Significance: The proposed research, ?Promoting AdheRence via Objective Technology to Assess Cystic Fibrosis Treatment (PROTRACT)?, will develop a novel, cost?effective system that combines multiple sensing modalities to provide an accurate, practical, and affordable method for reliably assessing adherence to treatment of cystic fibrosis (CF). Problem to be Addressed: CF is a life?shortening disease that results in progressive deterioration of lung function and eventual respiratory failure. Advances in treatment options for thinning and expelling the characteristic thick mucus from the lungs have extended the expected age of survival of CF patients, but the complexity and time burden of treatments contributes to poor adherence. The core of the PROTRACT system is advanced sensing technology that can objectively and accurately track time spent using two of the most commonly prescribed CF treatments for minimizing the effects of mucus: (1) high?frequency chest wall oscillation devices for airway clearance therapy (ACT) that are typically prescribed for use twice daily (30 min sessions each); and (2) nebulizers that provide inhaled medication, prescribed for a similar frequency as ACT. The system offers significant advantages over current measures, which only capture total powered?on time, and therefore fail to determine whether the patient is truly using the devices. Present measures also fail to provide information regarding the pattern of therapy use within each 24?hour interval. An objective and accurate method for measuring patient adherence to these treatments is required to augment clinical effectiveness. Improving adherence will reduce pulmonary exacerbations and slow disease progression Phase I Hypotheses: The proposed Phase I SBIR program will test the hypotheses that the PROTRACT system can accurately track adherent and non?adherent patients during laboratory validation studies. Phase I Summary: Barron Associates, Inc., pioneers in innovative medical sensing technology, has partnered with leaders in the treatment of CF at Virginia Commonwealth University to demonstrate the feasibility of the PROTRACT system. The specific objectives of the Phase I program are to: (1) develop adherence sensing hardware; (2) collect patient data for retrospective assessment; (3) develop the adherence classification algorithms; (4) collect patient data for prospective assessment; and (5) analyze the results of the pilot study. Successful Phase I prototype development will lay the foundation for the Phase II effort, which will focus on development of a commercial product, including an interactive patient?clinician interface and formal evaluation of the PROTRACT system?s efficacy for improving adherence and clinical outcomes. Impact: The system will have a significant overall impact on public health by increasing patient adherence to CF treatment regiments and thereby reducing pulmonary exacerbations, slowing disease progression, and ultimately improving quality of life for patients with CF.
The proposed PROTRACT system objectively determines the duration and pattern of adherence to CF airway clearance and inhaled medication therapies on a minute?by?minute basis and provides feedback of usage metrics to patients and clinicians. The proposed Phase I SBIR research will provide accurate assessment of patient adherence to CF treatments and ease the burden of managing a complex treatment regimen, thereby promoting adherence to critical treatments 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.
