ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Disability

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]

over 5 days following clinic appointment

Secondary outcome [1]

Mean daily step count assessed by Fitbit One or smartphone app

Timepoint [1]

over 5 days following clinic appointment

Secondary outcome [2]

GPS position from the smartphone app or dedicated transponder

Timepoint [2]

over 5 days following clinic appointment

Secondary outcome [3]

Health Status as assessed by WHO DAS 2.0 responses

Timepoint [3]

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]

Patient satisfaction with the use of a smartphone app using a locally developed satisfaction questionnaire

Timepoint [4]

At the conclusion of the 5 day study period, following their clinic appointment.

Secondary outcome [5]

Standard deviation activity space calculated from smartphone GPS data

Timepoint [5]

over 2 months following clinic appointment

Secondary outcome [6]

Mean daily step counts from smartphone app

Timepoint [6]

2 months following clinic appointment.

Secondary outcome [7]

time spent at home calculated from smartphone GPS data

Timepoint [7]

over 2 months following clinic

Secondary outcome [8]

number of destinations visited calculated from smartphone GPS data

Timepoint [8]

over 2 months following clinic appointment

Secondary outcome [9]

distance traveled calculated from smartphone GPS data

Timepoint [9]

over 2 months following clinic appointment calculated from smartphone GPS data

Secondary outcome [10]

Minimum convex polygon activity space calculated from smartphone GPS data

Timepoint [10]

over 2 months following clinic appointment

Secondary outcome [11]

walking speed from the smartphone app

Timepoint [11]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Hampstead Rehabilitation Centre - Northfield

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5085 - Northfield

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country [1]

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]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

L3, 
Roma Mitchell House, 
North Terrace, 
Adelaide
SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/12/2017

Approval date [1]

26/04/2018

Ethics approval number [1]

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

Dr Samuel Gluck

Address

4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741758

Fax

samuel.gluck@sa.gov.au

Contact person for public queries

Name

Samuel Gluck

Address

4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741758

Fax

samuel.gluck@sa.gov.au

Contact person for scientific queries

Name

Samuel Gluck

Address

4G751 AM
ICU Research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61 8 70741758

Fax

samuel.gluck@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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