ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 153
- Locations
- 4
- Primary Endpoint
- Patient-Reported Healthcare Resource Utilization (HRU)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient-Reported Healthcare Resource Utilization (HRU)
Time Frame: 24 weeks
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Modified Medical Research Council Dyspnea Scale (mMRC)
Time Frame: Change from baseline to 24 weeks
Change in mMRC score. (0-4, 0 is best)
COPD Self-Efficacy Scale
Time Frame: Change from baseline to 24 weeks
Change in COPD Self-Efficacy Scale
COPD Symptoms Assessment
Time Frame: Change from baseline to 24 weeks
Change in self-reported symptoms as collected in the app.
Secondary Outcomes
No secondary outcomes reported