ROAM System for COPD

(ROAM Trial)

Overseen By Eileen Krepkovich, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barron Associates, Inc.

Disqualifiers: Intermittent oxygen use, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the ROAM System for COPD trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on your oxygen use, so you may not need to change your other treatments, but it's best to confirm with the study team.

What data supports the effectiveness of the ROAM treatment for COPD?

The RECEIVER trial suggests that digital tools, like the ROAM system, can help manage COPD by improving patient engagement and clinical outcomes when used alongside regular care. Additionally, studies on telemedicine and telerehabilitation systems show that these technologies can enhance quality of life and functional capacity in COPD patients. ^{1 2 3 4 5}

Is the ROAM System for COPD safe for humans?

The available research does not provide specific safety data for the ROAM System for COPD. However, general safety monitoring systems like EudraVigilance and adverse event tracking systems are used to ensure the safety of medicines and treatments by identifying and analyzing adverse reactions. ^{6 7 8 9 10}

How is the ROAM treatment for COPD different from other treatments?

The ROAM treatment for COPD is unique because it likely involves a system that automatically adjusts oxygen flow to the patient's needs during activities, similar to the FreeO2 system, or enhances exercise capacity and mobility like the NIOV system. These features can improve daily living activities and quality of life compared to standard oxygen therapy. ^{11 12 13 14 15}

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.

Research Team

Eileen Krepkovich, MS

Principal Investigator

Barron Associates

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants' oxygen supplies are fitted with the ROAM device, and baseline adherence is established over one week without feedback.

1 week

1 visit (in-person)

Treatment

Participants use the ROAM device for 4 weeks. The ROAM group receives feedback on oxygen usage, while the control group does not.

4 weeks

1 visit (in-person)

Follow-up

Participants complete a questionnaire to assess attitudes toward treatment and adherence is evaluated.

1 week

Treatment Details

Interventions

• ROAM

Trial Overview 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.

Participant Groups

Group I: ROAM Group Experimental Treatment 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Barron Associates, Inc.

Lead Sponsor

Trials

11

Recruited

520+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The RECEIVER trial demonstrated that a digital COPD support service led to high and sustained utilization among participants, with 64 out of 83 using the application regularly over an average follow-up of 78 weeks.

Participants using the digital service experienced significantly better clinical outcomes, including a longer median time to death or respiratory-related hospital admission (335 days vs 155 days in the control group) and a greater reduction in annual hospital bed days (8.12 days vs 3.38 days).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Usage and Improved Clinical Outcomes with Adoption of a COPD Digital Support Service: Key Findings from the RECEIVER Trial. Taylor, A., Cushing, A., Dow, M., et al.[2023]

The West Wales Adverse Drug Reaction (ADR) Profile significantly increased the identification of medication-related problems in patients with chronic respiratory diseases, with an average increase of 20.5 problems per participant compared to a decrease in the control group.

The use of the ADR Profile also led to a higher number of nursing actions taken, with a median increase of 2.5 actions per participant in the intervention group, suggesting it enhances medication management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. Gabe, ME., Murphy, F., Davies, GA., et al.[2021]

EudraVigilance, the European pharmacovigilance database, has been crucial for monitoring the safety of medicines since its launch in 2001, with 50% of scientific publications using its data to describe safety issues.

Recent enhancements to EudraVigilance, including broader access to data and improved functionalities, aim to facilitate better safety monitoring and support health research, ultimately promoting the safe and effective use of medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Postigo, R., Brosch, S., Slattery, J., et al.[2021]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The innovative FreeO2 system significantly improved oxygen saturation levels in COPD patients during walking, maintaining SpO2 within the target range of 92-96% more effectively than fixed oxygen flow or room air, with only 0.6% of time spent in severe desaturation compared to 23.9% and 52.2% for the other conditions.

Patients using FreeO2 were able to walk 63% further than when breathing room air, indicating that automatic oxygen adjustment not only enhances oxygenation but may also improve exercise tolerance during daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Lellouche, F., L'Her, E., Bouchard, PA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

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2. United States pubmed.ncbi.nlm.nih.gov

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Defining patient-centered characteristics of a telerehabilitation system for patients with COPD. [2013]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Usage and Improved Clinical Outcomes with Adoption of a COPD Digital Support Service: Key Findings from the RECEIVER Trial. [2023]

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Inferring COPD Severity from Tidal Breathing. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]

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9. England pubmed.ncbi.nlm.nih.gov

Adverse events in healthcare: learning from mistakes. [2022]

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The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of a Highly Portable Noninvasive Open Ventilation System on Activities of Daily Living in Patients with COPD. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Ambulatory oxygen: why do COPD patients not use their portable systems as prescribed? A qualitative study. [2022]

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14. United States pubmed.ncbi.nlm.nih.gov

Daily utility and satisfaction with rollators among persons with chronic obstructive pulmonary disease. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. [2022]