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

Sponsor

Convexity Scientific Inc (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05259280

Collaborator

COPD Foundation (Other)

150

Enrollment

Locations

Arms

10.8

Anticipated Duration (Months)

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease Moderate	Other: Wellinks	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

Participant Net Promoter Score (nPS) [24 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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