Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Launched by BARRON ASSOCIATES, INC. · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial will be a conventional randomized, parallel controlled trial to evaluate the primary hypothesis that a 4-week period of using the ROAM adherence monitor and support system will result in increased adherence when compared to a control group with no adherence monitoring. The participant population will be individuals with chronic obstructive pulmonary disease (COPD), and who have been prescribed oxygen therapy for a minimum of 8 hours/day. Half of the participants will be randomly assigned to the ROAM group; the other half will comprise the control group.

All participants...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Post-Bronchodilator FEV1/FVC\<.80
• • Participants with medical history of COPD
• • Prescription for oxygen use via nasal cannula or mask at home
• • At baseline of health with no hospitalization/exacerbation within the past 6 weeks
• • Use of Continuous oxygen at baseline
• Exclusion Criteria:
• • Post -Bronchodilator FEV1/FVC ≤25%
• • Intermittent oxygen use at home
• • Inability to understand simple instructions
• • Respiratory exacerbation or infections within 6 weeks prior to screen visit
• • Not at baseline of medical health prior to screen visit

Trial Officials