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
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
Secondary ID [1] 301611 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 317992 0
Condition category
Condition code
Cardiovascular 316025 316025 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 317914 0
Treatment: Devices
Intervention code [2] 318110 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324231 0
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
Timepoint [1] 324231 0
At the completion of the trial (when all participants have been enrolled for 6 months)
Primary outcome [2] 324470 0
To determine app engagement (based on log ins, daily entries for each category of parameter being assessed, additional notes by patients).
Timepoint [2] 324470 0
At the completion of the trial (all participants enrolled for six months)
Primary outcome [3] 324473 0
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.
Timepoint [3] 324473 0
Completion of the trial - when all participants have completed the trial (i.e. all participants have been part of the trial for six months).
Secondary outcome [1] 384121 0
• 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.
Timepoint [1] 384121 0
6 months post enrolment
Secondary outcome [2] 384754 0
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
Timepoint [2] 384754 0
Completion of the trial - when all participants have completed the trial (i.e. all participants have been part of the trial for six months).
Secondary outcome [3] 384757 0
Mortality - assessed by medical record review and discussion with GP if appropriate
Timepoint [3] 384757 0
6 months post enrolment.
Secondary outcome [4] 384758 0
Major adverse cardiovascular events (MACE: stroke, myocardial infarction, unplanned coronary revascularisation and death). Assessed by medical record review
Timepoint [4] 384758 0
6 months post enrolment
Secondary outcome [5] 384759 0
Medication compliance (according to the Moritsky-Green-Levine (MGL) questionnaire
Timepoint [5] 384759 0
Baseline (pre-enrolment) and 6 months post enrolment
Secondary outcome [6] 384760 0
Quality of Life score (according to Kansas City Cardiomyopathy Questionnaire)
Timepoint [6] 384760 0
Baseline (pre-enrolment) and 6 months post enrolment
Secondary outcome [7] 384761 0
Length of stay in any hospital readmission. Assessed by medical record review.
Timepoint [7] 384761 0
6 months post enrolment
Secondary outcome [8] 384762 0
Reaching maximal or maximal tolerated dose of heart failure medications. Assessed by medication review.
Timepoint [8] 384762 0
6 months post enrolment
Secondary outcome [9] 384763 0
New York Heart Association (NYHA) class. Assessed from participant self-report of symptoms described to the research team.
Timepoint [9] 384763 0
Baseline (pre-enrolment) and 6 months post enrolment
Secondary outcome [10] 384764 0
Blood pressure. Measured by the research team at baseline and at the conclusion of the study using a sphygmomanometer.
Timepoint [10] 384764 0
Baseline (pre-enrolment) and 6 months post enrolment
Secondary outcome [11] 384765 0
Weight. Measured by the research team at baseline and at the conclusion of the study using a digital scale.
Timepoint [11] 384765 0
Baseline (pre-enrolment) and 6 months post enrolment

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
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
• Lack of fluency with English language

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2020
Actual
Date of last data collection
Anticipated
1/04/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306039 0
Hospital
Name [1] 306039 0
Prince of Wales Hospital
Country [1] 306039 0
Australia
Funding source category [2] 306040 0
Hospital
Name [2] 306040 0
Sutherland Hospital
Country [2] 306040 0
Australia
Funding source category [3] 306041 0
Hospital
Name [3] 306041 0
St Vincents Hospital
Country [3] 306041 0
Australia
Funding source category [4] 306042 0
Hospital
Name [4] 306042 0
Royal North Shore Hospital
Country [4] 306042 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker St, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 306504 0
None
Name [1] 306504 0
Address [1] 306504 0
Country [1] 306504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306269 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 306269 0
Ethics committee country [1] 306269 0
Australia
Date submitted for ethics approval [1] 306269 0
Approval date [1] 306269 0
17/06/2020
Ethics approval number [1] 306269 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103306 0
Dr Sze-Yuan Ooi
Address 103306 0
Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
Country 103306 0
Australia
Phone 103306 0
+61 2 93820700
Fax 103306 0
Email 103306 0
szeyuan.ooi@ehc.com.au
Contact person for public queries
Name 103307 0
Sze-Yuan Ooi
Address 103307 0
Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
Country 103307 0
Australia
Phone 103307 0
+61 2 93820700
Fax 103307 0
Email 103307 0
szeyuan.ooi@ehc.com.au
Contact person for scientific queries
Name 103308 0
Sze-Yuan Ooi
Address 103308 0
Eastern Heart Clinic
Level 3 Campus Centre
Prince of Wales Hospital
Barker St Randwick NSW 2031
Country 103308 0
Australia
Phone 103308 0
+61 2 93820700
Fax 103308 0
Email 103308 0
szeyuan.ooi@ehc.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.