COPDROAMNCT06874101
Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients
A study testing Activated ROAM System with User Feedback in people with COPD and COPD - Chronic Obstructive Pulmonary Disease, run by Barron Associates, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- COPD, COPD - Chronic Obstructive Pulmonary Disease
- What is being tested?
- Activated ROAM System with User Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Yun Shim, MD, 434-924-5219, YSS6N@uvahealth.org
Yun Shim, MD
About this study
Official title: Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy
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.
Read the detailed 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 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
- COPD, COPD - Chronic Obstructive Pulmonary Disease
- Being tested
- Activated ROAM System with User Feedback, Sham Comparator
- Keywords
- oxygen therapy, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated ROAM System with User FeedbackDevice
The activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry.
Sham ComparatorDevice
The sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user.
| Study group | Role | What they receive |
|---|---|---|
| ROAM Group | Experimental | 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. Receives: Device: Activated ROAM System with User Feedback |
| Control Group | Sham comparator | 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. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates of oxygen therapy
Adherence rates are computed as the participant's average daily actual treatment time divided by the prescribed daily treatment time.
Measured: From enrollment through completion of the study at 5 weeks
Secondary outcomes (1)
Patient Activation Model Scores
The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens.
Measured: at the study completion at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eileen Krepkovich, MS, Principal investigator, Barron Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874101
- Sponsor's protocol ID
- ROAM
- Other IDs
- 5R44HL147667-03
- Acronym
- ROAM
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy
- ClinicalTrials.gov ID
- NCT06874101
- Acronym / sponsor ID
- ROAM / ROAM
- Conditions
- COPD, COPD - Chronic Obstructive Pulmonary Disease
- Keywords
- oxygen therapy, COPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROAM Group | Experimental | Device: Activated ROAM System with User FeedbackThe 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. |
| Control Group | Sham comparator | Device: Sham ComparatorThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated ROAM System with User FeedbackThe activated ROAM device will provide the user with daily information about their oxygen therapy usage and pulse oximetry. | Device | ROAM Group |
| Sham ComparatorThe sham comparator is a ROAM device that monitors oxygen usage, but keeps the usage details blind to the user. | Device | Control Group |
Primary outcome
Adherence rates of oxygen therapy
Time frame: 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.
1 secondary outcome
Patient Activation Model Scores
Time frame: at the study completion at 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eileen Krepkovich, MS principal investigator
Barron Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated ROAM System with User Feedback in people with COPD and COPD - Chronic Obstructive Pulmonary Disease, run by Barron Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen Krepkovich, MS (434-973-1215 ext. 123, krepkovich@barron-associates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rates of oxygen therapy (time frame: From enrollment through completion of the study at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.