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Respiratory Oxygen Adherence Monitor for Chronic Obstructive Pulmonary Disease Patients

Evaluating a Respiratory Oxygen Adherence Monitor for COPD Patients With Long-term Oxygen Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "At the beginning and end of the study, patients will complete a questionnaire to assess attitudes toward treatment."
  • "The secondary outcome metric will be attitude towards treatment, as assessed via questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

VA