ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Critically Ill Patients

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

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]

Not applicable

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

16/12/2015

Date of last participant enrolment

Anticipated

16/12/2016

Actual

10/08/2016

Date of last data collection

Anticipated

Actual

13/02/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital Research Grant

Address [1]

Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/11/2015

Ethics approval number [1]

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

Dr Samuel Gluck

Address

ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 4624

Fax

s.gluck@doctors.org.uk

Contact person for public queries

Name

Samuel Gluck

Address

ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 4624

Fax

s.gluck@doctors.org.uk

Contact person for scientific queries

Name

Samuel Gluck

Address

ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000

Country

Australia

Phone

+61 8 8222 4624

Fax

s.gluck@doctors.org.uk

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	The use of smartphone-derived location data to evaluate participation following critical illness: A pilot observational cohort study	2021	https://doi.org/10.1016/j.aucc.2021.05.007

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically