) | Change in mMRC score. (0-4, 0 is best) | Change from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Virtual Care, Digital Health, V1C