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Trial registered on ANZCTR


Registration number
ACTRN12617000941369
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
30/06/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Response to SmartInhaler triggered flare up alert for management of Chronic Obstructive Pulmonary Disease in the Sensing City.
Scientific title
Can a localised response to a SmartInhaler triggered alert improve management of Chronic Obstructive Pulmonary Disease, by decreasing unplanned healthcare utilisation in the Sensing City.
Secondary ID [1] 292244 0
Nil Known
Universal Trial Number (UTN)
U1111-1198-1801
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 303746 0
Condition category
Condition code
Respiratory 303119 303119 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be trialled is a response to the alert triggered by the exacerbation risk prediction algorithm resulting from Bayesian network analysis of reliever inhaler use (collected by Adherium smartInhalers), and baseline health data. The refinements to the sensitivity and specificity of the alert will occur during the initial phase of this study which is anticipated to take 6 months. The response will be trialled over a 12 month period. Depending on the sensitivity of the alert the response will occur within 24hrs of the trigger. The response will be a phone call by the practice nurse from the patient’s general practice, supported by a view of the patient’s electronic medical record, to assess the patient’s situation and any concerns. The number of time the intervention (response to alert) will be delivered depends on the alert trigger frequency, and will initially be phone contact, however if felt appropriate, a subsequent direct patient contact, usually in the patient’s general practice (during office hours), or in the 24 hour surgery out of hours will be arranged.
Intervention code [1] 298404 0
Treatment: Other
Intervention code [2] 298405 0
Treatment: Devices
Comparator / control treatment
NO control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302497 0
The primary outcome measure will be a comparison of the cost of planned and unplanned healthcare. The costs of events such as GP visits, ambulance call outs, admissions to hospital, afterhours surgery visits etc will be collated from available health care resources (planning and funding CDHB, MoH, Primary healthcare organisations). participants in the study will be asked about their use of healthcare during their flare ups, confirmation will be gathered from medical records, including GP and hospital sources.
Timepoint [1] 302497 0
The costs of each participants planned and unplanned healthcare will be assessed at the end of the study, ie 12 months after the intervention goes live.
Secondary outcome [1] 336227 0
Secondary outcome measures planned and unplanned healthcare use, determined by searching participants medical records.
Timepoint [1] 336227 0
This will be assessed at the end of the study, ie 12 months after the intervention goes live.
Secondary outcome [2] 336309 0
Exacerbation frequency determined from patient reported exacerbation and medical records.
Timepoint [2] 336309 0
Assessed at end of study (12months)
Secondary outcome [3] 336310 0
Health related quality of life, measured using HADS and EQ5D
Timepoint [3] 336310 0
Questionnaires completed at baseline and after 12 months intervention.

Eligibility
Key inclusion criteria
Enrolled at participating practice
Smoking-related chronic obstructive pulmonary disease (COPD)
Able and willing to provide written informed consent to participate.
Currently prescribed and using metered dose inhalers (MDI) for reliever medication (Duolin, Respigen, Ventolin)
Two or more exacerbations requiring antibiotics in the last 12 months OR
Admitted to hospital with exacerbation or COPD related illness in the last 3 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant medical co-morbidity which, in the opinion of the investigators, would significantly impact on their ability to participate in the study.
In hospital level care facilities.
Significant cognitive impairment.
Living outside Canterbury or has plans to move in next 6 months.
Unable or unwilling to use study devices, including requires haleraid to use MDI
Participation in other research studies that would interfere with this one.

Study design
Purpose of the study
Treatment
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)
N/A
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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 outside Australia
Country [1] 9006 0
New Zealand
State/province [1] 9006 0
Christchurch

Funding & Sponsors
Funding source category [1] 296792 0
Hospital
Name [1] 296792 0
Canterbury District Health Board
Address [1] 296792 0
Respiratory Research Group
Respiratory Services
Private Bag 4710
Christchurch
8140
Country [1] 296792 0
New Zealand
Primary sponsor type
Hospital
Name
Canterbury District Health Board
Address
Respiratory Research Group
Respiratory Services
Private Bag 4710
Christchurch
8140
Country
New Zealand
Secondary sponsor category [1] 295776 0
None
Name [1] 295776 0
Address [1] 295776 0
Country [1] 295776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298026 0
Health and Disability Ethics Committee
Ethics committee address [1] 298026 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298026 0
New Zealand
Date submitted for ethics approval [1] 298026 0
21/07/2017
Approval date [1] 298026 0
07/08/2017
Ethics approval number [1] 298026 0
17/STH/120

Summary
Brief summary
COPD (Chronic Obstructive Pulmonary Disease) is a chronic lung disease, usually caused by cigarette smoking, which leads to gradual worsening breathlessness and cough. People with COPD can experience frequent flare-ups (exacerbations) of their condition. These flare ups usually require significant and increasing health-care attention, and often hospital admission. Unfortunately some people with COPD delay seeking medical attention for their flare ups and this causes the condition to worsen and then an ambulance is called.
The group of researchers involved in this project have previously used automated monitoring of reliever inhaler use by people with COPD to determine if their health is worsening and predict their likely risk of a flare up. This has led to the development of an exacerbation alert. We now want to establish a response to this alert to help people with COPD manage their flare ups early. This response will be individualised and delivered by the patients general practice team.
We will measure the cost of this response and determine if it decreases unplanned trips to hospital, and also if patients quality of life is improved by this exacerbation management strategy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75738 0
Dr Michael Epton
Address 75738 0
Canterbury Respiratory Research Group
Respiratory Services
Christchurch Hospital
Private Bag 4710
Christchurch
8140
Country 75738 0
New Zealand
Phone 75738 0
+64 3 364 1157
Fax 75738 0
Email 75738 0
michael.epton@cdhb.health.nz
Contact person for public queries
Name 75739 0
Dr Malina Storer
Address 75739 0
Canterbury Respiratory Research Group
Respiratory Services
Christchurch Hospital
Private Bag 4710
Christchurch
8140
Country 75739 0
New Zealand
Phone 75739 0
+64 3 364 1157
Fax 75739 0
Email 75739 0
malina.storer@cdhb.health.nz
Contact person for scientific queries
Name 75740 0
Dr Malina Storer
Address 75740 0
Canterbury Respiratory Research Group
Respiratory Services
Christchurch Hospital
Private Bag 4710
Christchurch
8140
Country 75740 0
New Zealand
Phone 75740 0
+ 64 3 364 1157
Fax 75740 0
Email 75740 0
malina.storer@cdhb.health.nz

No data has been provided for results reporting
Summary results
Not applicable