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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

Wellinks

Intervention Type OTHER

Digital health and virtual care program for COPD management.

Arm 2

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

Group Type EXPERIMENTAL

Wellinks

Intervention Type OTHER

Digital health and virtual care program for COPD management.

Interventions

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Wellinks

Digital health and virtual care program for COPD management.

Intervention Type OTHER

Eligibility Criteria

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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