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

Convexity Scientific Inc153 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

153

Conditions

COPD Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease Moderate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

COPD Symptoms Assessment

Change in self-reported symptoms as collected in the app.

Time frame: Change from baseline to 12 weeks

COPD Symptoms Assessment

Change in self-reported symptoms as collected in the app.

Time frame: Change from baseline to 24 weeks

COPD Self-Efficacy Scale

Change in COPD Self-Efficacy Scale

Time frame: Change from baseline to 12 weeks

COPD Self-Efficacy Scale

Change in COPD Self-Efficacy Scale

Time frame: Change from baseline to 24 weeks

Patient-Reported Healthcare Resource Utilization (HRU)

Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.

Time frame: 12 weeks

Patient-Reported Healthcare Resource Utilization (HRU)

Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.

Time frame: 24 weeks

Modified Medical Research Council Dyspnea Scale (mMRC)

Change in mMRC score. (0-4, 0 is best)

Time frame: Change from baseline to 12 weeks

Modified Medical Research Council Dyspnea Scale (mMRC)

Change in mMRC score. (0-4, 0 is best)

Time frame: Change from baseline to 24 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes