ROAM System for COPD
(ROAM Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByEileen Krepkovich, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Barron Associates, Inc.

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for people with chronic obstructive pulmonary disease (COPD) who use long-term oxygen therapy. Participants should be willing to have their oxygen supply monitored and attend two clinic sessions. Specific eligibility criteria are not provided, but typically include being diagnosed with COPD and using prescribed oxygen.

Inclusion Criteria

I haven't been hospitalized or had a health flare-up in the last 6 weeks.

I need to use oxygen all the time.

Post-Bronchodilator FEV1/FVC less than 0.80

+2 more

Exclusion Criteria

Inability to understand simple instructions

Not at baseline of medical health prior to screen visit

I haven't had lung infections or worsening symptoms in the last 6 weeks.

+2 more

Participant Groups

The study tests the 'ROAM' device's effectiveness in improving adherence to prescribed oxygen therapy among COPD patients. It compares feedback on usage from ROAM against a control group without feedback over a 5-week period, measuring time spent on oxygen and attitudes towards therapy.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ROAM GroupExperimental Treatment1 Intervention

The ROAM group participants will have access to the ROAM user feedback display on their concentrator and portable tank oxygen delivery systems, throughout the 4-week study duration.

Group II: Control GroupPlacebo Group1 Intervention

The control group participants will have their oxygen delivery concentrators and portable tanks fitted with the ROAM system, which will monitor their usage, but they will not receive any of the user feedback or have access to the ROAM software.