Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy
Barron Associates, Inc.
Summary
The goal of this clinical trial is to test a device called "ROAM" that is being developed to see how patients with chronic obstructive pulmonary disease (COPD) use oxygen therapy over a long period of time. This study will focus on evaluating the ROAM device, which will be attached to your oxygen source. The question that the study aims to answer is: will patients who receive daily adherence feedback from the ROAM have increased adherence to their prescribed long term oxygen therapy regimens? Researchers will compare the amount of time using oxygen and attitudes about oxygen therapy observed in a group that receives feedback from ROAM, and a control group that does not receive feedback. Participants will have their oxygen supplies fitted with the ROAM device and then use their oxygen as usual for the 5-week study duration. Participants in the study group will have access to information about their oxygen usage and pulse oximetry levels. All participants will attend two in-clinic sessions of about an hour each, and will complete questionnaires at the beginning and end of the study.
Description
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 wi…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceActivated ROAM System with User Feedback
The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.
- DeviceSham Comparator
The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.
Location
- University of VirginiaCharlottesville, Virginia