Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

NCT06874101 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: ROAM5R44HL147667-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; COPD - Chronic Obstructive Pulmonary Disease

Keywords

oxygen therapy; COPD

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment through completion of the study at 5 weeks

Secondary Outcomes (1)

• Patient Activation Model Scores

  at the study completion at 5 weeks

Study Arms (2)

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.

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.

Device: Sham Comparator

Interventions

Activated ROAM System with User Feedback DEVICE

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

ROAM Group

Sham Comparator DEVICE

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

Control Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of Virginia: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eileen Krepkovich, MS

  Barron Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Krepkovich, MS

CONTACT

434-973-1215; krepkovich@barron-associates.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 13, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)