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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease Moderate; COPD; Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Severe
• Interventions: Other: Wellinks

• Registration Number: NCT05259280
• Lead Sponsor: Convexity Scientific Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-28
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Wellinks	Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous.
Arm 1	Wellinks	Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.

Primary Outcome Measures

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

Trial Locations

Locations (2)

COPD Foundation; 🇺🇸 Washington, District of Columbia, United States

Wellinks; 🇺🇸 New Haven, Connecticut, United States