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OpenTrials
Completed

NCT Number: NCT05259280

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.

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Key information

Conditions

COPD Chronic Disease Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Moderate Chronic Obstructive Pulmonary Disease Severe Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellinks, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellinks

Other

Digital health and virtual care program for COPD management.

Primary outcomes

  1. COPD Symptoms Assessment

    Time frame: Change from baseline to 12 weeks

    Change in self-reported symptoms as collected in the app.

  2. COPD Symptoms Assessment

    Time frame: Change from baseline to 24 weeks

    Change in self-reported symptoms as collected in the app.

  3. COPD Self-Efficacy Scale

    Time frame: Change from baseline to 12 weeks

    Change in COPD Self-Efficacy Scale

  4. COPD Self-Efficacy Scale

    Time frame: Change from baseline to 24 weeks

    Change in COPD Self-Efficacy Scale

  5. Patient-Reported Healthcare Resource Utilization (HRU)

    Time frame: 12 weeks

    Measure of health resource utilization from period baseline to 12 weeks. Emergency room visits. Hospitalizations.

  6. Patient-Reported Healthcare Resource Utilization (HRU)

    Time frame: 24 weeks

    Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.

  7. Modified Medical Research Council Dyspnea Scale (mMRC)

    Time frame: Change from baseline to 12 weeks

    Change in mMRC score. (0-4, 0 is best)

  8. Modified Medical Research Council Dyspnea Scale (mMRC)

    Time frame: Change from baseline to 24 weeks

    Change in mMRC score. (0-4, 0 is best)

Other outcomes

  1. Participant Net Promoter Score (nPS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Convexity Scientific Inc

Industry

Collaborators

  • COPD Foundation

Registry information

Official study title

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

Acronym: ASPIRE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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