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Trial registered on ANZCTR


Registration number
ACTRN12621001275853
Ethics application status
Approved
Date submitted
23/07/2021
Date registered
21/09/2021
Date last updated
21/09/2021
Date data sharing statement initially provided
21/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
I-TREAT: Intensive Follow-up via Remote Monitoring for Implantable Cardiac Devices
Scientific title
I-TREAT: Intensive Follow-up via Remote Monitoring for Implantable Cardiac Devices
Secondary ID [1] 301059 0
Nil
Universal Trial Number (UTN)
Trial acronym
I-TREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart arrythmias 317116 0
Heart rhythm disorder 318175 0
Condition category
Condition code
Cardiovascular 315277 315277 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intensive Remote Monitoring
Intensive remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock immediate processing of device alerts and scheduled downloads by trained technicians. Processed device data will be rapidly forwarded to the Cardiovascular Centre. The Cardiovascular Centre will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. Data collected though the cloud-base system includes all device and patient specific information, including time of alert, time at review, type of alert, time spent per alert response and actionable vs. non-actionable alerts.

The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants for the intervention group will be matched by age, gender and device type to the 70 patients in the standard care group.

There is no active participant involvement. Scheduled downloads occur every 6 months. Participants were followed up for 9 months, beginning September 2020. Information regarding subsequent interventions performed will not be collected.
Intervention code [1] 317365 0
Early Detection / Screening
Comparator / control treatment
Standard Remote Monitoring (RM)
Clinic staff will access RM data via individual device vendor internet-based interfaces as per standard practice which includes daily alert checks, scheduled downloads and contacting patients regarding transmissions or clinical action. Response to RM data transmissions will be at the discretion of the investigator.

Devices for this group will be derived from the Cardiovascular Centre home monitoring cohort and matched as close as possible by device type and age to the devices in the intensive RM group.
Control group
Active

Outcomes
Primary outcome [1] 324368 0
Time from event until intervention in case of actionable alert measured using data on transmission date and time, time to action and time to closing event which will be provided from the cloud-based system.
Timepoint [1] 324368 0
9 months post enrolment
Secondary outcome [1] 384479 0
Time from alert to review assessed using timestamp data
Timepoint [1] 384479 0
9 months post enrolment
Secondary outcome [2] 384480 0
Technician time spent per alert review assessed using timestamp data
Timepoint [2] 384480 0
9 months post enrolment
Secondary outcome [3] 384481 0
Technician time spend per alert response (contacting patient, treating clinician etc) assessed using timestamp data
Timepoint [3] 384481 0
9 months post enrolment
Secondary outcome [4] 384482 0
Proportion of alerts not requiring technician review after PaceMate alert adjudication will be assessed by audit of cloud-based system.
Timepoint [4] 384482 0
9 months post enrolment

Eligibility
Key inclusion criteria
This study will enrol devices across different brands including Biotronik, Boston Scientific, Medtronic and Abbott.

The only inclusion criteria is the device is on PaceMate (vendor neutral remote monitoring system).

The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants will be matched by age, gender and device type to those patients in the intensive remote-monitoring group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sorin devices on home monitoring as they are not on PaceMate

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Descriptive analysis will be undertaken, with time to event will be assessed. Statistical analysis will be performed with SPSS version 24.0 (SPSS, Inc., Chicago, IL, USA). Categorical variables are represented as frequencies and percentages. Continuous variables are summarized as mean ± SD. For categorical variables, differences between groups will be compared between groups using a Chi-squared test. Continuous variables were compared by way of an independent t-test. A p-value of p<0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/08/2020
Date of last participant enrolment
Anticipated
Actual
20/09/2020
Date of last data collection
Anticipated
Actual
20/06/2021
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305501 0
University
Name [1] 305501 0
University of Adelaide
Country [1] 305501 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
Royal Adelaide Hospital, Cardiology 4G751-769, The University of Adelaide, Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305899 0
None
Name [1] 305899 0
Address [1] 305899 0
Country [1] 305899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305813 0
Central Adelaide Health Network HREC
Ethics committee address [1] 305813 0
Royal Adelaide Hospital
Port Road, Adelaide SA 5000
Ethics committee country [1] 305813 0
Australia
Date submitted for ethics approval [1] 305813 0
19/06/2020
Approval date [1] 305813 0
10/08/2020
Ethics approval number [1] 305813 0

Summary
Brief summary
Remote monitoring (RM) has been established as advantageous in the follow-up of patients with implantable cardiac devices as a safe alternative to standard clinic follow-up. While RM is associated with various benefits, compliance is often sub optimal suggesting a more intensive model of RM is required.

The aim of the current trial is to determine the clinical utility, feasibility and workflow of implementing an intensive RM program compared to standard RM in patients with implantable cardiac devices.

We hypothesize that time from event to action will be shorter for patients in the intensive remote monitoring program compared to participants in the standard remote monitoring program.
Trial website
Trial related presentations / publications
Public notes
Recruitment will occur at the Cardiovascular Centre, a private Cardiologist Clinic. No recruitment will occur through hospitals.

Contacts
Principal investigator
Name 101686 0
Dr Melissa Middeldorp
Address 101686 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA
Country 101686 0
Australia
Phone 101686 0
+61 08 8313 9019
Fax 101686 0
Email 101686 0
[email protected]
Contact person for public queries
Name 101687 0
Melissa Middeldorp
Address 101687 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA
Country 101687 0
Australia
Phone 101687 0
+61 08 8313 9000
Fax 101687 0
Email 101687 0
[email protected]
Contact person for scientific queries
Name 101688 0
Melissa Middeldorp
Address 101688 0
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide SA 5000
AUSTRALIA
Country 101688 0
Australia
Phone 101688 0
+61 08 8313 9000
Fax 101688 0
Email 101688 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


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
SourceTitleYear of PublicationDOI
EmbaseImpact of intensive follow-up of cardiac implantable electronic devices via remote monitoring: A pilot study.2023https://dx.doi.org/10.1016/j.hroo.2022.11.002
N.B. These documents automatically identified may not have been verified by the study sponsor.