Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Activated ROAM System with User Feedback: The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.

Sham Comparator: The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.

Study 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.

Eligibility

Primary outcome measure(s)

• Adherence rates of oxygen therapy — From enrollment through completion of the study at 5 weeks
  Adherence rates are computed as the participant's average daily actual treatment time divided by the prescribed daily treatment time.

Trial sites (1)

More Barron Associates, Inc. trials in the USA

Other trials for the same condition