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Trial registered on ANZCTR


Registration number
ACTRN12620000144910
Ethics application status
Approved
Date submitted
22/01/2020
Date registered
12/02/2020
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study using Non-Contact Smartphone Cough Sound Recordings to Screen
for Chronic Obstructive Pulmonary Disease in an Indigenous Australian Adult
Population
Scientific title
A Pilot Study using Non-Contact Smartphone Cough Sound Recordings to Screen
for Chronic Obstructive Pulmonary Disease in an Indigenous Australian Adult
Population.
Secondary ID [1] 300215 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COPDCheck
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 315776 0
Condition category
Condition code
Respiratory 314061 314061 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316490 0
Diagnosis / Prognosis
Comparator / control treatment
COPDCheck diagnoses will be compared to standard-of-care clinical diagnosis. COPD is confirmed by spirometry.
Control group
Active

Outcomes
Primary outcome [1] 322457 0
Composite primary outcome of positive percent agreement (PPA) and negative percent agreement (NPA) of the COPDCheck algorithms to diagnose and rule out chronic obstructive pulmonary disease (COPD).

Further detail on primary outcome:
The data will be evaluated by PPA, NPA, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-). The data will be evaluated by comparing the performance to previous studies and literature.
Timepoint [1] 322457 0
End of Study (when all participant data has been collected).
Secondary outcome [1] 378602 0
Nil
Timepoint [1] 378602 0
Nil

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Positive percent agreement (PPA; i.e., sensitivity) and negative percent agreement (NPA; i.e., specificity) of given diagnoses will be computed against the clinical reference diagnosis. The data will be evaluated by PPA, NPA, positive predictive value (PPV), negative predictive value
(NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 28989 0
6530 - Rangeway

Funding & Sponsors
Funding source category [1] 304647 0
Commercial sector/Industry
Name [1] 304647 0
ResApp Health
Address [1] 304647 0
Level 12, 100 Creek Street, Brisbane, QLD, 4000
Country [1] 304647 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResApp Health
Address
Level 12, 100 Creek Street, Brisbane, QLD, 4000
Country
Australia
Secondary sponsor category [1] 304947 0
None
Name [1] 304947 0
Address [1] 304947 0
Country [1] 304947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305068 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 305068 0
450 Beaufort Street, Highgate WA 6003
Ethics committee country [1] 305068 0
Australia
Date submitted for ethics approval [1] 305068 0
13/11/2019
Approval date [1] 305068 0
09/12/2019
Ethics approval number [1] 305068 0
HREC 953

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99158 0
Dr Scott Claxton
Address 99158 0
Specialist Medical Centre (West), Joondalup Health Campus, 103 Shenton Ave, Joondalup WA 6027
Country 99158 0
Australia
Phone 99158 0
+61 8 9233 5200
Fax 99158 0
Email 99158 0
clinicalstudies@resapphealth.com.au
Contact person for public queries
Name 99159 0
Ms Neroli Anderson
Address 99159 0
ResApp Health Limited, Level 12, 100 Creek Street, Brisbane, QLD, 4000
Country 99159 0
Australia
Phone 99159 0
+61 7 3724 0035
Fax 99159 0
Email 99159 0
clinicalstudies@resapphealth.com.au
Contact person for scientific queries
Name 99160 0
Ms Kate Lingard
Address 99160 0
ResApp Health Limited, Level 12, 100 Creek Street, Brisbane, QLD, 4000
Country 99160 0
Australia
Phone 99160 0
+61 7 3724 0035
Fax 99160 0
Email 99160 0
clinicalstudies@resapphealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study will be reported via scientific paper at the conclusion of the study. It is not likely that IPDs will be required to be produced within the statistical outputs in order to publish the paper.
What supporting documents are/will be available?
No other documents available
Summary results
No Results