Clinical trial NCT05259280: Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
Official title: ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease Severe
Chronic Obstructive Pulmonary Disease Moderate
Keywords: COPD
Virtual Care
Digital Health
V1C
Lead sponsor: Convexity Scientific Inc
Sponsor class: INDUSTRY
Collaborators: name: COPD Foundation
First posted: 2022-02-28
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: COPD Symptoms Assessment
timeFrame: Change from baseline to 12 weeks
measure: COPD Symptoms Assessment
timeFrame: Change from baseline to 24 weeks
measure: COPD Self-Efficacy Scale
timeFrame: Change from baseline to 12 weeks
measure: COPD Self-Efficacy Scale
timeFrame: Change from baseline to 24 weeks
measure: Patient-Reported Healthcare Resource Utilization (HRU)
timeFrame: 12 weeks
measure: Patient-Reported Healthcare Resource Utilization (HRU)
timeFrame: 24 weeks
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Change from baseline to 12 weeks
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
Other outcomes:
measure: Participant Net Promoter Score (nPS)
timeFrame: 24 weeks
Locations:
city: New Haven
country: United States
facility: Wellinks
state: Connecticut
city: Washington
country: United States
facility: COPD Foundation
state: District of Columbia
Study officials:
affiliation: COPD Foundation
name: Gretchen McCreary
role: STUDY_DIRECTOR
References: