Trial Review

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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] 299289 0
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 314415 0
Condition category
Condition code
Public Health 312757 312757 0 0
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] 315565 0
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] 321385 0
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] 321385 0
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] 321597 0
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] 321597 0
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 [3] 321729 0
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] 321729 0
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
Secondary outcome [1] 374838 0
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] 374838 0
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] 376253 0
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] 376253 0
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 [3] 376377 0
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] 376377 0
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 [4] 376378 0
To assess depression of ICU survivors using Hospital Anxiety Depression Scale (HADS) in both the smart phone and non smart phone groups
Timepoint [4] 376378 0
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.

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?
No
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)
SA
Recruitment hospital [1] 14789 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 28031 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303815 0
Hospital
Name [1] 303815 0
Royal Adelaide Hospital
Country [1] 303815 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 304027 0
None
Name [1] 304027 0
Address [1] 304027 0
Country [1] 304027 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304329 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 304329 0
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] 304329 0
Australia
Date submitted for ethics approval [1] 304329 0
22/08/2019
Approval date [1] 304329 0
Ethics approval number [1] 304329 0

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 96562 0
Dr Edward de'Lisle-Tarr
Address 96562 0
ICU research
Royal Adelaide Hospital
ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 96562 0
Australia
Phone 96562 0
+61451224261
Fax 96562 0
Email 96562 0
[email protected]
Contact person for public queries
Name 96563 0
Dr Edward de'Lisle-Tarr
Address 96563 0
ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 96563 0
Australia
Phone 96563 0
+61451224261
Fax 96563 0
Email 96563 0
[email protected]
Contact person for scientific queries
Name 96564 0
Dr Edward de'Lisle-Tarr
Address 96564 0
ICU research
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country 96564 0
Australia
Phone 96564 0
+61451224261
Fax 96564 0
Email 96564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
5002Study protocol    378376-(Uploaded-20-09-2019-17-29-56)-Study-related document.docx
5003Informed 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.