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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05259280
Other study ID # WL-2021-02-COPDF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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