Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000950965
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
23/09/2020
Date last updated
23/09/2020
Date data sharing statement initially provided
23/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the efficacy of an educational program on the tech-savviness of people with chronic obstructive pumonary disease (COPD) - utilising the digital age.
Scientific title
The effect of a practical one-on-one education workshop on the competency and confidence to use the 'Steps' app in people with chronic obstructive pulmonary disease.
Secondary ID [1] 301763 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 318229 0
Condition category
Condition code
Respiratory 316238 316238 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the experimental group will receive practical ‘hands-on’ guidance on how to download a 'Steps app' onto their own smartphone and be able to use the app. The education session will be divided into sub-components of each of the following tasks: 'downloading Steps app', 'opening the Steps app', 'using the Steps app', 'refreshing the screen' and 'closing the app'. During the appointment, the investigator (PhD student) will ask the participant to complete an assessment package, which will comprise a set of predefined tasks, such as downloading the app. Before commencing the assessment package the participant is asked to rate their perceived confidence of completing the task on a 0-10 visual analogue scale. Opening the app, using the app. Refreshing the screen and closing the app. Each task will be broken down into ‘checking for WiFi connection’, ‘connecting to WiFi’, ‘finding the app store’, ‘browsing the app store and locating the Steps app’, and ‘downloading the app’. Once the Steps app is downloaded the participant is required to navigate the app, by registering themselves in the app, locate where the 'step count' is recorded and how to access 'history'of previous days step counts. Participants will be asked to ‘think out aloud’ as they move through the steps required to complete each sub-component. The participant will be permitted to move to the next task only once they meet ‘completion criteria’, defined as; (i) they complete all sub-components of the task correctly or, (ii) they state that they are unable to complete one or more sub-components of the task, despite attempting to do so.
The learning model used for the participants in the experimental group is for acquiring practical skills of ‘show one, do one and teach one’ will be used. This will be approximately 30 minutes of one-on-one education session and there is no time limit on these education sessions. All education sessions will be administered by a the PhD candiate who is an investigator and a physiotherapist.
All sessions will take place at the private room at medical consulting rooms of a Respiratory Consultant who is a co-investigator.
The education session will be developed from data from a previous observation study where different participants will be asked to comment on facilitators and barriers to downloading and using the Steps app.
The participants from control and experimental will take home a Summary of downloading Steps app as a pamphlet and also will be encouraged to record their step amount from the app onto a daily diary given to each participant. The goal of the recording is not about the actual amount of steps done though a record of how often they are engaging with the Steps app.
Intervention code [1] 318059 0
Treatment: Devices
Intervention code [2] 318656 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive standard available COPD patient resources particularly highlighting the way in which Pulmonary Rehabilitation classes assists in improving exercise capacity and reduce symptoms. The content of this session is very unlikely to influence the primary and secondary outcome measures of this study. The education session will be a 30 minute one-on-one education session.
Control group
Placebo

Outcomes
Primary outcome [1] 324427 0
1. The participant will be permitted to move to the next task only once they meet ‘completion criteria’, defined as; (i) they complete all sub-components of the task correctly or, (ii) they state that they are unable to complete one or more sub-components of the task, despite attempting to do so. On completion of each task the PhD student will; (i) record whether or not each sub-component was completed accurately, (ii) record the number of attempts made to complete the sub-component, (iii) record the time it took for the participant to reach completion criteria, (iv) ask the participant to rate their confidence post assessment package with completing task on a 0 – 10 visual analogue scale (VAS).
2. Feasibility of Steps app installation and use will be assessed as the total number of sub-comonents completed accurately across all tasks. task completion was assessed from video recordings of the participants during each assessment.
Timepoint [1] 324427 0
Three time points.
Initial visit Day 1: time point one: Pre-intervention, time point two: post intervention in the same initial 90 minute appointment.
Four weeks later the participant is assessed once more. Second appointment. Primary endpoint three.
Secondary outcome [1] 384607 0
Secondary outcomes will comprise of; (i) total number of attempts made to complete each sub-component for each task, the perception of confidence with each task completion measured using the visual analogue scale (VAS).
This outcome is assessed by observing the participant using a predefined checklist. Video recordings of the participant is also used for fidelity of the assessor as two researchers in the team will independently assess the participant via the video-recordings.
Timepoint [1] 384607 0
Three time points.
Initial visit Day 1: time point one: Pre-intervention, time point two: post intervention in the same initial 90 minute appointment.
Four weeks later the participant is assessed once more. Second appointment. Primary endpoint three.
Secondary outcome [2] 384608 0
Time taken to reach completion criteria for the 'downloading Steps app' task.
The participant will be permitted to move to the next task only once they meet ‘completion criteria’, defined as; (i) they complete all sub-components of the task correctly or, (ii) they state that they are unable to complete one or more sub-components of the task, despite attempting to do so.
This secondary outcome is assessed using video-recording of the participant doing the task and can be timed with a stop watch.
Timepoint [2] 384608 0
Three time points. Before the intervention, post intervention in the same 90 minute appointment. First appointment
One month following the intervention the participant is assessed once more. Second appointment
Three assessments per participant.
Secondary outcome [3] 384609 0
Perception of the particiipant's confidence with each task completion, measured in visual analogue scale (VAS)
Timepoint [3] 384609 0
Four time points. Before the intervention, post intervention in the same 90 minute appointment. First appointment
One month following the intervention the participant is assessed before the assessment and after the assessment. Second appointment
Four assessments per participant.

Eligibility
Key inclusion criteria
Inclusion criteria: People will be eligible to participate in the study if they; (i) have a clinical diagnosis of COPD, (ii) own a smartphone, (iii) report being able to read and write in English. Any participant with a documented history of a cognitive disorder will be excluded.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any participant with a documented history of a cognitive disorder will be excluded or report being unable to read or write in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation and concealment of the randomisation sequence. Group allocation will be decided using a computer-based randomisation sequence. This will be performed by an investigator who is independent of the outcome assessing and performing the education sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be decided using a computer-based randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
For transparency of this study the PhD student’s assessment package video-recording will be reviewed by two independent investigators, the research assistant and lead investigator, they will be blinded to the participant’s group. The review of the participant video-recording of the assessment package will be randomly allocated.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study's sample size calculations: Sample size calculations have been undertaken using earlier work published by Dr Hill. Specifically, this earlier study explored the effect of a brief education program on disease-specific knowledge in people with COPD. In this study, completion of two one-on-one education sessions produced a between difference in disease-specific knowledge measured using the Bristol COPD Knowledge Questionnaire; maximum score = 60 points of 8.3 points (95% confidence interval 5.5 to 11.2). In order to use these data, in the current study, the primary outcome will be the total number of sub-components that were completed accurately, graded on scale with a maximum score of 60. To detect a similar between group difference as seen in the earlier knowledge translation study of 8 sub-components (Hill, 2010) (standard deviation of 7 sub-components, alpha = 0.05, 1- beta = 0.8), a total sample size is required of 26 (13 per group). To account for loss to follow-up, we will aim to recruit a total of 30 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306194 0
University
Name [1] 306194 0
Curtin University of Technology
Country [1] 306194 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 306673 0
None
Name [1] 306673 0
Address [1] 306673 0
Country [1] 306673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306405 0
Joondalup Health Campus human Research Ethics Committee
Ethics committee address [1] 306405 0
Corner of Grand Boulevarde and Shenton Avenue
Joondalup WA 6027
Ethics committee country [1] 306405 0
Australia
Date submitted for ethics approval [1] 306405 0
08/07/2020
Approval date [1] 306405 0
02/09/2020
Ethics approval number [1] 306405 0
Ethics committee name [2] 306412 0
Curtin University
Ethics committee address [2] 306412 0
Kent Street Bentley WA 6027
Ethics committee country [2] 306412 0
Australia
Date submitted for ethics approval [2] 306412 0
17/08/2020
Approval date [2] 306412 0
Ethics approval number [2] 306412 0

Summary
Brief summary
In people with COPD; (i) what are the issues related to downloading and using the Step app and, (ii) what is the effect of a single education session on competency to download and use the Step app.
Methodology: Participants with a diagnosis of COPD own a smartphone and are literate in English.
Participant will be involved in completing three assessments and one education session (over two appointments). During the first 90-minute appointment, all participants will do a 0 – 10 visual analogue scale (VAS) to rate their perceived confidence in completing the tasks, this will be done four times over the two appointments.(before and after the assessment package or tasks.). The assessment package is described below. Thereafter, participants will be randomly allocated to one of two groups; experimental or control. Those in the experimental group will receive a 30 minute one-on-one education session on the use of the smartphone and Step app and those in the control groups will receive a 30-minute one-on-one education session on the nature of COPD and way in which rehabilitation produces benefits. Immediately following completion of the education session, all participants will repeat the assessment package. The PhD student will conduct all the education sessions for the participants.
During the second appointment, conducted one month later, participants will complete a third (and final) administration of the assessment package. This appointment will be approximately one hour in duration.
Assessment package: the PhD student will ask the participant to complete a set of predefined tasks, such as downloading the app, opening the app, using the app, refreshing the screen and closing the app. Each task will be broken down into sub-components. The participant will be permitted to move to the next task only once they meet ‘completion criteria’. On completion of each task the PhD student will; (i) record whether or not each sub-component was completed accurately, (ii) record the number of attempts made to complete the sub-component, (iii) record the time it took for the participant to reach completion criteria, (iv) ask the participant to rate their confidence with completing task on a 0 – 10 visual analogue scale (VAS). This will be video-recorded with only the hands of the participant in the frame with no identifying features.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103770 0
Ms Fiona Coll
Address 103770 0
School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, WA. 6102
Country 103770 0
Australia
Phone 103770 0
+61438927944
Fax 103770 0
Email 103770 0
[email protected]
Contact person for public queries
Name 103771 0
Ms Fiona Coll
Address 103771 0
School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street, WA, 6102
Country 103771 0
Australia
Phone 103771 0
+61438927944
Fax 103771 0
Email 103771 0
[email protected]
Contact person for scientific queries
Name 103772 0
Ms Fiona Coll
Address 103772 0
School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Kent Street WA 6102.
Country 103772 0
Australia
Phone 103772 0
+61438927944
Fax 103772 0
Email 103772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only the primary and secondary outcome data
When will data be available (start and end dates)?
The data is potentially available from study completion August 2021 and no end date
Available to whom?
On request by the wider reasearch community
Available for what types of analyses?
data analysis
How or where can data be obtained?
By contacting the principle investigator: [email protected]


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.