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Total Cardiac Care: A randomised controlled trial of a smartphone application and associated model of care in patients with cardiovascular disease.

Total Cardiac Care: A randomised controlled trial of a comprehensive smartphone application-centric model of care to improve outcomes in patients with cardiovascular disease.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001547235
Enrollment
1080
Registered
2018-09-17
Start date
2018-11-01
Completion date
2020-03-02
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Total Cardiac Care is a novel and innovative smartphone application-centric model of care aimed at supporting patients in the transition between hospital discharge and the community to improve health outcomes and reduce readmission rates. The patient’s smartphone is paired to a blood pressure monitor and weighing scales that allow the app to accurately track activity, heart rate, blood pressure and weight. The Total Cardiac Care (TCC) app-based model of care consists of two components: (1) a patient interface that supports healthy behaviour change, guided by the NSW Heart Foundation’s Managing My Heart Health resource; and (2) the central monitoring of patients from a virtual clinic with the support of a community-facing cardiac assessment unit to allow the early detection of decompensation and prevention of readmission to hospital. The aim of the project is to determine if the Total Cardiac Care smartphone application-centric model of care reduces the number of times patients with heart disease are re-admitted to hospital after being discharged.

Interventions

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

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.

Sponsors

Prince of Wales Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026