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

Convexity Scientific

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Moderate; COPD; Chronic Obstructive Pulmonary Disease Severe

Treatments: Other: Wellinks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05259280

WL-2021-02-COPDF

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Arm 1

Experimental group

Description:

Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.

Treatment:

Other: Wellinks

Arm 2

Experimental group

Description:

Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous.

Treatment:

Other: Wellinks