Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000681459
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
25/05/2016
Date last updated
28/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Next generation assessments of physical function in intensive care unit survivors - validity of two Fitbit tracking devices and smartphone apps
Scientific title
Next generation assessments of physical function in intensive care unit survivors -Validity of two FitBit activity tracking devices and smart phone apps
Secondary ID [1] 288982 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 298380 0
Physical function 298381 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298484 298484 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the outpatient department of the hospital, participants will be provided with a smartphone application (Health App - with the smartphone worn in a pocket) and two wearable devices (Fitbit One worn clipped to the waistband and Fitbit Flex worn on the wrist). They will complete the gold standard battery of physical function tests for approximately 30 minutes as well as conduct a 10 minute treadmill walk while wearing the devices, including the smartphone. The participants will be asked to wear the devices and to carry the smartphone for a 7-day period for as much of the 24 hours as possible in their usual living accommodations. After Day 7, they will undergo a twenty minute telephone assessment of physical function, relay the data from the smartphone applications and be prompted to return the wearable devices via the pre-paid envelope.
Intervention code [1] 294681 0
Other interventions
Comparator / control treatment
The gold standard tests include:

1. Step count - counted directly on a treadmill by the research assistant
2. Functional Independence Measure (FIM)
3. Six minute walk test
4. Grip strength
Control group
Active

Outcomes
Primary outcome [1] 297970 0
Concurrent validity of the three devices (Smartphone application; "Fitbit One" waist accelerometer; "Fitbit Flex" wrist accelerometer) as assessed by 95% limits of agreement between the device step counts and directly counted steps during the treadmill walk test.
Timepoint [1] 297970 0
Baseline (3 or 6 months post ICU admission)
Primary outcome [2] 297973 0
Concurrent validity of the three devices (smartphone application; "Fitbit One" waist accelerometer; "Fitbit Flex" wrist accelerometer) as assessed by 95% limits of agreement between the device step counts and "Gold Standard" measurements of physical function the Functional Independence Measure (FIM), and two additional measures of physical function - the six minute walk test and grip strength.
Timepoint [2] 297973 0
1 week post baseline assessment
Primary outcome [3] 297974 0
Concurrent validity of the telephone assessment as assessed by 95% limits of agreement between the three instruments (Extended Glasgow Coma Scale (GOS-E); Rivermead Mobility Index (RMI); EuroQol-5D-5L, WHODAS) and the three "Gold Standard" measurements of physical function (Functional Independence Measure (FIM), 6 minute walk test, Grip strength).
Timepoint [3] 297974 0
1 week post baseline assessment
Secondary outcome [1] 322804 0
Fraction of patients on which the device was worn for at least 16 hours per day for both the Fitbit one and the Fitbit flex.
Timepoint [1] 322804 0
1 week post baseline

Eligibility
Key inclusion criteria
Participants who were previously admitted to the Intensive Care Unit (ICU) and mechanically ventilated for at least 48 hours and who:
1. report being able to walk continuously for at least 10 minutes prior to ICU admission
2. own a smartphone
3. live within 40km of the recruiting hospital
4. admitted to ICU in the previous 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The ICU-requiring injury prevents post-discharge ambulation (e.g. traumatic lower limb amputation)
2. Inadequate English spoken to enable completion of assessments
3. Pregnancy
4. Severe cognitive or neurological deficits likely to impact the ability to complete assessments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
There is no universally accepted standard as to how precise the 95% CI for the limits of agreement need to be in order to be clinically useful. The sample size of 60 is based on our interpretation of the clinical literature regarding acceptably precise measurement, at feasible cost, as well as having at least as great precision as those published.

Descriptive statistics will be used to describe observations and frequency data and analysed according to normality of distribution (tested via Kolmogorov-Smirnov test) with subsequent parametric or non-parametric equivalent tests chosen as appropriate.
Concurrent validity will be tested for each of the three devices, using a Bland-Altman plot to calculate the 95% limits of agreement between device step counts and the gold standard of directly counted steps (i.e. Smartphone app vs. direct step count; Fitbit One vs. direct step count and Fitbit Flex vs. direct step count). The device that has the smallest 95% limits of agreement will demonstrate the best concurrent validity of the three.
Concurrent validity will be tested for each of the three devices and each gold standard measure, using a Bland-Altman plot to calculate the 95% limits of agreement (i.e. nine Bland-Altman plots: Smartphone app vs FIM; Fitbit One vs FIM and Fitbit Flex vs FIM; repeated for 6MWT and grip strength respectively). The limits of agreement will be compared across the three gold standard tests to analyse whether step count can replace measurement of any of these outcomes in clinical trials; they will also be visually inspected for evidence of floor or ceiling effects.
Concurrent validity will be tested for each telephone assessment and each gold standard measure, using a Bland-Altman plot to calculate the 95% limits of agreement (i.e. nine Bland-Altman plots: FIM vs. GOSE; FIM vs. EQ-5D; FIM vs. Rivermead Mobility Index; repeated for 6MWT and grip strength respectively). The limits of agreement will be compared across the three gold standard tests to analyze whether the telephone measures can replace measurement of any of these outcomes in clinical trials.
Chi-square statistics will be used to assess for pairwise differences between the devices.
We will also include scatter plots as physical function is a complex variable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2016
Actual
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5594 0
The Alfred - Prahran
Recruitment hospital [2] 5598 0
Footscray Hospital - Footscray
Recruitment hospital [3] 5599 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 13045 0
3004 - Melbourne
Recruitment postcode(s) [2] 13046 0
3011 - Footscray
Recruitment postcode(s) [3] 13049 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 293341 0
Charities/Societies/Foundations
Name [1] 293341 0
Intensive Care Foundation
Country [1] 293341 0
Australia
Primary sponsor type
University
Name
Australia and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University
Address
The Alfred Centre
Level 6
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292160 0
None
Name [1] 292160 0
Address [1] 292160 0
Country [1] 292160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294857 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 294857 0
Office of Ethics and Research Governance
Ground Floor, Linay Pavilion
Alfred Hospital
55 Commercial Road
Melbourne
VICTORIA 3004
Ethics committee country [1] 294857 0
Australia
Date submitted for ethics approval [1] 294857 0
25/02/2016
Approval date [1] 294857 0
06/04/2016
Ethics approval number [1] 294857 0
HREC/16/Alfred/10 (Local Reference: Project 57/16)
Ethics committee name [2] 294858 0
Western Health Low Risk Human Research Ethics Panel
Ethics committee address [2] 294858 0
Office for Research
3rd Floor,
Western Centre for Health Research and Education
Sunshine Hospital
Furlong Rd.
St Albans VIC 3021
Ethics committee country [2] 294858 0
Australia
Date submitted for ethics approval [2] 294858 0
Approval date [2] 294858 0
07/01/2016
Ethics approval number [2] 294858 0
LNR/15/WH/205

Summary
Brief summary
This project will compare two "next generation" methods of measurement of physical function to the accepted gold standard assessment of physical function: in-person
testing using validated physical function outcome measures.
We will measure physical activity using (1) wearable devices and smartphone applications and (2) a telephone assessment of global function; we will compare these convenient at home assessments to the gold standard in-person assessments in order to quantify the validity and feasibility of these new approaches to inform future clinical trial design.
The results will be used both within Australia and New Zealand, and internationally, to design future RCTs aiming to measure post discharge and long term physical function outcomes. Moreover, our results will also inform the design of new in-home monitoring strategies for post-ICU clinics and interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65122 0
Dr Carol Hodgson
Address 65122 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65122 0
Australia
Phone 65122 0
+61, 3, 9903 0598
Fax 65122 0
Email 65122 0
[email protected]
Contact person for public queries
Name 65123 0
Dr Carol Hodgson
Address 65123 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65123 0
Australia
Phone 65123 0
+61, 3, 9903 0598
Fax 65123 0
Email 65123 0
[email protected]
Contact person for scientific queries
Name 65124 0
Dr Carol Hodgson
Address 65124 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 65124 0
Australia
Phone 65124 0
+61, 3, 9903 0598
Fax 65124 0
Email 65124 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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