None listed
Conditions
Brief summary
ResApp Health Limited has developed an innovative smartphone-based software application (COPDCheck) to screen adults for COPD. COPDCheck analyzes patient cough sounds together with a few simple questions asked of the patient and instantaneously reports a diagnosis. In this study we plan to test the COPDCheck diagnostic algorithms and application at the Geraldton Regional Aboriginal Medical Service with the goal of investigating its clinical performance and usage when compared to standard-of-care clinical diagnosis in an Indigenous Australian population. This study is important to validate the algorithms more broadly as previous Australian studies have not focused on specifically testing efficacy and applicability in the Indigenous Australian population.
Interventions
ResApp Health Limited has developed an innovative smartphone-based software application (COPDCheck) to screen adults for COPD. COPDCheck analyzes patient cough sounds together with a few simple questions asked of the patient and instantaneously reports a diagnosis. This will be completed by a research nurse once during the patient visit.
All study procedures are completed within a single visit. As this will be at ED presentation and the standard patient flow and treatment will take priority, th
ResApp Health Limited has developed an innovative smartphone-based software application (COPDCheck) to screen adults for COPD. COPDCheck analyzes patient cough sounds together with a few simple questions asked of the patient and instantaneously reports a diagnosis. This will be completed by a research nurse once during the patient visit. All study procedures are completed within a single visit. As this will be at ED presentation and the standard patient flow and treatment will take priority, the length of the visit is unspecified and will vary per patient. After written informed consent, the COPDCheck Investigational Device (COPDCheck ID) application installed on a study smartphone will be used as follows: 1. Date of birth will be input into the smartphone, 5 voluntary or spontaneous cough sounds which will then be recorded. The study device does not contact the patient and is held by a study team member. 2. History of fever and acute cough, during this illness, and smoking history will be recorded on the study device 3. A standard spirometric assessment will be performed 4. Subject demographic, medical data and clinical diagnosis will be collected in a electronic clinical database. The study team will record the output code from COPDCheck-ID (not a diagnosis, it is an encrypted code) and the clinical team will record a clinical diagnosis. Once the database is locked, the COPDCheck-ID diagnoses will be de-coded and analysis will be performed for PPA and NPA between the COPDCheck-ID diagnosis and the clinical diagnosis. The duration of the study visit will be a maximum of 1 hour.
Sponsors
ResApp Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Must be able to provide written consent. Adults aged 22 years or older, coughing spontaneously or able to cough voluntarily, attending the study site: 1. without known acute or chronic respiratory disease (i) with normal spirometry (termed "healthy patients") or (ii) with spirometry indicating COPD (termed "COPD patients with no previous diagnosis) a. subject must have had a spirometric assessment completed as a result of standard clinical care or be willing to undergo a spirometric assessment OR 2. with a historical diagnosis of COPD and history of smoking or other environmental exposure, or respiratory symptoms consistent with COPD. a. subject must have had a spirometric assessment completed as a result of standard clinical care or be willing to undergo a spirometric assessment Recruitment will occur at GRAMS - Geraldton Regional Aboriginal Medical Service, and as such will include an indigenous population.
Exclusion criteria
1. Lack of consent 2. Patients with asthma and asthma-COPD comorbidity 3. Unable to provide at least 5 coughs sounds recognized by the study device 4. Medical contraindication to voluntary cough, including: o Severe respiratory distress o History of pneumothorax o Eye, chest, or abdominal surgery within the past 3 months 5. Subjects with a clinical diagnosis of Tuberculosis, heart failure, lobectomy, neuromuscular disease or terminal disease 6. Structural airway disease including laryngo/tracheomalacia 7. Mechanical ventilation (invasive, CPAP, or BiPAP) or highflow nasal cannula 8. Too medically unstable to participate in study as per treating clinician
Outcome results
None listed