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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259280
• Other study ID #: WL-2021-02-COPDF
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2023
• Source: Convexity Scientific Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Chronic Obstructive Pulmonary Disease Moderate
• Chronic Obstructive Pulmonary Disease Severe
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Wellinks
Digital health and virtual care program for COPD management.

Locations

Country	Name	City	State
United States	Wellinks	New Haven	Connecticut
United States	COPD Foundation	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Convexity Scientific Inc	COPD Foundation

Country where clinical trial is conducted

United States, 

Outcome

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