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Trial registered on ANZCTR


Registration number
ACTRN12616000427471
Ethics application status
Approved
Date submitted
30/03/2016
Date registered
4/04/2016
Date last updated
15/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility and validity of obtaining pre-morbid activity data in critically ill patients using ‘smart-phone’ technology: a validation study - The PRE PED Study
Scientific title
The feasibility and validity of obtaining pre-morbid activity data in critically ill patients using ‘smart-phone’ technology: a validation study
Secondary ID [1] 288872 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill Patients 298166 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298331 298331 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
This is a feasibility study to determine the ability to obtain data from patients smart phones, looking at data from the 28 days prior to ICU admission. Using information obtained from ICU patients smart phones, pre-hospital mobility will be assessed. This information will be compared to the patients status three and six months post ICU admission using a variety of assessment tools. This study will hopefully provide information about functional outcomes for patients based on pre-ICU status. Patients are admitted into the study after 48hrs admission into ICU and when they are able to give written informed consent which can occur in ICU or following discharge to the ward. Patients will be provided with a Fitbit and given instruction on how to download MOVES prior to the follow up visits at three and six months.
Intervention code [1] 294332 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297803 0
The primary objective of this study is to establish feasibility of retrospectively obtaining pre-morbid pedometer/accelerometer and GPS data from the smart-phones of survivors of critical illness.
Timepoint [1] 297803 0
The initial data collection will occur following consent at which time pre-hospital phone data will be collected (for the 28 days prior to ICU admission). Follow up will occur at three and six months following the initial data assessment.
Secondary outcome [1] 322287 0
The secondary objectives of the study are to validate accelerometer data extracted from a patient’s smart phone when they are recovering from critical illness. This will be achieved by comparison with pedometer data recorded using a fitbit, which we will consider as the ‘gold standard’. Information from the mobile phone app MOVES will also be compared with this data. This data will be collected from 10-28 days prior to the clinic visit.
Timepoint [1] 322287 0
Comparisons will be made at 3 and 6 months following initial assessment of phone data with data measured for 10-28 days prior to the clinic visit.
Secondary outcome [2] 322357 0
Functional assessments will also be performed 3 and 6 months following initial assessment. Measurement tools will include a 6 minute walk test, grip strength and functional questionnaires including the FIM instrument, Katz index, Lawton instrument and WHODAS . This will be used as a comparison with the measured data obtained from the activity data from the smart phone, pedometer and the app MOVES.
Timepoint [2] 322357 0
Comparisons will be made at 3 and 6 months with activity data (from smart phone, pedometer and the app MOVES) measured for 10-28 days prior to the clinic visit.

Eligibility
Key inclusion criteria
(1) Ambulatory at baseline (pre-morbid) (walk for 10 minutes continuously or more)
(2) They received >48 of mechanical ventilation
(3) Aged > 18 years
(4) Own a smart phone that has an accelerometer and reports GPS data.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Elective admission
(2) Refusal of consent
(3) Normal place of residence >50km from Adelaide
(4) Long term inability to mobilise e.g. paraplegia, lower limb amputation, etc
(5) Pregnancy
(6) Inability to speak enough English to allow completion of telephone assessments.
(7) They have cognitive or neurological deficits likely to impact their ability to complete the required assessments.
(8) Expected death within 6 months.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
None as this is purely a feasibility study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5507 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 12991 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293224 0
Hospital
Name [1] 293224 0
Royal Adelaide Hospital Research Grant
Address [1] 293224 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country [1] 293224 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Deane
Address
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 292026 0
None
Name [1] 292026 0
Address [1] 292026 0
Country [1] 292026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294704 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 294704 0
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 294704 0
Australia
Date submitted for ethics approval [1] 294704 0
Approval date [1] 294704 0
05/11/2015
Ethics approval number [1] 294704 0
HREC/15/RAH/236

Summary
Brief summary
While impaired functioning has been shown to substantially influence quality of life for survivors of ICU in numerous studies, these studies are always limited as it has not been possible to objectively quantify patient’s pre-morbid function. This information is crucial as currently we cannot precisely quantify activity levels prior to their critical illness and, therefore, we cannot quantify the change in function for an individual patient. The ability to quantify change in functional ability would be a monumental advancement for researchers in other areas of medicine, but of pivotal importance in our field of critical care as researchers could then quantify the impact of intervention as a change in activity levels for an individual patient.
Functional capacity after critical illness is an important outcome measure. Previously to determine functional capacity, researchers have focused on the six-minute walk test and questionnaires to quantify quality of life (QOL) and physical function. Such measures rely upon surrogates being used to subjectively assess pre-morbid functional capacity. There has never been a pre-morbid objective measurement and pedometers have never been used to assess physical activity following critical illness.
The primary objective of this study is to establish feasibility of retrospectively obtaining pre-morbid pedometer/accelerometer and GPS data from the smart-phones of survivors of critical illness.
The secondary objectives of this study are to validate accelerometer data extracted from a patient’s smart phone when they are recovering from critical illness. This will be achieved by comparison with pedometer data, which we will consider as the ‘gold standard’. In addition we will compare these data with data from a mobile phone app (MOVES) data, six-minute walk test, grip strength and functional assessment scores. These measurements of activity will be compared against measurements of function, i.e. the Functional independence measure (FIM), independent activities of daily living (iADLs), Activities of Daily Living (ADLs), extended Glasgow outcome scale (GOSE), Rivermead mobility index, (RMI) and EuroQoL05D-5L-35. Comparisons will be made at 3 and 6 months
The tertiary objective of the study is to explore whether we can use GPS data extracted from the patient’s phone to construct activity or life space polygons to describe the recovery from critical illness at 3 and 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64750 0
Dr Samuel Gluck
Address 64750 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country 64750 0
Australia
Phone 64750 0
+61 8 8222 4624
Fax 64750 0
Email 64750 0
s.gluck@doctors.org.uk
Contact person for public queries
Name 64751 0
Dr Samuel Gluck
Address 64751 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country 64751 0
Australia
Phone 64751 0
+61 8 8222 4624
Fax 64751 0
Email 64751 0
s.gluck@doctors.org.uk
Contact person for scientific queries
Name 64752 0
Dr Samuel Gluck
Address 64752 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Country 64752 0
Australia
Phone 64752 0
+61 8 8222 4624
Fax 64752 0
Email 64752 0
s.gluck@doctors.org.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary