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Trial registered on ANZCTR


Registration number
ACTRN12618000867291
Ethics application status
Approved
Date submitted
17/05/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a smartphone app to monitor activity and participation in patients undergoing cardio-thoracic surgery
Scientific title
The use of a smartphone app to monitor patient function and activity before and after cardiothoracic surgery
Secondary ID [1] 294919 0
The SMART-HEART Study
Universal Trial Number (UTN)
U1111-1214-2166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Heart Disease 307881 0
Valvular Heart Disease 307882 0
Condition category
Condition code
Cardiovascular 306930 306930 0 0
Coronary heart disease
Cardiovascular 306931 306931 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Use of a smartphone app to record step and GPS data and responses to a questionnaire before and after Cardio-thoracic surgery. At least 7-days of step and GPS data prior to surgery and 6 months post surgery.
Intervention code [1] 301235 0
Diagnosis / Prognosis
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305913 0
Number of days of complete returned GPS data - GPS data is to be collected every 5 minutes. Every 24 hours will provide 288 readings. If 80% (230 readings) are present the day will be counted as complete.
Timepoint [1] 305913 0
7 days prior to and 6 months post surgery
Primary outcome [2] 305914 0
Number of days of complete returned step data - Daily Step-data completeness will be assessed by counting the number of days where there is a difference between first and last step of > 10 hours, incomplete data will be any day where step data is reported, but <10 hours are reported. Step data will be obtained from the cloud database - that in turn will get its data from the smartphone app
Timepoint [2] 305914 0
7 days prior to and 6 months post surgery
Primary outcome [3] 305915 0
Patient satisfaction with a study specific questionnaire
Timepoint [3] 305915 0
6 months post surgery
Secondary outcome [1] 347011 0
Mean daily step count from data in the cloud database, data in the cloud database is wireless reported from a smartphone app
Timepoint [1] 347011 0
7 days prior to and 6 months post surgery
Secondary outcome [2] 347012 0
Mean daily step cadence from data in the cloud database, data in the cloud database is wireless reported from a smartphone app
Timepoint [2] 347012 0
7 days prior to and 6 months post surgery
Secondary outcome [3] 347013 0
Time spent inactive from data in the cloud database, data in the cloud database is wireless reported from a smartphone app
Timepoint [3] 347013 0
7 days prior to and 6 months post surgery
Secondary outcome [4] 347014 0
Standard Deviation Ellipse (SDE) activity space will be calculated from data in the cloud database, data in the cloud database is wireless reported from a smartphone app. The activity space will be calculated in ARC GIS
Timepoint [4] 347014 0
7 days prior to and 6 months post surgery
Secondary outcome [5] 347015 0
Minimum Convex Polygon (MCP) activity space will be calculated from data in the cloud database, data in the cloud database is wireless reported from a smartphone app. The activity space will be calculated in ARC GIS
Timepoint [5] 347015 0
7 days prior to and 6 months post surgery
Secondary outcome [6] 347016 0
Percentage time spent at home will be calculated from data in the cloud database, data in the cloud database is wireless reported from a smartphone app. Home will be coded as a 200m radius from a location the participant has spent the most time at.
Timepoint [6] 347016 0
7 days prior to and 6 months post surgery
Secondary outcome [7] 347017 0
Number of destinations visited will be calculated from data in the cloud database, data in the cloud database is wireless reported from a smartphone app. A destinationis calculated using the Spatio-Temporal Density-Based Spatial Clustering of Applications with Noise (ST-DBSCAN) tool.
Timepoint [7] 347017 0
7 days prior to and 6 months post surgery
Secondary outcome [8] 347018 0
Linear distance traveled will be calculated from data in the cloud database, data in the cloud database is wireless reported from a smartphone app. The haversine formula will be used to calculate the difference between each GPS point and summed to give a daily total, with the mean daily distance traveled over the study period being reported
Timepoint [8] 347018 0
7 days prior to and 6 months post surgery
Secondary outcome [9] 347019 0
Number of journeys made will be calculated as the number of changes in destination. A destinationis calculated using the Spatio-Temporal Density-Based Spatial Clustering of Applications with Noise (ST-DBSCAN) tool, using GPS data from the cloud database which is supplied with its data from the smartphone app.
Timepoint [9] 347019 0
7 days prior to and 6 months post surgery

Eligibility
Key inclusion criteria
• Aged >= 18
• They are undergoing CAG, valvular surgery or a combination;
• Their planned surgery is >7 days from recruitment;
• They own a smartphone;
• They have access to a home Wi-Fi network.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• They refuse to consent;
• They are not ambulatory at baseline (pre-morbidly not able to walk continuously for 5 minutes or more);
• Non-English speaker.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Continuous data will be described by mean (standard deviation) or median [interquartile range] depending upon normality of distribution. Categorical data will be summarized as number (percentage). Between group comparisons will be performed by t-test, rank-sum, or chi-squared distribution of frequencies as indicated.
Where repeated measures exist, population average point estimates and between group comparisons will employ generalized estimating equations.
Concordance between like measures will be assessed by Lin’s concordance correlation statistic and Bland-Altman limits of agreement.
Data will be imported into and analysed using Stata MP/15.1 – StataCorp LLC USA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2018
Actual
Date of last participant enrolment
Anticipated
30/11/2018
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 10916 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 10917 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 10918 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22678 0
5000 - Adelaide
Recruitment postcode(s) [2] 22679 0
5042 - Bedford Park
Recruitment postcode(s) [3] 22680 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 299501 0
Hospital
Name [1] 299501 0
Royal Adelaide Hospital
Country [1] 299501 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital
Port Rd
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 298802 0
University
Name [1] 298802 0
The University of Adelaide
Address [1] 298802 0
The University of Adelaide
North Terrace
Adelaide
SA 5000
Country [1] 298802 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300403 0
CALHN HREC
Ethics committee address [1] 300403 0
CALHN Research Office – Ethics and Governance
L3,
Roma Mitchell House,
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 300403 0
Australia
Date submitted for ethics approval [1] 300403 0
11/05/2018
Approval date [1] 300403 0
15/05/2018
Ethics approval number [1] 300403 0
HREC/18/CALHN/307

Summary
Brief summary
We are assessing the feasibility of using a smartphone app to monitor patients activity and participation. We will ask patients to install a smartphone app on their phone. Patients will install our app on their phone at least 7 days pre-op. The app will report step and GPS data and allow participants to respond to a questionnaire, data will be reported anonymously to a secure cloud database. They will then undergo surgery. We will follow them up for 6 months. before asking them a satisfaction questionnaire and deleting the app from their phone
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83550 0
Dr Samuel Gluck
Address 83550 0
ICU Research Department
4G751 - AM
RAH
Port Rd
Adelaide
SA 5000
Country 83550 0
Australia
Phone 83550 0
+61 8 70741758
Fax 83550 0
Email 83550 0
[email protected]
Contact person for public queries
Name 83551 0
Samuel Gluck
Address 83551 0
ICU Research Department
4G751 - AM
RAH
Port Rd
Adelaide
SA 5000
Country 83551 0
Australia
Phone 83551 0
+61 8 70741758
Fax 83551 0
Email 83551 0
[email protected]
Contact person for scientific queries
Name 83552 0
Samuel Gluck
Address 83552 0
ICU Research Department
4G751 - AM
RAH
Port Rd
Adelaide
SA 5000
Country 83552 0
Australia
Phone 83552 0
+61 8 70741758
Fax 83552 0
Email 83552 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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