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Trial registered on ANZCTR


Registration number
ACTRN12623000059662
Ethics application status
Approved
Date submitted
6/01/2023
Date registered
17/01/2023
Date last updated
17/02/2023
Date data sharing statement initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of push notifications in the management of heart failure: a randomised pilot trial (NOTIFY-HF)
Scientific title
Feasibility of push notifications in the management of heart failure: a randomised pilot trial (NOTIFY-HF)
Secondary ID [1] 308565 0
None
Universal Trial Number (UTN)
Trial acronym
NOTIFY-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 328634 0
Condition category
Condition code
Cardiovascular 325640 325640 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Push notifications to patients with Heart Logic Score feedback.

Patients in the intervention arm will be registered for a web-app that will reside on their mobile phone home screen. Push notifications will be sent via this mechanism on a weekly basis for a minimum of 12 months following enrolment in the trial. The content of the notification will be determined based on their Heart Logic (HL) score, which will be transmitted via their pre-existing Boston Scientific HL compatible Cardiac Implantable Electronic Device (CIED) Home Monitoring via their Latitude platform. The participants will receive feedback on their HL score and be categorised into 3 groups via a "traffic light system" - green, amber and red. Participants with a normal HL score will be in the green zone, and will receive encouragement. Those with an abnormal HL score will receive a notification advising them of this, and be prompted to complete a symptom screening score. Those without symptoms will be categorized as 'Amber' and their notification will provide them with strategies for risk management, be reminded to take their medications, and given information on red flags to look out for. Those who are identified as having symptoms with an abnormal HL score will be categorised in the 'Red' group and will receive a notification advising the participant to seek medical review within 48 hours.

The intervention will be automated process using the Zedoc platform that has been developed by The Clinician. In the event that push notifications are not read by the participant, the Zedoc platform will alert the investigators and a reminder notification can be sent. Failure to respond following a reminder will result in a phone call to check that there are no technical issues prohibiting delivery of the notifications.
Intervention code [1] 325165 0
Behaviour
Intervention code [2] 325202 0
Treatment: Other
Comparator / control treatment
Usual care (no web-app or weekly push notification).

Participants in the usual care group will have their HL scores collected via home monitoring and in the event of an abnormal HL score alert being generated, their treating electrophysiologist who has been assigned their home monitoring privileges, will receive an alert notifying them that this patient has a HL score in the abnormal range. The electrophysiologist will action these alerts as per their usual practice. This could include a phone call, modification to medications, encouragement to see a GP or booking an early appointment with their treating cardiologist.
Control group
Active

Outcomes
Primary outcome [1] 333484 0
Feasibility of the NOTIFY-HF web-app and push-notifications in the remote-monitoring workflow of patients with Heart Logic-enabled Cardiac Implantable Exlectronic Devices (HL-CIEDs). Feasibility as defined by app analytics demonstrated completed app interactions without investigator intervention.
Timepoint [1] 333484 0
30 days, 6 months and 12 months post-commencement of the intervention
Primary outcome [2] 333485 0
Acceptability of the NOTIFY-HF web-app and push-notifications in the remote-monitoring workflow of patients with HL-CIEDs. Acceptability will be assessed through a validated questionnaire - the mHealth Usability Questionnaire (MAUQ).
Timepoint [2] 333485 0
30 days, 6 months and 12 months post-commencement of the intervention
Primary outcome [3] 333544 0
Effectiveness of the NOTIFY-HF web-app and implementation of push notifications on normalisation of HeartLogic score compared with usual care. This will be assessed by examining the remote monitoring of patients to determine the HL score, in conjunction with a review of patient medical records.
Timepoint [3] 333544 0
30 days, 6 months and 12 months post-commencement of the intervention
Secondary outcome [1] 417229 0
Heart failure hospitalisations (HFH). This will be collected by audit of patient medical records and questions regarding any recent unplanned medical (GP/Cardiologist) reviews, medication changes or hospitalisations during scheduled follow up appointments.
Timepoint [1] 417229 0
12 months post-recruitment to trial.
Secondary outcome [2] 417230 0
Quality of Life (KCCQ-12 score)
Timepoint [2] 417230 0
12 months post-recruitment to trial.
Secondary outcome [3] 417231 0
Heart Failure Medication Adherence. This outcome will be assessed through completion of the validated MMAS-8 Questionnaire.
Timepoint [3] 417231 0
12 months post-recruitment to trial.
Secondary outcome [4] 417232 0
All-Cause Hospitalisation. This will be collected by audit of patient medical records and questions regarding any unplanned hospitalisations during scheduled follow up appointments.
Timepoint [4] 417232 0
12 months post-recruitment to trial.
Secondary outcome [5] 417233 0
Cardiovascular Death. This will be collected by audit of patient medical records.
Timepoint [5] 417233 0
12 months post-recruitment to trial.
Secondary outcome [6] 417234 0
Major Adverse Cardiovascular Events (MACE) - A composite endpoint assessing stroke, myocardial infarction, and cardiovascular death. This will be collected by audit of patient medical records and questions regarding any recent unplanned medical (GP/Cardiologist) reviews or hospitalisations during scheduled follow up appointments.
Timepoint [6] 417234 0
12 months post-recruitment to trial.
Secondary outcome [7] 417235 0
All-cause death. This will be collected by audit of patient medical records and home-monitoring data.
Timepoint [7] 417235 0
12 months post-recruitment to trial.
Secondary outcome [8] 417236 0
Functional Capacity as assessed by 6 Minute Walk Test (6MWT)
Timepoint [8] 417236 0
At enrollment, Day 30, 6 months and 12 months post-recruitment to trial.
Secondary outcome [9] 417239 0
Heart Failure status as assessed by Mean Heart Logic Score
Timepoint [9] 417239 0
12 months post-recruitment to trial.
Secondary outcome [10] 417240 0
Change in HeartLogic score
Timepoint [10] 417240 0
At baseline, 6 months and 12 months post-recruitment to trial.
Secondary outcome [11] 417241 0
Patient activity level as measured by non-sedentary time detected by device-embedded accelerometer.
Timepoint [11] 417241 0
12 months post-recruitment to trial.

Eligibility
Key inclusion criteria
• Age 18 years or older
• English speaking
• Compatible Boston CIED capable of heart failure diagnostics (HeartLogic) and remote monitoring
• Heart Failure with reduced ejection fraction (HFrEF) with Ejection Fraction (EF) <50% or EF >50% with previous admission with heart failure with preserved ejection fraction (HFpEF) or EF >50% and prescribed oral loop diuretic
• 45 days post CIED implantation
• Compatible mobile phone with access to an internet connection
• Willingness to give written informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any non-cardiac disease that is likely to reduce life expectancy to less than 1 year
• Cognitive impairment
• Participation in another clinical trial that in the opinion of the investigator may interfere with participation in NOTIFY-HF

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be performed via central randomisation using 'R Studio' software with the Randomizr package.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be utilised using a randomisation table created by 'R Studio' software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23773 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 39220 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 312812 0
Hospital
Name [1] 312812 0
Liverpool Hospital
Country [1] 312812 0
Australia
Funding source category [2] 312962 0
University
Name [2] 312962 0
University of New South Wales
Country [2] 312962 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital Department of Cardiology
Address
Elizabeth St, Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 314457 0
None
Name [1] 314457 0
Address [1] 314457 0
Country [1] 314457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312096 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 312096 0
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7279 Eastern Campus Liverpool BC NSW 1871
Ethics committee country [1] 312096 0
Australia
Date submitted for ethics approval [1] 312096 0
Approval date [1] 312096 0
01/11/2022
Ethics approval number [1] 312096 0
2022/ETH01786

Summary
Brief summary
This trial will utilise information from Boston Scientific Cardiac Implantable electronic Devices remote monitoring and Heart Logic Algorithm and the NOTIFY-HF smart phone web-application to assist in the early identification of fluid overload. Evidence shows that heart failure decompensation events begin 4-6 weeks before the development of symptoms such as breathlessness or fluid retention.

The aim of this research project is to use this information obtained from your device via remote monitoring to provide feedback via push notifications to participants on their heart failure status.

The app, NOTIFY-HF, will provide a weekly update in an easy-to-understand manner with the hope of instigating behavioural changes that result in improvements in heart failure management.

The central hypothesis of the study is that push notifications guided by HeartLogic data will promote behavioural change that leads to improvements in heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123458 0
Dr Joseph Assad
Address 123458 0
Department of Cardiology
Liverpool Hospital
Elizabeth St,
Liverpool, NSW 2170
Country 123458 0
Australia
Phone 123458 0
+61 2 8738 7658
Fax 123458 0
Email 123458 0
joseph.assad@health.nsw.gov.au
Contact person for public queries
Name 123459 0
Dr Joseph Assad
Address 123459 0
Department of Cardiology
Liverpool Hospital
Elizabeth St,
Liverpool, NSW 2170
Country 123459 0
Australia
Phone 123459 0
+61 02 8738 3000
Fax 123459 0
Email 123459 0
joseph.assad@health.nsw.gov.au
Contact person for scientific queries
Name 123460 0
Dr Joseph Assad
Address 123460 0
Department of Cardiology
Liverpool Hospital
Elizabeth St,
Liverpool, NSW 2170
Country 123460 0
Australia
Phone 123460 0
+61 02 8738 3000
Fax 123460 0
Email 123460 0
joseph.assad@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
3 months and ending 5 years following main results publication
Available to whom?
Will be available on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims of the original project.
How or where can data be obtained?
Access subject to approvals by Principal Investigator who can be contacted by email: joseph.assad@health.nsw.gov.au


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.