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

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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; COPD; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Other: Wellinks

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Wellinks
  • District of Columbia
    • Washington, District of Columbia, United States, 20002
      • COPD Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution.	Other: Wellinks; Digital health and virtual care program for COPD management.
Experimental: Arm 2; Arm 1: Subjects will receive 24 weeks of access to the Wellinks Solution. The latter 12 weeks will be entirely asynchronous.	Other: Wellinks; Digital health and virtual care program for COPD management.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Net Promoter Score (nPS)	Measure of the Net Promoter Score - (How likely are you to recommend wellinks to a friend or family member?). Scale: -100 to +100, higher is better.	24 weeks

Collaborators and Investigators

• Sponsor: Convexity Scientific Inc
• Collaborators: COPD Foundation
• Investigators: Study Director: Gretchen McCreary, COPD Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: COPD; Digital Health; Virtual Care; V1C
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WL-2021-02-COPDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No