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Patient empowered monitoring in patients with heart failure and kidney disease at high risk of hospital readmission.

Proof of concept trial: Investigating the user experience of patient empowered monitoring for patients with high-risk of readmission with heart failure and chronic kidney disease

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000030572
Enrollment
14
Registered
2024-01-15
Start date
2024-04-17
Completion date
2024-10-01
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

This is a proof of concept trial of a phone application with patient self-monitoring of biometrics in patients with heart failure and kidney disease. This patient population is at high risk of recurrent hospital admissions and require careful monitoring of their health and fluid status at home. The trial will involve the use of a wearable device (smart watch), digital scales and blood pressure machine, in combination with a phone application, to aid patients to self-manage their condition at home. They will be provided with a 24-hour phone service to call for advice and also provides triage to services based on need. The proof-of-concept study will run for 6 months and will evaluate usability, feasibility and acceptability of the model of care.

Interventions

Intervention: patient self monitoring of biometrics in combination with a phone application with digitised fluid management plan and hospital support. A program involving daily home monitoring of biometrics using a smart watch, Bluetooth scales and Bluetooth blood pressure machine. This will be paired with a phone application developed by Sicura Health with a fluid module activated. Biometric parameters will be set by the medical team. When outside set parameters feedback from the phone app is

Intervention: patient self monitoring of biometrics in combination with a phone application with digitised fluid management plan and hospital support. A program involving daily home monitoring of biometrics using a smart watch, Bluetooth scales and Bluetooth blood pressure machine. This will be paired with a phone application developed by Sicura Health with a fluid module activated. Biometric parameters will be set by the medical team. When outside set parameters feedback from the phone app is provided to the patient in the form of alerts, for example if a patient's weight has gone up by 2kg they will receive an alert to increase their diuretic medication. Each parameter blood pressure, heart rate and weight are individualised to the patient. Alerts range from instructing the patient to enact their self-management plan, through to critical red alerts requiring them to seek urgent medical attention. Patients will be encouraged to monitor daily for the 6 month duration of the trial. The blood pressure cuff is applied to the upper arm and links directly with the phone application. Participants will asked to measure their blood pressure each morning, by taking three readings. They will be asked to step on the weight scales when they wake up in the morning. They are asked to wear the SmartWatch every day, around the wrist. The team recommends wearing it at all times except in the shower or swimming. When patients are enrolled they will be provided with an education session that sets up the phone application and ensures it is connected to the blood pressure cuff, smart watch and scales. They will also be shown how to use the devices. Adherence to the intervention will be monitored by reviewing a log of records (for example blood pressure, weight, heart rate). Patients who are not using the intervention will be called and offered review to assist them with any difficulties. If despite addressing any issues, they are still unable to participate in monitoring they will withdrawn from the study. The fluid management plan is part of standard of care for patients with heart failure and kidney disease, and individualised to the patient. As part of standard care this is provided in written format with instructions to increase diuretic based on a weight increase. For this trial this will be digitalised and include weight, blood pressure and heart rate parameters. Only change in weight will trigger the alert to increase diuretic dose. Blood pressure and heart rate parameters being out of individualised range (e.g. HR 120) will trigger an alert for the patient call the hospital 24hour nursing number. This model will be integrated into existing workflows to enable timely community care. This includes a 24 hour nursing hospital number (this is already provided to patients with complex care needs) that patients can ring if alerted to. This leads to a triage process of phone advice, visiting a general practitioner, a rapid home assessment (within working hours), a rapid access specialist outpatient appointment or a recommendation to seek emergency assistance.

Sponsors

Western Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

- Adult patients (aged 18 years and over) - Able to give informed consent for medical decisions. - Have both heart failure and chronic kidney disease (stage 3-5) - Meet eligibility criteria for Health-Links program (hospital program for patients with chronic health needs at high risk of readmission noting most patients with heart failure and kidney disease would meet criteria). - Have an Apple phone device.

Exclusion criteria

- Participants who are unable to use a Smart phone / watch (or have someone who can assist them) - Participants who do not speak basic English (application currently in English). Note: study investigators acknowledge the exclusion criteria leads to a narrow and unique population that is not a representative sample. A future trial based on learnings and optimisation is planned that will broaden the inclusion/exclusion criteria to a range of consumer devices and common languages.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026