Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

ConditionsCOPD COPD - Chronic Obstructive Pulmonary Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorBarron Associates, Inc.

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: ROAM GroupExperimental treatment 1 intervention

Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment through completion of the study at 5 weeks

Secondary outcomes

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.

Time frame

at the study completion at 5 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barron Associates, Inc.

Lead sponsor

University of Virginia

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)