Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000030572
Ethics application status
Approved
Date submitted
8/11/2023
Date registered
15/01/2024
Date last updated
1/06/2024
Date data sharing statement initially provided
15/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient empowered monitoring in patients with heart failure and kidney disease at high risk of hospital readmission.
Scientific title
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
Secondary ID [1] 310918 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 331978 0
chronic kidney disease 331979 0
Condition category
Condition code
Cardiovascular 328716 328716 0 0
Other cardiovascular diseases
Renal and Urogenital 328717 328717 0 0
Kidney disease
Public Health 328718 328718 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327346 0
Treatment: Devices
Intervention code [2] 327347 0
Behaviour
Comparator / control treatment
Historical control: 12 months of retrospective admission and outpatient data will be collected on the trial participant to allow comparison to the active trial period. For example if a participant enrolls on 1st Feb 2024, the number of admissions, outpatient attendance, and GP attendance for the previous 12 months will be collected (1st Feb 2023 - 31 Jan 2024), from hospital record, My Health Record, and self-report.
Control group
Historical

Outcomes
Primary outcome [1] 336522 0
To outline the user experience of patient empowered monitoring and phone application.
Timepoint [1] 336522 0
Baseline data compared to 3 months & 6 months post intervention commencement
Primary outcome [2] 336523 0
To evaluate the user acceptance of this new model of care.
Timepoint [2] 336523 0
At end of trial (6 months post intervention commencing)
Primary outcome [3] 336524 0
To evaluate the clinician acceptance of this new model of care.
Timepoint [3] 336524 0
At end of trial (6 months post intervention commencing)
Secondary outcome [1] 428691 0
Any change in patient ability to self manage and have greater agency over health.
Timepoint [1] 428691 0
Baseline (before intervention), 3months of intervention and 6months (end of intervention)
Secondary outcome [2] 428700 0
Change in the reported number of hospital admissions and outpatient appointments for complications of heart failure or chronic kidney disease.
Timepoint [2] 428700 0
6 months data prior to trial commencement and 6 months during trial will be compared.
Secondary outcome [3] 430108 0
To assess feasibility of incorporation into current HealthLink’s workflow (a program to support patients with complex health needs with high risk of readmission).
Timepoint [3] 430108 0
At end of trial (6-months post intervention commencement).
Noting review of process and risk mitigation throughout study duration.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Historical cohort. Each participant will serve as their own historical cohort for number of admissions and outpatient attendance in the 12 months prior to enrollment date.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a proof-of-concept and hypothesis generating trial. In the future a randomized control trial is planned, and this will be designed to address sample size and power calculations for clinical outcomes.

Quantitative analysis will be used to provide a description of the cohort. The number of admissions and outpatient reviews will be compared in the 6 months pre and 6 months of the active trial.

Quantitative analysis of quality of life scores, patient activation measure and self care of heart failure index will be measured and compared at baseline, 3 months and 6 months.

Qualitative assessment with semi-structured interviews will be undertaken. They will be analysed using Braun and Clarke's methodology using the process of data familiarisation, generating codes, generating themes, reviewing themes and producing the report. A minimum of two researchers will independently review and code the qualitative data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
17/04/2024
Date of last participant enrolment
Anticipated
3/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26633 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 42673 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 315179 0
Government body
Name [1] 315179 0
Western Health
Country [1] 315179 0
Australia
Funding source category [2] 315182 0
Commercial sector/Industry
Name [2] 315182 0
Sicura Health
Country [2] 315182 0
Australia
Primary sponsor type
Government body
Name
Western Health
Address
176 Furlong Road St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 317206 0
None
Name [1] 317206 0
Address [1] 317206 0
Country [1] 317206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314109 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 314109 0
Ethics committee country [1] 314109 0
Australia
Date submitted for ethics approval [1] 314109 0
25/08/2023
Approval date [1] 314109 0
16/10/2023
Ethics approval number [1] 314109 0
HREC/101378/MH-2023

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

Contacts
Principal investigator
Name 130442 0
A/Prof Craig Nelson
Address 130442 0
Sunshine Hospital, 176 Furlong Road St Albans 3021 VIC
Country 130442 0
Australia
Phone 130442 0
+61 03 8345 1348
Fax 130442 0
Email 130442 0
[email protected]
Contact person for public queries
Name 130443 0
Hannah Wallace
Address 130443 0
Sunshine Hospital, 176 Furlong Road St Albans 3021 VIC
Country 130443 0
Australia
Phone 130443 0
+61 3 8345 6666
Fax 130443 0
Email 130443 0
[email protected]
Contact person for scientific queries
Name 130444 0
Hannah Wallace
Address 130444 0
Sunshine Hospital, 176 Furlong Road St Albans 3021 VIC
Country 130444 0
Australia
Phone 130444 0
+61 3 8345 6666
Fax 130444 0
Email 130444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be available to protect patient privacy. Collated data will be available at completion to trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20851Study protocol  [email protected] Available on request (subject to plan for publicat... [More Details]
20853Informed consent form    Available on request.
20854Ethical approval  [email protected] Available on request. Reference number HREC/1013... [More Details]
21375Statistical analysis plan  [email protected] Avaliable on request



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.