Introduction: The Respiratory Oxygen Adherence Monitor (ROAM) system will provide an effective, practical, and affordable method to reliably assess long term oxygen therapy (LTOT) adherence. Problem to be Addressed: Chronic obstructive pulmonary disease (COPD) afflicts over 15 million people in the United States a n d is responsible for over 500,000 hospitalizations and over 100,000 deaths annually. LTOT, which is generally administered to patients via a nasal cannula attached to an oxygen source, is the only treatment that has been shown to improve survival in severe hypoxemia due to cardiopulmonary disease. The improvement in mortality is greatest when oxygen therapy is used at least 16 hours/day. LTOT is also associated with significant reductions in hospitalizations and lengths of stay, and improved quality of life. Despite the benefits of LTOT, adherence remains a challenge in the majority of patients. Furthermore, the ability to accurately assess rates of patient LTOT adherence is limited by current measures, such as power?on time of the concentrator, which fail to discern whether the patient is actually wearing the nasal cannula and inhaling oxygen, as opposed to merely having the oxygen source turned on. Present measures also fail to provide information regarding the pattern of oxygen use within each 24?hour interval. An objective and accurate method for measuring patient adherence to LTOT is required to augment clinical effectiveness. Research Hypotheses: The SBIR Phase I program will test the hypothesis that the ROAM system can accurately track adherent and non?adherent patients during laboratory validation studies. Phase I Summary: In the proposed research effort, the team will develop a commercial?ready ROAM system using hardware components and the inclusion of a software interface that enables patients and authorized healthcare providers to access to patients' adherence data, including pulse oximetry measures. The system will provide patients with informational, attentional, and motivational feedback to encourage and improve adherence. User?design processes will be implemented for hardware and software development to ensure usability and motivational relevance with the target patient population. The Phase II program will culminate in an extensive field trial involving COPD patients to demonstrate system efficacy. Public Health Impact: The ROAM system will increase LTOT adherence, lead to improved health outcomes for patients with cardiopulmonary disease, and reduce the healthcare costs that are associated with expensive and preventable hospitalizations due to non?adherence.
Public Health Relevance Statement: PROJECT NARRATIVE The proposed ROAM system objectively determines the duration and pattern of adherence to oxygen therapy on a minute?by?minute basis and provides feedback of usage metrics to patients and clinicians. The proposed SBIR research addresses an important public health concern by providing accurate assessment of patient adherence to oxygen therapy and promoting adherence to a treatment that many patients neglect. The ultimate impact will be to improve health outcomes and reduce the costs associated with expensive and preventable hospitalizations due to non?adherence.
NIH Spending Category: Behavioral and Social Science; Bioengineering; Chronic Obstructive Pulmonary Disease; Clinical Research; Clinical Trials and Supportive Activities; Health Services; Lung; Patient Safety
Project Terms: Address; Adherence; Algorithms; Attention; base; Breathing; Cannulas; care providers; Cessation of life; Chronic Obstructive Airway Disease; Clinical effectiveness; Clinical Management; Communication; compliance behavior; Computer software; Control Groups; cost; Cost Savings; Data; design; Detection; Ensure; Failure; Feedback; Frequencies; Health; Health Care Costs; Health Personnel; Healthcare Systems; Hospitalization; Hour; Hypoxemia; improved; improved outcome; Inhalation; innovation; Laboratories; Lead; Length of Stay; Link; Literature; Measurement; Measures; Methods; Modality; Monitor; Morbidity - disease rate; mortality; Motivation; neglect; Nose; novel; Outcome; Oxygen; Oxygen Therapy Care; Patient Care; Patient Noncompliance; patient population; Patient-Focused Outcomes; Patients; Pattern; Phase; phase 1 study; phase 2 study; Physiologic pulse; pressure; Prevalence; Process; programs; prototype; Public Health; Pulmonary Heart Disease; Pulse Oximetry; Quality of life; Research; respiratory oxygen; Small Business Innovation Research Grant; Societies; software development; Source; System; Testing; therapy adherence; Time; time use; United States; usability; user centered design; validation studies; visual feedback; Wireless Technology
