Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients
NCT ID: NCT06874101
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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All participants will bring their regular oxygen supplies to the clinic to be fitted with the ROAM sensors. To establish baseline adherence, for the first week, all participants will be blinded to feedback from the ROAM system (including oxygen usage times and oxygen saturation levels); a special code will disable feedback on the local system, including the adherence displays and notifications. After one week, the oxygen usage times will be averaged, and used as a baseline of adherence.
Control participants will continue to be blinded to the ROAM feedback for the next four weeks. After the first week, the ROAM group participants will be instructed to enter a code to enable the ROAM user feedback display on the concentrator and portable tank systems. These participants will be instructed to take pulse oximetry readings as they usually do using the ROAM system's included oximeter. A minimum of two readings per day will be encouraged by built-in alerts on the system. They will continue using the system, while receiving feedback on daily adherence rates and oxygen saturation levels, for the 4-week study duration.
The average daily oxygen use times over the four-week study period will be computed, and use times for the ROAM group will be compared to those of the control group. At the beginning and end of the study, patients will complete a questionnaire to assess attitudes toward treatment. The primary outcome metric will be adherence rates (% adherent = actual treatment time/prescribed treatment time) of the oxygen therapy. The secondary outcome metric will be attitude towards treatment, as assessed via questionnaires.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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ROAM Group
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.
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.
Control Group
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.
Sham Comparator
The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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University of Virginia
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Barron Associates, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eileen Krepkovich, MS
Role: PRINCIPAL_INVESTIGATOR
Barron Associates
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROAM
Identifier Type: -
Identifier Source: org_study_id
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