Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000552886
Ethics application status
Approved
Date submitted
16/03/2021
Date registered
12/05/2021
Date last updated
12/05/2021
Date data sharing statement initially provided
12/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ambulatory monitoring and management of chronic obstructive pulmonary disease
Scientific title
Feasibility assessment of an ambulatory monitoring and management of chronic obstructive pulmonary disease
Secondary ID [1] 303705 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SPHERE COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 321124 0
COPD 321125 0
Condition category
Condition code
Respiratory 318918 318918 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient-operated smartphone application with a bluetooth-tethered fingertip pulse oximeter and peak flow meter. Patients will be trained on the operation of the devices and instructed to take once-daily measurements and answer a brief study-specific questionnaire for approximately 5 minutes per day for 14 weeks.

The data will be reviewed each day by a physician for early identification of acute worsening of patient condition. Upon identification of a potential episode of acute worsening of the patient condition a study physician will contact the patient via nominated phone number and discuss their condition and instruct them to follow/escalate to a new stage of their pre-designed COPD action plan (Lung Foundation Australia format) personalised to the patient for this study.

Adherence will be monitored via the physician and assessed via the frequency of data recorded.
Intervention code [1] 320007 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326856 0
Unstructured qualitative feedback via study-specific questionnaire. Participants will be prompted in free-text fields to discuss the perceived benefits and disadvantages of the platform and provide advice on improving acceptance, usability and engagement.
Timepoint [1] 326856 0
14 weeks
Primary outcome [2] 326857 0
Exit questionnaire score via study-specific questionnaire. Areas assessed include acceptance, usability, engagement and perceived benefits of use.
Timepoint [2] 326857 0
14 weeks
Secondary outcome [1] 392889 0
Change in FEV1 from median established in the first 2 weeks of system operation, as measured by the peak flow meter provided to the patient
Timepoint [1] 392889 0
Assessed daily for the first 2 weeks to establish median value, with the median value compared with the final values recorded at Week 14
Secondary outcome [2] 392890 0
Change in PEF from median established in the first 2 weeks of system operation, as measured by the peak flow meter provided to the patient
Timepoint [2] 392890 0
Assessed daily for the first 2 weeks to establish median value, with the median value compared with the final values recorded at Week 14
Secondary outcome [3] 392891 0
Change in SpO2 from median established in the first 2 weeks of system operation, as measured by the pulse oximeter provided to the patient
Timepoint [3] 392891 0
Assessed daily for the first 2 weeks to establish median value, with the median value compared with the final values recorded at Week 14
Secondary outcome [4] 392894 0
Number of true exacerbations as detected by the system and physician reviewing incoming data, and confirmed by site investigators/patient.
Timepoint [4] 392894 0
Week 14
Secondary outcome [5] 392895 0
Number of false exacerbations detected , as measured by the pulse oximeter provided to the patient, and confirmed by site investigators/patient.
Timepoint [5] 392895 0
Week 14
Secondary outcome [6] 392896 0
Number of undetected exacerbations reported by participants or their nominated GP and/or Specialist
Timepoint [6] 392896 0
Week 14
Secondary outcome [7] 392897 0
Change in the CAT score - a validated measure of patient-reported impact of COPD on their life.
Timepoint [7] 392897 0
The change in CAT score will be assessed between the values at baseline and Week 14 only
Secondary outcome [8] 392898 0
Adherence as measured by days without participant-initiated measurement, as automatically detected and reported by the smartphone application.
Timepoint [8] 392898 0
Week 14

Eligibility
Key inclusion criteria
1. Evidence of spirometrically confirmed airflow obstruction, defined as a post-bronchodilator FEV1/FVC ratio <0.7 and post-bronchodilator FEV1 between 30% and 70% predicted, recorded within 1 year of screening

2. Report one or more of the following symptoms within the preceding two weeks: shortness of breath, chronic cough and sputum

3. Hospitalisation for worsening COPD (exacerbation) on one or more occasions in the two years prior to commencement of study procedures

4. Be ambulatory and self-caring at the time of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have experienced an exacerbation in the 30 days prior to screening

2. In the opinion of the investigator will not complete the study or adhere to the intervention

3. In the opinion of the investigator, have an inadequate mastery of English to communicate with study staff

4. Is unable to independently provide consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2021
Actual
Date of last participant enrolment
Anticipated
27/09/2021
Actual
Date of last data collection
Anticipated
3/01/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18933 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 33437 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 308119 0
Other Collaborative groups
Name [1] 308119 0
Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
Country [1] 308119 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
5/1 King St
Newtown, NSW 2042
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 308875 0
None
Name [1] 308875 0
Address [1] 308875 0
Country [1] 308875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308105 0
SWSLHD HREC
Ethics committee address [1] 308105 0
Research Directorate
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871
Ethics committee country [1] 308105 0
Australia
Date submitted for ethics approval [1] 308105 0
Approval date [1] 308105 0
29/11/2018
Ethics approval number [1] 308105 0

Summary
Brief summary
Prior to the COVID-19 pandemic there was growing recognition that at-home health monitoring programs based on a digital technologies could be used to empower community-based COPD patients to independently monitor their symptoms and act on rapid declines in health status.

The 'SPHERE COPD' study is an early pilot study aims to test the feasibility and user-friendliness of a newly developed portable and patient-operated disease monitoring system in a community setting, Centered around a novel smartphone application ("app"), patients can take daily measurements of their lung function, oxygen levels in their blood and track their symptoms and rescue medication use. the app will summarise the data for the participant and securely transmit it to a server for interpretation by a healthcare professional. Deteriorations in participant condition potentially indicative of an exacerbation may be identified by the healthcare professional and queried via a telephone call.

The downstream implications this study to completion are broad but have the potential to alter current approaches to COPD in the community. It may empower the individual to proactively identify an exacerbation and seek early medical assistance. It may also enhance their care by s providing physicians to access to longitudinal data on their patient’s condition between visits provides a powerful new tool with which they can more accurately tailor pharmacotherapies and written COPD action plans to optimise long-term outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109554 0
Prof Christine Jenkins
Address 109554 0
The George Institute for Global Health
5/1 King St
Newtown, NSW 2042
AUSTRALIA
Country 109554 0
Australia
Phone 109554 0
+61 2 8052 4465
Fax 109554 0
Email 109554 0
cjenkins@georgeinstitute.org.au
Contact person for public queries
Name 109555 0
Mr Thomas Bradbury
Address 109555 0
The George Institute for Global Health
5/1 King St
Newtown, NSW 2042
AUSTRALIA
Country 109555 0
Australia
Phone 109555 0
+61 2 8052 4413
Fax 109555 0
Email 109555 0
tbradbury@unsw.edu.au
Contact person for scientific queries
Name 109556 0
Mr Thomas Bradbury
Address 109556 0
The George Institute for Global Health
5/1 King St
Newtown, NSW 2042
AUSTRALIA
Country 109556 0
Australia
Phone 109556 0
+61 2 8052 4413
Fax 109556 0
Email 109556 0
tbradbury@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive and personal health information will be contained in individual participant data. At this time it is planned that only summaries of the de-identified data will be available.


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
No additional documents have been identified.