ANZCTR - Registration

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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

10/10/2022

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]

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)

Condition category

Condition code

Respiratory

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]

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]

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]

End of Study (when all participant data has been collected).

Secondary outcome [1]

Nil

Timepoint [1]

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

Sex

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

Recruiting

Date of first participant enrolment

Anticipated

9/07/2021

Actual

9/07/2021

Date of last participant enrolment

Anticipated

30/06/2023

Actual

Date of last data collection

Anticipated

30/06/2023

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6530 - Rangeway

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

ResApp Health

Address [1]

Level 12, 100 Creek Street, Brisbane, QLD, 4000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Australian Aboriginal Health Ethics Committee

Ethics committee address [1]

450 Beaufort Street, Highgate WA 6003

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/11/2019

Approval date [1]

09/12/2019

Ethics approval number [1]

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

Dr Scott Claxton

Address

Specialist Medical Centre (West), Joondalup Health Campus, 103 Shenton Ave, Joondalup WA 6027

Country

Australia

Phone

+61 8 9233 5200

Fax

clinicalstudies@resapphealth.com.au

Contact person for public queries

Name

Neroli Anderson

Address

ResApp Health Limited, Level 12, 100 Creek Street, Brisbane, QLD, 4000

Country

Australia

Phone

+61 7 3724 0035

Fax

clinicalstudies@resapphealth.com.au

Contact person for scientific queries

Name

Neroli Anderson

Address

ResApp Health Limited, Level 12, 100 Creek Street, Brisbane, QLD, 4000

Country

Australia

Phone

+61 7 3724 0035

Fax

clinicalstudies@resapphealth.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Implementation of a novel digital diagnostic tool to support the assessment of respiratory disease in a COVID-19 fever clinic	2022	https://doi.org/10.1136/bmjinnov-2021-000673

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically