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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000888965
Ethics application status
Approved
Date submitted
23/06/2020
Date registered
10/09/2020
Date last updated
10/09/2020
Date data sharing statement initially provided
10/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Total Cardiac Care: a smartphone-based remote monitoring system for Heart Failure Patients
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Scientific title
Total Cardiac Care for Heart Failure Patients: Evaluation of the implementation of a comprehensive smartphone application-centric model of remote monitoring for vulnerable patients with heart failure (TCC-HF) in the community
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Secondary ID [1]
301611
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
heart failure
317992
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Condition category
Condition code
Cardiovascular
316025
316025
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
“TCC-Heart Failure” comprises a smartphone application which collects and transmits health data (oxygen saturation, blood pressure and weight) to a web-based server, where it can be monitored by a central research team. These data can be used to facilitate early review of participants whose parameters fall outside individualised, preset parameters (preset by the participant’s treating cardiologist). If such an event occurs, the participant will be contacted by a registered nurse, who will escalate the issue to the patient’s cardiologist or nurse practitioner if required.
Further, it provides summary feedback to the participant about their collected parameters and delivers educational messages regarding the management of heart failure via push notifications. Participants will be provided with the smartphone application which they will either download by instruction, or have downloaded for them by a member of the research team. Participants will also be provided with 1) A blood pressure machine 2) A weighing scale and 3) a pulse oximeter. Participants will be provided with Bluetooth enabled devices (where available) so that the data is automatically transmitted to the application. Manual data entry will take place for participants who are not provided a Bluetooth device (due to lack of availability). Participants will be required to provide data daily (where possible). The process will take less than 5 minutes per day. Participants will be requested to enter data daily for a total of 6 months. The intervention is administered by a multicentre research team comprising doctors, nurse practitioners and nurses at the local hospital that the participant is cared for at. Adherence to the intervention can be measured by analysis of the data, as all transmitted readings are available to the research team to view.
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Intervention code [1]
317914
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Treatment: Devices
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Intervention code [2]
318110
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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A process evaluation comprised of four separate primary endpoints is the overall aim. The first part of process evaluation will be assessed by quantification of how many potential participants were eligible to participate, and how many were recruited, this will be collected from medical records
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Assessment method [1]
324231
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Timepoint [1]
324231
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At the completion of the trial (when all participants have been enrolled for 6 months)
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Primary outcome [2]
324470
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To determine app engagement (based on log ins, daily entries for each category of parameter being assessed, additional notes by patients).
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Assessment method [2]
324470
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Timepoint [2]
324470
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At the completion of the trial (all participants enrolled for six months)
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Primary outcome [3]
324473
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Documentation of nature and prevalence of alerts, and the management of each. Each alert will be documented in a study database. This endpoint is considered a composite primary outcome.
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Assessment method [3]
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Timepoint [3]
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Completion of the trial - when all participants have completed the trial (i.e. all participants have been part of the trial for six months).
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Secondary outcome [1]
384121
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• Total unplanned heart failure-related health presentations - which is a composite of:
o General practitioner visits for heart failure
o Cardiologist visits for heart failure
o Emergency department presentations (with or without admission, including to the short stay unit)
o Hospital inpatient admissions
The endpoint will be assessed by medical record review, review of the heart failure service data, obtaining correspondence from the cardiologist and self-reported patient outcomes.
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Assessment method [1]
384121
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Timepoint [1]
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6 months post enrolment
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Secondary outcome [2]
384754
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App managers’ documentation of nature and prevalence of any technical issues that resulted in app malfunction. Each technical issue will be recorded in a database. These issues may either be self-reported by the participant, or identified by the monitoring team when data is not recorded by the participant. This endpoint is part of the primary endpoint
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Assessment method [2]
384754
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Timepoint [2]
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Completion of the trial - when all participants have completed the trial (i.e. all participants have been part of the trial for six months).
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Secondary outcome [3]
384757
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Mortality - assessed by medical record review and discussion with GP if appropriate
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Assessment method [3]
384757
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Timepoint [3]
384757
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6 months post enrolment.
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Secondary outcome [4]
384758
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Major adverse cardiovascular events (MACE: stroke, myocardial infarction, unplanned coronary revascularisation and death). Assessed by medical record review
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Assessment method [4]
384758
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Timepoint [4]
384758
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6 months post enrolment
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Secondary outcome [5]
384759
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Medication compliance (according to the Moritsky-Green-Levine (MGL) questionnaire
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Assessment method [5]
384759
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Timepoint [5]
384759
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Baseline (pre-enrolment) and 6 months post enrolment
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Secondary outcome [6]
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Quality of Life score (according to Kansas City Cardiomyopathy Questionnaire)
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Assessment method [6]
384760
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Timepoint [6]
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Baseline (pre-enrolment) and 6 months post enrolment
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Secondary outcome [7]
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Length of stay in any hospital readmission. Assessed by medical record review.
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Assessment method [7]
384761
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Timepoint [7]
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6 months post enrolment
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Secondary outcome [8]
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Reaching maximal or maximal tolerated dose of heart failure medications. Assessed by medication review.
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Assessment method [8]
384762
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Timepoint [8]
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6 months post enrolment
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Secondary outcome [9]
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New York Heart Association (NYHA) class. Assessed from participant self-report of symptoms described to the research team.
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Assessment method [9]
384763
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Timepoint [9]
384763
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Baseline (pre-enrolment) and 6 months post enrolment
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Secondary outcome [10]
384764
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Blood pressure. Measured by the research team at baseline and at the conclusion of the study using a sphygmomanometer.
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Assessment method [10]
384764
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Timepoint [10]
384764
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Baseline (pre-enrolment) and 6 months post enrolment
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Secondary outcome [11]
384765
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Weight. Measured by the research team at baseline and at the conclusion of the study using a digital scale.
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Assessment method [11]
384765
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Timepoint [11]
384765
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Baseline (pre-enrolment) and 6 months post enrolment
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Eligibility
Key inclusion criteria
• Patient who is under the care of, or newly referred to, the community heart failure service at one of the three involved hospitals OR a patient with heart failure who is directly referred to the research team by the treating cardiologist.
• Patient owns a smartphone or iPad that has the capability to operate the TCC application
• Age over 18 years
• Able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
• Lack of fluency with English language
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2020
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Actual
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Date of last participant enrolment
Anticipated
1/10/2020
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Actual
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Date of last data collection
Anticipated
1/04/2021
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
306039
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Hospital
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Name [1]
306039
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Prince of Wales Hospital
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Address [1]
306039
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Barker St, Randwick, NSW 2031
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Country [1]
306039
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Australia
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Funding source category [2]
306040
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Hospital
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Name [2]
306040
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Sutherland Hospital
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Address [2]
306040
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The Kingsway, Caringbah, NSW 2229
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Country [2]
306040
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Australia
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Funding source category [3]
306041
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Hospital
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Name [3]
306041
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St Vincents Hospital
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Address [3]
306041
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Victoria St, Darlinghurst, NSW, 2010
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Country [3]
306041
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Australia
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Funding source category [4]
306042
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Hospital
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Name [4]
306042
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Royal North Shore Hospital
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Address [4]
306042
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Reserve Rd, St. Leonards, NSW 2065
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Country [4]
306042
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Australia
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Primary sponsor type
Hospital
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Name
Prince of Wales Hospital
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Address
Barker St, Randwick, NSW 2031
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Country
Australia
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Secondary sponsor category [1]
306504
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None
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Name [1]
306504
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Address [1]
306504
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Country [1]
306504
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306269
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St Vincent's Hospital Human Research Ethics Committee
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Ethics committee address [1]
306269
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St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street
Darlinghurst NSW 2010
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Ethics committee country [1]
306269
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Australia
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Date submitted for ethics approval [1]
306269
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Approval date [1]
306269
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17/06/2020
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Ethics approval number [1]
306269
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Summary
Brief summary
The primary purpose of the study is to evaluate the implementation of a smartphone-app based model of care. Participants with heart failure will be provided with a smartphone app as well as equipment including a blood pressure machine, weighing scale and pulse oximeter. Participants will use the app to send their results daily to a monitoring team who will check for abnormal readings. Abnormal readings will be discussed with a doctor or nurse who is familiar with the participant, and treatment may be provided if necessary.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103306
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Dr Sze-Yuan Ooi
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Address
103306
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Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
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Country
103306
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Australia
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Phone
103306
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+61 2 93820700
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Fax
103306
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Email
103306
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[email protected]
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Contact person for public queries
Name
103307
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Dr Sze-Yuan Ooi
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Address
103307
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Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
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Country
103307
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Australia
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Phone
103307
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+61 2 93820700
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Fax
103307
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Email
103307
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[email protected]
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Contact person for scientific queries
Name
103308
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Dr Sze-Yuan Ooi
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Address
103308
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Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
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Country
103308
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Australia
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Phone
103308
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+61 2 93820700
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Fax
103308
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Email
103308
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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