ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001498189p

Ethics application status

Submitted, not yet approved

Date submitted

20/09/2019

Date registered

30/10/2019

Date last updated

30/10/2019

Date data sharing statement initially provided

30/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The feasibility of a smartphone app to follow up survivors of Intensive Care Unit admission – SMART - ICU

Scientific title

The feasibility of a smartphone app to follow up survivors of Intensive Care Unit admission

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

SMART - ICU

Linked study record

Health condition

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

Critically Ill Patients

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a pilot study to assess the ability of smart phones to gather functional data on patients discharged from ICU following an admission of greater than 48 hours. An electronic medical record system will allow selection of prospective participants that meet the inclusion criteria and they will be contacted 1 month after hospital discharge by paper letter. They will be asked for consent and to install a smart phone app called the Patient Outcomes Measure (POM) that will monitor their movements and track their daily step count and the distance they travel each day for a total of 6 months The only device they will need to carry with them will be their phone and it will only monitor the participant if it is carried with them. They will also be contacted at 3 and 6 months to complete conventional surveys aimed at assessing key aspects of general health to compare to their smart phone data. The surveys should take from 30-45 minutes to complete.

Intervention code [1]

Not applicable

Comparator / control treatment

The study group will be compared to a control group consisting of the same inclusion criteria, i.e. greater than 48 hour admission to ICU, contacted the same way, by paper letter 1 month post hospital discharge but these individuals will not utilise their smart phones to collect daily step and travel data. They will be contacted at 3 and 6 months to report their general health by conventional survey methods only.

Control group

Active

Outcomes

Primary outcome [1]

To describe the number of successful app activations as assessed by a remote app data monitoring database, as a means of exploring if this method of data collection is feasible by patients being discharged from ICU

Timepoint [1]

Data will be collected remotely by an app monitoring database for 6 months where upon the trial period will cease and participants will be contacted to thank them for their involvement. Those with apps on their phones will be requested to delete the app. Follow up with conventional questionnaires will occur at 3 and 6 months post recruitment

Primary outcome [2]

To describe steps per day data for each patient with an activated POM app as measured by the POM app and collected and stored by remote app monitoring database.

Timepoint [2]

Primary outcome [3]

To describe distance-travelled per day data of participants with activated POM apps as measured by the POM app and stored on a remote app monitoring database

Timepoint [3]

Secondary outcome [1]

Assess quality of life using the European Quality of Life Assessment of 5 Domains (EQ-5D) in both the smart phone and non smart phone groups.

Timepoint [1]

Data will be collected by participants' preferred method (phone call, email or paper-mail) at 3 and 6 months where upon participants will be thanked for their time. Those with the app will be asked to delete it.

Secondary outcome [2]

To assess post traumatic stress in ICU survivors using and Impact of Events Scale; Revised (IES-R) in both the smart phone and non smart phone groups

Timepoint [2]

Secondary outcome [3]

Assess level of function utilising the World Health Organisation Disability Assessment Scale (WHODAS 2.0) in both the smart phone and non smart phone groups.

Timepoint [3]

Secondary outcome [4]

To assess depression of ICU survivors using Hospital Anxiety Depression Scale (HADS) in both the smart phone and non smart phone groups

Timepoint [4]

Eligibility

Key inclusion criteria

• Emergency admission to ICU
• ICU length of stay (LoS) equal to or greater than 48 hrs
• Age equal to or greater than 18 years

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Readmitted to ICU
• Non-English speaker

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Summative data will be presented a n (%), mean (SD) or median [IQR] depending on normality. Between group comparisons will be calculated with student t-tests or fisher exact test as appropriate.

GPS data outcomes
.1 – Time spent at home – Calculated by finding the location where the 7 longest period of inactivity took place over the last 7 days. This data is run through a clustering algorithm, the modal cluster (cluster with most points) is used to define the home nodal point, by averaging the latitude and longitude of the points in the modal cluster. The amount of time spent within 100m of this nodal point is calculated per 24 hr period and expressed as a percentage of total time in 24 hrs.
.2 – Number of locations visited – The Spatial-Temporal Density-Based Spatial Clustering of Applications with Noise (ST-DBSCAN), allows for clusters to be defined as the number of sequential GPS positions, within a pre-specified distance from the last point. We defined this a 3-points (15 minutes) with 100 m of the last point. The number of clusters or locations visited per 24 hours was recorded.
.3 – Linear distance travelled – The distance between each GPS point was measured and summed over a 24-hour period. In addition, to overcome the coastline paradox, where by the distance travelled increases with shortening GPS epoch, the distance between locations visited will also be calculated.
.4 – Minimum Convex Polygon Activity Space – A minimum convex polygon activity space is the area of a polygon that bounds the GPS locations, such that no internal angle of the polygon is greater than 180o.
.5 – Standard Deviation Ellipse Activity Space – A standard deviation ellipse is the area of an ellipse plotted from the mean longitude and latitude where the short access is formed by minimum standard deviation in longitude and latitude and the long axis is calculated by the maximum standard deviation in longitude and latitude.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/11/2019

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

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

Address [1]

Port Road
Adelaide
SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

Royal Adelaide Hospital
Port Road
Adelaide
SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)

Ethics committee address [1]

L3, Roma Mitchell House, North Terrace, Adelaide – Postal Details: RAH Clinical Trial Centre, Wayfinder 3D460.02, Level 3, Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/08/2019

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Smart phone technology may offer an opportunity to collect data on patient outcomes following ICU admission and discharge so as to better future researchers. Using apps installed on a smart phone patient markers of patient function can be remotely monitored and automatically collated without the need for inconvenient time consuming questionnaires or clinic follow ups. The Patient Outcomes Measure app can collect such data as effectively as conventional validated historical questionnaire methods.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Edward de'Lisle-Tarr

Address

ICU research
Royal Adelaide Hospital
ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61451224261

Fax

[email protected]

Contact person for public queries

Name

Edward de'Lisle-Tarr

Address

ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61451224261

Fax

[email protected]

Contact person for scientific queries

Name

Edward de'Lisle-Tarr

Address

ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000

Country

Australia

Phone

+61451224261

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

Published available data will be de-identified for security and privacy purposes. However prior to publication data will be able to be identified so that deletion of accrued data can be enacted in the event a participant wishes to drop out of the study and have their data destroyed. This data will be held securely on an SA health RAH Research network drive accessible only by research staff and not shared with other research groups this is because due to GPS monitoring of participants it is not entirely possible to de-identify raw IPD. At all times will confidentiality be upheld by the research staff.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5002	Study protocol					378376-(Uploaded-20-09-2019-17-29-56)-Study-related document.docx
5003	Informed consent form					378376-(Uploaded-05-10-2019-21-19-52)-Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically