Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBarron Associates, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Activated ROAM System with User Feedback
  • Sham Comparator

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Barron Associates, Inc.

Lead sponsor

University of Virginia

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator