Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001547235
Ethics application status
Approved
Date submitted
5/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Total Cardiac Care: A randomised controlled trial of a smartphone application and associated model of care in patients with cardiovascular disease.
Scientific title
Total Cardiac Care: A randomised controlled trial of a comprehensive smartphone application-centric model of care to improve outcomes in patients with cardiovascular disease.
Secondary ID [1] 296006 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 309529 0
Cardiac failure 309530 0
Condition category
Condition code
Cardiovascular 308355 308355 0 0
Coronary heart disease
Cardiovascular 308356 308356 0 0
Hypertension
Cardiovascular 308357 308357 0 0
Normal development and function of the cardiovascular system
Cardiovascular 308358 308358 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients assigned to the intervention group will receive the Total Cardiac Care smartphone application, as well as a bluetooth enabled automatic sphygmomanometer and weighing scale. The app also includes intrinsic physical activity monitoring and the ability to send educational and motivational notifications. This will include messages such as "did you know, at any age, physical activity will give you more energy and help you manage your weight?" and "most medications need to be taken for a long time so don't stop taking them without your doctor's advice." Approximately 50 unique messages are sent in total and the frequency is three messages per week.

The data gathered by the app will be monitored remotely by the research team, and abnormalities can be acted upon by contacting the patient or their healthcare providers. Patients will be required to measure their weight and blood pressure daily. Each participant will be involved for 6 months. They will continue to receive standard usual care.

The intervention has been developed by the Graduate School of Biomedical Engineering (UNSW) and the Austrian Institute of Technology.

Compliance with the intervention will be checked by assessing the frequency of transmitted data. If blood pressure and weight have not been entered in the last two days, then a reminder message is sent. If they have not been entered in 4 days, a message will be sent to contact the research team for help.

Intervention code [1] 312337 0
Treatment: Other
Comparator / control treatment
The control group will receive standard cardiac care, which would include medications, devices and follow up with their GP and cardiologist.
Control group
Active

Outcomes
Primary outcome [1] 307343 0
Hospital readmission rate. This will be assessed by questionnaire (asking the participant if they had any readmissions to hospital) and also by review of the hospital medical record.
Timepoint [1] 307343 0
30 days after the day of discharge. This will also be 30 days since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [1] 351536 0
Hospital readmission rate. This will be assessed by questionnaire (asking the participant if they had any readmissions to hospital) and also by review of the hospital medical record.
Timepoint [1] 351536 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [2] 351537 0
Major adverse cardiovascular endpoints (MACE). This will be assessed by review of the medical record.
Timepoint [2] 351537 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [3] 351538 0
Medication compliance (per MGL score)
Timepoint [3] 351538 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [4] 351539 0
Clinical parameters - fasting LDL level. This will be assessed by a blood test.
Timepoint [4] 351539 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [5] 351541 0
Quality of Life Score (EQ-5D score).
Timepoint [5] 351541 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [6] 351542 0
Exercise capacity, as measured by the six minute walk test (6MWT)
Timepoint [6] 351542 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [7] 351544 0
Cardiac rehabilitation participation and completion. This will be assessed by asking the patient if they attended cardiac rehabilitation and whether they completed the program.
Timepoint [7] 351544 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [8] 351566 0
Blood pressure. This will be measured using the Total Cardiac Care system.
Timepoint [8] 351566 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [9] 351567 0
Waist circumference. This will be manually measured using measuring tape..
Timepoint [9] 351567 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [10] 351568 0
Body mass index. This will be calculated by measuring the height and weight of the participant. Height will be measured by a stadiometer. Weight will be measured by digital scales.
Timepoint [10] 351568 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.
Secondary outcome [11] 351702 0
Fasting HDL. This will be assessed by a blood test.
Timepoint [11] 351702 0
6 months after the day of discharge. This will also be 6 months since enrolment because participants will only be recruited in the trial on the day of discharge.

Eligibility
Key inclusion criteria
1. Patient is admitted to hospital with either an acute coronary syndrome or heart failure
2. Patient owns a compatible smartphone
3. Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to use the TCC app and peripheral devices due to reasons including but not limited to:
o Cognitive impairment
o Impaired dexterity to operate the app
o Visual impairment that would not allow adequate operation of the app
• Overseas travel
o Any overseas travel in the first 30 days after enrolment
o Any overseas travel longer than 1 month duration
o If travelling overseas for less than 1 month, the involvement of the participant is to be discussed. Options may include not using the app for the period of time spent abroad.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
RCT participants will be randomised in a 1:1 ratio stratified by primary diagnosis and enrolment site. Patients enrolled in the Usability Study will not be included in the final analysis. All tests will be 2-sided with a power of 80% and significance set at 5%. Descriptive statistics will be employed.

The primary outcome analysis
28-day readmission rates will be presented as percentages (n/N) in the intention-to-treat population and compared using a logistic regression model with adjustment for primary diagnosis and baseline characteristics.
As a secondary analysis, the primary endpoint will be compared in a per-protocol population, i.e., only patients who demonstrated use of the app in the intervention group will be included in the analysis.

Secondary endpoints
Secondary endpoints will be compared using intention-to-treat and per protocol analyses. Categorical variables will be presented as percentages (n/N) and compared using the chi-squared or Fisher’s exact test as appropriate. Continuous variables will be presented as median and interquartile range and compared using Wilcoxon rank-sum test for medians. 28 day MACE events will be presented and percentages. Six month events will be presented as Kaplan-Meier estimates and compared using the log-rank test. Subgroup analyses will be performed for gender, age, geography and primary diagnosis.

Power Calculations
The 28-day readmission rate among 1754 analogous patients admitted over a recent 12 month period was ~15%. Assuming a similar readmission rate in the control group, 986 patients will need to be randomised to detect a relative risk reduction (RRR) of 40% with 80% power and with two-sided type I error of 0.05. We propose ultimately recruiting 1080 patients to allow for a 10 percent dropout rate, which represents <30% of the eligible population. 300 patients from this single-centre trial will initially be recruited and another 780 patients may be recruited in a future study, should the necessary funding be secured.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11791 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 11792 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 11793 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 11794 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 11795 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 23917 0
2031 - Randwick
Recruitment postcode(s) [2] 23918 0
2229 - Caringbah
Recruitment postcode(s) [3] 23919 0
2170 - Liverpool
Recruitment postcode(s) [4] 23920 0
2065 - St Leonards
Recruitment postcode(s) [5] 23921 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 300602 0
Hospital
Name [1] 300602 0
Prince of Wales Hospital
Country [1] 300602 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
High St
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 300105 0
None
Name [1] 300105 0
Address [1] 300105 0
Country [1] 300105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301389 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301389 0
Ethics committee country [1] 301389 0
Date submitted for ethics approval [1] 301389 0
Approval date [1] 301389 0
26/04/2018
Ethics approval number [1] 301389 0
18/008 (HREC 18/POWH/91)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3081 3081 0 0
/AnzctrAttachments/375945-2018.04.26 HREA NEAF Ethics Approval 18-008 signed.pdf (Ethics approval)
Attachments [2] 3082 3082 0 0
/AnzctrAttachments/375945-Protocol 2.2 March 2018.docx (Protocol)
Attachments [3] 3083 3083 0 0
/AnzctrAttachments/375945-Master PISCF Version 2.2 March 2018.docx (Participant information/consent)

Contacts
Principal investigator
Name 86838 0
Dr Sze-Yuan Ooi
Address 86838 0
Eastern Health Clinic
Level 3 Dickinson Building
Prince of Wales Hospital
Randwick NSW 2031
Country 86838 0
Australia
Phone 86838 0
+61293820770
Fax 86838 0
Email 86838 0
[email protected]
Contact person for public queries
Name 86839 0
Praveen Indraratna
Address 86839 0
Eastern Health Clinic
Level 3 Dickinson Building
Prince of Wales Hospital
Randwick NSW 2031
Country 86839 0
Australia
Phone 86839 0
+61409311839
Fax 86839 0
Email 86839 0
[email protected]
Contact person for scientific queries
Name 86840 0
Praveen Indraratna
Address 86840 0
Eastern Health Clinic
Level 3 Dickinson Building
Prince of Wales Hospital
Randwick NSW 2031
Country 86840 0
Australia
Phone 86840 0
+61409311839
Fax 86840 0
Email 86840 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Smartphone-Based Model of Care to Support Patients With Cardiac Disease Transitioning From Hospital to the Community (TeleClinical Care): Pilot Randomized Controlled Trial.2022https://dx.doi.org/10.2196/32554
N.B. These documents automatically identified may not have been verified by the study sponsor.