Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe, COPD
Conditions
Keywords
COPD, Virtual Care, Digital Health, V1C
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.
Interventions
OTHERWellinks
Digital health and virtual care program for COPD management.
Sponsors
COPD Foundation
Convexity Scientific Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Symptoms Assessment | Change from baseline to 12 weeks | Change in self-reported symptoms as collected in the app. |
| COPD Self-Efficacy Scale | Change from baseline to 12 weeks | Change in COPD Self-Efficacy Scale |
| Patient-Reported Healthcare Resource Utilization (HRU) | 12 weeks | Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations. |
| Modified Medical Research Council Dyspnea Scale (mMRC) | Change from baseline to 12 weeks | Change in mMRC score. (0-4, 0 is best) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant Net Promoter Score (nPS) | 24 weeks | Measure of the Net Promoter Score - (How likely are you to recommend wellinks to a friend or family member?). Scale: -100 to +100, higher is better. |
Countries
United States
Outcome results
None listed