Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001091291
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
29/06/2018
Date last updated
11/11/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile Health for Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
Evaluation of an innovative mobile health program for the self-management of chronic obstructive pulmonary disease (MH-COPD).
Secondary ID [1] 293398 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MH-COPD
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease. 305543 0
Condition category
Condition code
Respiratory 304776 304776 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
*The intervention is a mobile health platform (application, ‘app’) provided to participants through the Google Play store for their own personal device or provided through an approved mobile device supplied by the researchers.
*Participants will receive 10 educational videos, available at the Lung Foundation Australia website, over the first 5 weeks that range from 6-12 minutes and cover ten topics: 1) Managing your lung disease, 2) How do your lungs work? 3) Managing your breathlessness, 4) Managing treatment options, 5) Questions you can ask your health professional, 6) Who is your healthcare team? 7) Managing your fatigue and energy conservation, 8) Tips for looking after yourself and your condition, 9) Benefits of exercise programs and ongoing support, and 10) Supportive care and end-of-life issues.
*Participants will have access to pre-loaded videos on learning to use inhalers properly, approved by the Lung Foundation Australia.
*Participants will have access to a daily symptom diary to record daily symptoms and exacerbations.
*Participants will have access to an electronic physical activity plan, involving a built-in step counter in the app, which automatically sets incremental goals of increased step counts each week for the first 4 weeks.
*Participants will have access to an electronic version of The Prince Charles Hospital's COPD action plan that will guide symptom and exacerbation control through medications that participants have access to.
*Participants who smoke will have access to an electronic version of the smoking cessation plan that records and aims to reduce the number of cigarettes smoked down to zero after 6 weeks. This is done by gradually reducing the daily smoking goals, by advising the use of smoking cessation plan which includes medications, and through automated, motivational messages (simple encouragement) sent through the app to the mobile phone.
*Participants in the intervention group will be requested to use the app at least once each day.
*All the data entries of the participants recorded via the app, such as symptoms, the action plan, and cigarettes, will be automatically uploaded to the online portal and analysed by research staff to assess the patient adherence. If a participant does not adhere to program for two days, alerts will be generated, and automated motivational messages will be sent to the participant via app notifications. The research staff will review the alerts and accordingly contact the participant to troubleshoot the non-adherence.
*Participants will be provided a 60-minute, face-to-face training session in using the mobile health application (‘app’) by research staff.
Intervention code [1] 301592 0
Lifestyle
Intervention code [2] 301594 0
Treatment: Devices
Intervention code [3] 301595 0
Behaviour
Comparator / control treatment
*Usual care comprised of general written advice about health education, the COPD action plan, symptom monitoring, physical activity, smoking cessation, and inhaler techniques as outlined by the Lung Foundation Australia COPD-X clinical guidelines.
*Participants in the control group will not have access to the mobile health application (app)
*Participants in both groups will be assessed at baseline, 3 months, and 6 months using standardized procedures
Control group
Active

Outcomes
Primary outcome [1] 306392 0
Quality of life assessed through the COPD Assessment Tool (CAT).
Timepoint [1] 306392 0
6 months post-intervention commencement.
Primary outcome [2] 306439 0
Quality of life assessed through the St. George’s Respiratory Questionnaire (SGRQ).
Timepoint [2] 306439 0
6 months post-intervention commencement.
Primary outcome [3] 306440 0
COPD symptoms assessed through the modified MRC (mMRC) dyspnea scale.
Timepoint [3] 306440 0
6 months post-intervention commencement.
Secondary outcome [1] 348323 0
Use of COPD action plan assessed through the self-reported diary, and on the mobile application (interventional group).
Timepoint [1] 348323 0
6 months post-intervention commencement.
Secondary outcome [2] 348324 0
Smoking cessation will be defined as zero cigarettes smoked in the last 7 days of the 6 month follow-up period after commencement of the intervention, as assessed through the self-reported diary.
Timepoint [2] 348324 0
6 months post-intervention commencement.
Secondary outcome [3] 348325 0
Physical activity assessed through the Global Physical Activity Questionnaire (both groups).
Timepoint [3] 348325 0
6 months post-intervention commencement.
Secondary outcome [4] 348326 0
COPD exacerbation rate assessed through the recorded diary (both groups), on the mobile application (interventional group). Exacerbations will be defined as a marked increase in the patient’s baseline dyspnoea, cough and/or sputum that is beyond normal day-to-day variation, that is acute, may warrant a change in the regular medication, or require hospital admission.
Timepoint [4] 348326 0
6 months post-intervention commencement.
Secondary outcome [5] 348327 0
Health care utilization assessed through hospital re-admissions and visits to the emergency department via hospital information systems.
Timepoint [5] 348327 0
6 months post-intervention commencement.
Secondary outcome [6] 348328 0
User experience of the mobile app assessed through a Questionnaire with Likert scales (intervention group) designed specifically for this study.
Timepoint [6] 348328 0
6 months post-intervention commencement.
Secondary outcome [7] 348540 0
Inhaler medicine adherence assessed through the Test of the Adherence to Inhalers (TAI) questionnaire.
Timepoint [7] 348540 0
6 months post-intervention commencement.
Secondary outcome [8] 348541 0
Physical activity assessed through step counts (intervention group) using the mobile phone’s accelerometer.
Timepoint [8] 348541 0
6 months post-intervention commencement.

Eligibility
Key inclusion criteria
*Diagnosis of COPD defined according to the international GOLD guidelines
*Chronic airflow limitation that is not fully reversible (post-bronchodilator FEV1/FVC <70% and FEV1 <80% predicted)
*Current or former smokers with a smoking history of >10 pack-years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Women who are pregnant
*Intellectual or mental impairment
*Other comorbid lung diseases including asthma, active lung cancer, interstitial lung disease, and severe bronchiectasis
*Limitations to the use of mobile technology: non-corrective vision, hearing, cognitive or dexterity impairments that limit the use of technology

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
*Patients from the thoracic outpatient clinic at the hospital will be screened and invited to provide written consent
*Participants will be assigned on a 1:1 basis to the mHealth program for COPD (MH-COPD) or the usual care (UC-COPD) control, with a balanced allocation of males and females
*Randomizations will be printed, concealed in an opaque envelope in a predefined order and stored in a secured cabinet until clinical research staff are ready to reveal the assignment for each participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
*Simple randomization using a computer-generated software package
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
*Analysis will be by intention to treat
*COPD knowledge will assessed at the beginning of intervention through the Lung Foundation Australia questionnaire on COPD knowledge.
*A Chi-Squared Test and ANOVA will be used to compare categorical and continuous variables respectively between the interventional and control groups
*An exponential regression model will be used to predict COPD exacerbations for early interventions
*The sample size has been calculated based on the co-primary outcomes of the CAT score and SGRQ score. 100 patients, randomised 1:1 to intervention (MH-COPD) or usual care (UC-COPD), will have 80% power at significance level (alpha) of 0.05 to detect a clinically important reduction of 3 in the CAT score (primary outcome) in ~50% of intervention patients, compared to 20% in the control group, even with 40 patients in each final group (allowing for up to 20% withdrawal). In addition, this sample size will have 80% power at significance level (alpha) of 0.05 to detect a relative risk of 2 for a clinically important increase in SGRQ of 4 (co-primary outcome) in the intervention group, given a proportion of 30% of the control group achieving this with usual care, even with 40 patients in each final group (allowing for up to 20% withdrawal).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
6/06/2019
Date of last participant enrolment
Anticipated
1/06/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11199 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 23060 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 298024 0
Charities/Societies/Foundations
Name [1] 298024 0
The Prince Charles Hospital Foundation
Country [1] 298024 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Prince Charles Hospital Foundation
Address
627 Rode Road, Chermside, 4032
Queensland
Country
Australia
Secondary sponsor category [1] 297101 0
None
Name [1] 297101 0
Address [1] 297101 0
Country [1] 297101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299057 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 299057 0
Ethics committee country [1] 299057 0
Australia
Date submitted for ethics approval [1] 299057 0
12/04/2018
Approval date [1] 299057 0
08/05/2018
Ethics approval number [1] 299057 0
HREC/16/QPCH/252, SSA/17/QPCH/288

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79138 0
Prof Ian Yang
Address 79138 0
The Prince Charles Hospital
627 Rode Road
Chermside, Postcode 4032
Queensland
Country 79138 0
Australia
Phone 79138 0
+61-7-31395050
Fax 79138 0
+61-7-31394510
Email 79138 0
[email protected]
Contact person for public queries
Name 79139 0
Ian Yang
Address 79139 0
The Prince Charles Hospital
627 Rode Road
Chermside, Postcode 4032
Queensland
Country 79139 0
Australia
Phone 79139 0
+61-7-31395050
Fax 79139 0
+61-7-31394510
Email 79139 0
[email protected]
Contact person for scientific queries
Name 79140 0
Ian Yang
Address 79140 0
The Prince Charles Hospital
627 Rode Road
Chermside, Postcode 4032
Queensland
Country 79140 0
Australia
Phone 79140 0
+61-7-31395050
Fax 79140 0
+61-7-31394510
Email 79140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned for IPD at present


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2434Study protocol https://bmjopen.bmj.com/content/9/4/e025381 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of an innovative mobile health programme for the self-management of chronic obstructive pulmonary disease (MH-COPD): Protocol of a randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-025381
N.B. These documents automatically identified may not have been verified by the study sponsor.