Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000772246
Ethics application status
Approved
Date submitted
4/05/2018
Date registered
8/05/2018
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to test a smartphone app to monitor disability in patients attending hospital for a six minute walk test
Scientific title
An open-source smartphone app to enable accurate, continuous, remote assessment of physical activity and participation in patients attending hospital for a six minute walk test.
Secondary ID [1] 294789 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability 307717 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306770 306770 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are assessing the feasibility and accuracy of using a smartphone app to measure a remote 6 min walk test, to count steps, record GPS data and allow participants to respond to a questionnaire. Participants will install an app on their phone at clinic. They will perform 2 in clinic 6 minute walk tests while using the app. Over a 5 day study period they will perform 3 remote 6 minute walk test and provide a response to the WHO-DAS questionnaire using the app. The smartphone app will extract step counts from before their clinic appointment. During 2 months following the clinic appointment the smartphone app will report their step counts and GPS data wirelessly. These will be used to calculate daily step counts and walking speed. The GPS data will be used to calculate how much time they spend at home, how far they travel, how many destinations they visit and the geographical area they interact with on a daily basis using a convex polygon and standard deviation ellipse activity space.
Intervention code [1] 301104 0
Diagnosis / Prognosis
Comparator / control treatment
The control will be 2 in clinic 6 minute walk tests, a fitbit One pedometer, a BT-Q1000XT GPS transponder and a questionnaire asked in person
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305764 0
To assess the reliability of 6MWT distance recorded by a smartphone app in a remote environment. We will compare the distance walked between the two in clinic tests, calculating lins concordance coefficient and performing Bland-Altman analysis. We will assess for reliability by comparing the three walk tests performed during the 5 day study period
Timepoint [1] 305764 0
over 5 days following clinic appointment
Secondary outcome [1] 346410 0
Mean daily step count assessed by Fitbit One or smartphone app
Timepoint [1] 346410 0
over 5 days following clinic appointment
Secondary outcome [2] 346411 0
GPS position from the smartphone app or dedicated transponder
Timepoint [2] 346411 0
over 5 days following clinic appointment
Secondary outcome [3] 346412 0
Health Status as assessed by WHO DAS 2.0 responses
Timepoint [3] 346412 0
One response from the app during the 5 day study period, following clinic and 1 response asked in person at the end of the study period
Secondary outcome [4] 346414 0
Patient satisfaction with the use of a smartphone app using a locally developed satisfaction questionnaire
Timepoint [4] 346414 0
At the conclusion of the 5 day study period, following their clinic appointment.
Secondary outcome [5] 346415 0
Standard deviation activity space calculated from smartphone GPS data
Timepoint [5] 346415 0
over 2 months following clinic appointment
Secondary outcome [6] 346533 0
Mean daily step counts from smartphone app
Timepoint [6] 346533 0
2 months following clinic appointment.
Secondary outcome [7] 346576 0
time spent at home calculated from smartphone GPS data
Timepoint [7] 346576 0
over 2 months following clinic
Secondary outcome [8] 346577 0
number of destinations visited calculated from smartphone GPS data
Timepoint [8] 346577 0
over 2 months following clinic appointment
Secondary outcome [9] 346578 0
distance traveled calculated from smartphone GPS data
Timepoint [9] 346578 0
over 2 months following clinic appointment calculated from smartphone GPS data
Secondary outcome [10] 346579 0
Minimum convex polygon activity space calculated from smartphone GPS data
Timepoint [10] 346579 0
over 2 months following clinic appointment
Secondary outcome [11] 346580 0
walking speed from the smartphone app
Timepoint [11] 346580 0
over 2 months following clinic appointment

Eligibility
Key inclusion criteria
• Aged > 18 years
• Own a smartphone that has an accelerometer and reports GPS data.
• Consent to installing our app on their phone, and leaving it on their phone for 2 months.
• Perform a 6MWT in clinic with no adverse effects and without the need to stop.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Refusal of consent
• Inability to complete a 6MWT
• Not able to be followed-up at 5 days.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Continuous data will be described by mean (standard deviation) or median [interquartile range] depending upon normality of distribution. Categorical data will be summarized as number (percentage). Between group comparisons will be performed by t-test, rank-sum, or chi-squared distribution of frequencies as indicated.
Where repeated measures exist, population average point estimates and between group comparisons will employ generalized estimating equations.
Concordance between like measures will be assessed by Lin’s concordance correlation statistic and Bland-Altman limits of agreement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10836 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 10837 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 22580 0
5000 - Adelaide
Recruitment postcode(s) [2] 22581 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 299397 0
Hospital
Name [1] 299397 0
Royal Adelaide Hospital
Country [1] 299397 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 298683 0
Hospital
Name [1] 298683 0
Royal Adelaide Hospital
Address [1] 298683 0
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country [1] 298683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300300 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 300300 0
L3,
Roma Mitchell House,
North Terrace,
Adelaide
SA 5000
Ethics committee country [1] 300300 0
Australia
Date submitted for ethics approval [1] 300300 0
12/12/2017
Approval date [1] 300300 0
26/04/2018
Ethics approval number [1] 300300 0
HREC/17/RAH/568

Summary
Brief summary
Our primary objective is to develop an app capable of remotely performing a six-minute walk test (6MWT), reporting step-count data, reporting GPS data, extracting historical, pre-morbid step-data and providing responses to health-related quality of life (HRQoL) assessments, namely the world health organisation’s disability assessment schedule 2.0 (WHO-DAS). Ultimately, we want to perform accurate, objective and repeat sequential assessment of a patient’s physical function and level of activity. In this study, we plan to validate the app (Clinical Health Tracker) in 50 patients who attended hospital for a 6MWT over a subsequent five-day study period. The objectives for this component will be achieved by comparing:-
The distances reported by the smartphone app during two 6MWT’s performed at recruitment, in clinic, with the actual distance walked and with three remotely performed 6MWTs during the study period.
Daily step-counts reported by the app with daily step-counts reported by a Fitbit one.
GPS data from the app with data from a BT-3000X GPS transponder
WHO-DAS responses from the smartphone app with WHO-DAS responses to the questionnaire asked at the end of the study period.
Step-count prior to the smartphone app being installed to step-counts following installation, to assess if the knowledge of being monitored affects the patient’s level of activity.
Smartphone app generated GPS and step-count outcomes over a two month follow-up period
We aim to validate the smartphone app in 50 individuals who are attending hospital for an outpatient 6MWT.

We wish to enrol 50 individuals, 25 iPhone owners and 25 Android phone owners, who have been referred to the 6MWT clinic

All patients who are scheduled to attend a 6MWT within CALHN will be written to, advising them of the study. Following consent, we will complete basic demographic details. participants will install our app on their phone using a local Wi-Fi network. Each individual will be provided with a unique ID in order to activate the app and will be provided with written and verbal instructions to the app’s use. They will be provided with a Fitbit one pedometer and a GPS transponder. They will perform their in-clinic 6MWT with the app recording the distance walked and the Fitbit recording the number of steps taken. They will then perform a second 6MWT, in clinic, using the app. They will leave clinic and undergo a 5-day study period, commencing at midnight the same day. They will be instructed to answer the WHO-DAS questionnaire using the app and to perform 3 remote 6MWT’s during the study period.
Patients will be visited at home, or given the option to return to the Royal Adelaide Hospital, 5 days following their clinic appointment. The pedometer will be retrieved and step-counts extracted. They will provide verbal responses to the WHO-DAS and patient satisfaction questionnaires. Two months after their follow-up visit they will be phoned to remove the Clinical Health Tracker App.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83206 0
Dr Samuel Gluck
Address 83206 0
4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 83206 0
Australia
Phone 83206 0
+61 8 70741758
Fax 83206 0
Email 83206 0
[email protected]
Contact person for public queries
Name 83207 0
Dr Samuel Gluck
Address 83207 0
4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 83207 0
Australia
Phone 83207 0
+61 8 70741758
Fax 83207 0
Email 83207 0
[email protected]
Contact person for scientific queries
Name 83208 0
Dr Samuel Gluck
Address 83208 0
4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 83208 0
Australia
Phone 83208 0
+61 8 70741758
Fax 83208 0
Email 83208 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
This wasn't in our ethics submission


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.