Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000702617
Ethics application status
Approved
Date submitted
8/05/2023
Date registered
30/06/2023
Date last updated
30/10/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Partnering RemoTe monitoring of Implanted Cardiac devices with Intelligent PATient Engagement – PARTICIPATE Trial: A pilot study for efficacy and implementation feasibility
Scientific title
Partnering RemoTe monitoring of Implanted Cardiac devices with Intelligent PATient Engagement – PARTICIPATE Trial: A pilot study for efficacy and implementation feasibility
Secondary ID [1] 309505 0
None
Universal Trial Number (UTN)
Trial acronym
PARTICIPATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure
 329783 0
Atrial Fibrillation 329784 0
Condition category
Condition code
Cardiovascular 326680 326680 0 0
Other cardiovascular diseases
Cardiovascular 326683 326683 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be composed of patient engagement initiatives to improve patient involvement in their management and understanding of their cardiac implantable electronic device (CIED) and cardiovascular condition. The patient engagement initiatives will include the using a text-messaging service (TextCare platform) and providing a two-way portal of communication.

The TextCare platform will provide regular (3-4 messages / week) semi-personalised SMS to the
participants over a six month. The message personalistion will be based on patient medical conditions, SMS preferences, diet preferences, exercise tolerance and CVD risk factor profile. SMS messages will provide succinct information and aid as a thought-provoking tool. These SMS messages will contain education on CIEDs and remote monitoring, cardiovascular disease (CVD) risk factor modification, information on relevant cardiac conditions and their management, as well as healthy lifestyle education and advice. SMS messages will be accompanied with URL links to websites for further information. The CIED and remote monitoring information content has been developed specifically for this population. Other cardiac and CVD information supplied will be sourced from our current TextCare message bank. URL links provided will direct patients to reputable websites such as the Heart Foundation and Biotronik information pages.

Furthermore, we will contact patients via SMS using the TextCare platform when the remote monitoring function of their CIED detects an atrial fibrillation (AF) burden, new onset AF, increased risk of heart failure exacerbation, implantable cardioverter-defibrillator (ICD) shock, non-transmission of CIED data. When detected, we will contact the patients via SMS to provide education, CIED data review and lifestyle management advice to prevent worsening and future recurrence of the clinical issue.

The communication portal will allow participants to directly communicate with the healthcare team for further clarification and information when required. The portal will be developed through the TextCare platform, where the PARTICIPATE health counsellor will review the messages on a daily basis followed by either responding to the SMS or to escalate the question/concern to the relevant healthcare team member.

The TextCare platform will be monitored via a central monitoring unit. This unit will be composed of a 1) Health counsellor to monitor the in-coming and out-going messages, 2) Cardiac technician to monitor the CIED remote monitored data and create SMS to contact the patient accordingly, 3) Medical officer to oversee the functions of the unit and, 4) Cardiologist to escalate any clinical concerns to.

The participants included in the study will be patients with CIED implantation planned or recently implanted and have at least one of the following indications for the CIED implantation: Heart failure, coronary artery disease (CAD), cardiac arrhythmia
Intervention code [1] 325933 0
Prevention
Intervention code [2] 325934 0
Treatment: Devices
Comparator / control treatment
The control group will not receive the intervention, rather receive current standard care of CIED remote monitoring and education for a duration of six months. Standard of care is heterogenous among device clinics but may include information and education on their new CIED and cardiovascular conditions. This information may be delivered face-to-face, via a brochure or online resources. A description for standard care for each site will be obtained.
Control group
Active

Outcomes
Primary outcome [1] 334548 0
To evaluate the impact of the PARTICIPATE program upon patient self-efficacy managing their CIED compared to those in the control group receiving standard care using the using the Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale. There will be 16 questions, requiring a rating from 1-10. Each question will be tallied and divided by 16 providing an overall averaged number out of 10
Timepoint [1] 334548 0
The Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale will be completed 7 weeks following intervention commencement for each participant.
Secondary outcome [1] 421064 0
To evaluate the impact of the PARTICIPATE program upon patient self-efficacy managing their overall cardiovascular condition using the Cardiovascular Management Self-efficacy scale compared to those in the control group. There will be nine questions, requiring a rating from 1-5. Each question will be tallied and divided by nine providing an overall averaged number out of five.
Timepoint [1] 421064 0
The Cardiovascular Management Self-efficacy scale will be assessed at time of enrolment and again at completion of the intervention (6 months)
Secondary outcome [2] 421069 0
To evaluate the impact of the PARTICIPATE program upon healthcare utilisation (CVD and all-cause), compared to those in the control group receiving standard care. Healthcare utilisation for emergency department presentations and hospital admissions will be patient reported. from
Timepoint [2] 421069 0
Healthcare utilisation data will be collected for each patient at Week 7 and following completion of the 6 month intervention
Secondary outcome [3] 421070 0
-
Timepoint [3] 421070 0
-
Secondary outcome [4] 421073 0
-
Timepoint [4] 421073 0
Patient engagement with the intervention assessed by data collection on service use, survey and semi-structured interview will be deployed following completion of the 6 month intervention
Secondary outcome [5] 421076 0
To understand the barriers, enablers and areas of further improvement required for future wide-spread dissemination of the PARTICIPATE program. This implementation evaluation will be performed using the RE-AIM framework at the completion of the intervention. This framework assesses: ’Reach’, ‘Evaluation’, ‘Adoption’, ‘Implementation’ and ‘Maintenance’. This evaluation will be performed by assessing patient and healthcare team members opinions on the intervention and workflow process required via survey and semi-structured interviews.
Timepoint [5] 421076 0
This implementation evaluation performed via survey and semi-structured interviews will be conducted following completion of the 6 month intervention
Secondary outcome [6] 421084 0
-
Timepoint [6] 421084 0
-
Secondary outcome [7] 421085 0
-
Timepoint [7] 421085 0
-
Secondary outcome [8] 423409 0
To evaluate the impact of the PARTICIPATE program upon healthy lifestyle activities (vegetable/fruit consumption, physical activity levels, alcohol intake and smoking status/quantity) compared to those in the control group receiving standard care as assessed via patient survey.

Participant healthy lifestyle activities will be assessed using a survey designed specifically for this study. This outcome will be a composite of the uptake of the following lifestyle activities: vegetable/fruit consumption, physical activity levels, alcohol intake and smoking status/quantity.
Timepoint [8] 423409 0
The healthy lifestyle activity analysis will be assessed at time of enrolment and again at completion of the intervention (6 months).
Secondary outcome [9] 428371 0
To evaluate the impact of the PARTICIPATE program upon patient self-efficacy managing their CIED remote monitoring using using an internally developed survey compared to those in the control group. There will be three questions, requiring a rating from 0-10. Each question will be tallied and divided by three providing an overall averaged number out of 10.
Timepoint [9] 428371 0
Secondary outcome [10] 428372 0
To evaluate the impact of the PARTICIPATE program upon patient self-efficacy managing their CIED remote monitoring using using an internally developed survey compared to those in the control group. There will be three questions, requiring a rating from 0-10. Each question will be tallied and divided by three providing an overall averaged number out of 10.
Timepoint [10] 428372 0
The CIED remote monitoring self-efficacy survey will be completed 7 weeks following intervention commencement for each participant.
Secondary outcome [11] 428373 0
To evaluate the impact of the PARTICIPATE program upon patient quality of life using using the SF-12 instrument compared to those in the control group. There will be 12 questions involved with the SF-12 instrument
Timepoint [11] 428373 0
The CIED remote monitoring self-efficacy survey will be completed 7 weeks following intervention commencement for each participant.
Secondary outcome [12] 428374 0
To evaluate the impact of the PARTICIPATE program upon patient quality of life using using the SF-12 instrument compared to those in the control group. There will be 12 questions involved with the SF-12 instrument
Timepoint [12] 428374 0
The SF-12 instrument survey will be completed at baseline and intervention completion (6 months)
Secondary outcome [13] 428375 0
To evaluate the impact of the PARTICIPATE program upon patient motivation to improve cardiovascular health and CIED self-management using using an internally developed survey compared to those in the control group. There will be five questions, requiring a rating from 1-5. Each question will be tallied and divided by five providing an overall averaged number out of five.
Timepoint [13] 428375 0
The SF-12 instrument survey will be completed at baseline and intervention completion (6 months)
Secondary outcome [14] 428376 0
To evaluate the impact of the PARTICIPATE program upon patient motivation to improve cardiovascular health and CIED self-management using using an internally developed survey compared to those in the control group. There will be five questions, requiring a rating from 1-5. Each question will be tallied and divided by five providing an overall averaged number out of five.
Timepoint [14] 428376 0
The instrument will be completed at intervention completion (6 months)

Eligibility
Key inclusion criteria
18 years and older

Planned implantation of a CIED or has had a CIED implanted recently (within last month)

CIED equipped with remote monitoring capacity

CIED equipped with atrial sensing capacity

Indication of CIED implantation of Heart failure, Coronary artery disease (post myocardial infarction), Cardiac arrhythmia (including primary or secondary prevention of cardiac arrhythmia).

Owns and able to operate a mobile phone (SMS and phone calls)

Be able to read and follow instructions in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of dementia

Resides in a residential aged care facility (Nursing home)

Inability to provide informed consent

Inability to access the internet

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer

The study follows a PROBE (Prospective Randomized Open Blinding End-point) design. Participants will be aware of their allocations as will study cardiac technicians, however researchers analysing the data will be blinded to treatment allocation.

Randomisation of intervention and control will be in the ratio 1:1 and stratified by CIED type and site of recruitment. It will be conducted by REDCap. Once the patient has consented, information has been collected, and data has been entered, the online randomisation will allocate participants to an intervention group of receiving the PARTICIPATE program of CIED remote monitoring and education, or to a control group in which they will receive standard care of CIED remote monitoring and education for a duration of six months.


Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Randomisation of intervention and control will be in the ratio 1:1 and stratified by CIED type and site of recruitment. It will be conducted by REDCap. Once the patient has consented, information has been collected, and data has been entered, the online randomisation will allocate participants to an intervention group of receiving the PARTICIPATE program of CIED remote monitoring and education, or to a control group in which they will receive standard care of CIED remote monitoring and education for a duration of six months.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial is designed to test the study hypotheses with a conventional two-sided p-value of 0.05 and a statistical power (1-ß) of 90%. Event rates are based on the estimated event rates of the trial by Lau et al. An average ‘Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation’ Score of 7.98 for patients in the control group was estimated based on the trial by Lau et al. Including a dropout rate of 15% during the run-in phase of the study, a number of 100 patients will be enrolled, the study will be powered to detect a minimum difference of 1.07 increase in ‘Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation’ score from 7.98 to 9.05 with a standard deviation of 1.5.

A detailed analysis plan will be developed and finalised prior to data lock and unblinding of researchers analysing the data. All analyses of study outcomes will be conducted according to the principle of intention-to-treat. Two-tailed P values < 0.05 will be considered statistically significant.

Primary outcome analysis
The primary outcome, patient self-efficacy managing CIED using the Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale will be reported as mean and standard deviation and will be compared between the intervention and control group using Student’s t-tests or Mann-Whitney tests.

Secondary outcomes analyses
Patient self-efficacy managing overall CVD condition using the Cardiovascular Management Self-efficacy tool will be reported as mean and standard deviation and will be compared between the intervention and control group using Student’s t-tests or Mann-Whitney tests

Healthacre utilisation analysis will be reported as frequency and percentages and will be compared between the intervention and control group using Student’s t-tests or Mann-Whitney tests

The number and frequency of CIED remote monitored clinical issues and number of days with appropriate CIED data transfer will be reported as frequency and percentages.

Clinical health outcomes (quality of life, motivation to improve CV health and healthy lifestyle behaviours) will be reported as frequency and percentages and will be compared between the intervention and control group using Chi-square tests

Implementation process evaluation
Patient engagement with the PARTICIPATE program will be assessed for those in the intervention group at the completion of the intervention. Engagement will be assessed quantitatively by analysing the interaction with SMS messages and contacting healthcare team for review. Furthermore, a qualitative assessment will occur through semi-structured interviews where patients will describe how/why they used these services

Implementation evaluation will be performed using the RE-AIM framework[32] at the completion of the intervention. This framework assesses: ’Reach’, ‘Evaluation’, ‘Adoption’, ‘Implementation’ and ‘Maintenance’. This evaluation will be performed by assessing patient and healthcare team members opinions on the intervention and workflow process required.

Reach
Reach will be assessed objectively, by measuring the number of patients, cardiologists, cardiac technicians and LHDs agreeing to partake in the program.

Evaluation
Evaluation will be assessed via self-efficacy assessment, healthcare utilisation assessment and clinical outcome assessments.

Adoption
Adoption will be assessed by interviewing the stakeholders involved with facilitating the PARTICIPATE program, specifically assessing for any adaptions that were required to improve the delivery of the program.

Implementation
Implementation will be assessed by interviewing the stakeholders involved with facilitating the PARTICIPATE program and deployment of end-of-intervention survey. Surveys will be from both patient and healthcare provider stand-points on the effectiveness of implementing the PARTICIPATE program. Healthcare team members will provide perspective on their overall; satisfaction, acceptance, utility, and ease-of-use of the system. Patients will provide perspective on the utility, efficacy, and satisfaction with the program. Furthermore, clinical issues detected from remote monitored will be monitored and analysed between groups.

Maintenance
Maintenance will be assessed by interviewing the stakeholders involved with facilitating the PARTICIPATE program, specifically assessing the barriers, enablers and required areas of improvement, highlighting areas of focus for future patient engagement improvements.

Patient engagement
Participant interviews and surveys will be conducted following the conclusion of the 6-month intervention period to gain insight on the implemented patient engagement initiatives. Participants will provide perspectives on their overall satisfaction, acceptance, comfortability, and perceived utility of the PARTICIPATE program. Furthermore, interviews will aim to elicit perceived barriers and enablers of the program, highlighting areas of focus for future patient engagement improvements.

Implementation process evaluation will be conducted among intervention participants and health providers and will be analysed using quantitative and qualitative data from interviews and surveys. Thematic analysis will be conducted. The designated researcher will perform line by line coding of imported data and inductively delineate key concepts and then group related concepts into themes. The coding hierarchy will be reviewed by second investigator for quality assurance and rigour, and themes will be discussed between investigators to ensure breadth and depth of content has been appropriately captured. Member checking with participants will be conducted to elicit comment and feedback. Quantitative survey data will be reported as frequency and percentages and will be compared between the intervention and control group using Cho-square tests or Student’s t-tests or Mann-Whitney tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24582 0
Westmead Hospital - Westmead
Recruitment hospital [2] 24583 0
Westmead Private Hospital - Westmead
Recruitment hospital [3] 24587 0
Wollongong Hospital - Wollongong
Recruitment hospital [4] 25789 0
Victorian Heart Hospital - Clayton
Recruitment hospital [5] 25790 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 40178 0
2145 - Westmead
Recruitment postcode(s) [2] 40182 0
2500 - Wollongong
Recruitment postcode(s) [3] 41615 0
3168 - Clayton
Recruitment postcode(s) [4] 41616 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 313696 0
Other Collaborative groups
Name [1] 313696 0
Australian Stroke Heart Research Accelerator
Country [1] 313696 0
Australia
Funding source category [2] 313698 0
Commercial sector/Industry
Name [2] 313698 0
Biotronik Pty Ltd
Country [2] 313698 0
Australia
Funding source category [3] 313699 0
University
Name [3] 313699 0
The University of Sydney
Country [3] 313699 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315503 0
Other Collaborative groups
Name [1] 315503 0
Australian Stroke Heart Research Accelerator
Address [1] 315503 0
Monash University, Wellington Road, Clayton, Victoria, Australia, 3800
Country [1] 315503 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312863 0
Western Sydney Local Health District (WSLHD) Human Research Ethics Committees (HREC)
Ethics committee address [1] 312863 0
Ethics committee country [1] 312863 0
Australia
Date submitted for ethics approval [1] 312863 0
19/01/2023
Approval date [1] 312863 0
03/05/2023
Ethics approval number [1] 312863 0
2023/ETH00105

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

Contacts
Principal investigator
Name 126170 0
Prof Clara Chow
Address 126170 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre (WARC)

Level 5, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 126170 0
Australia
Phone 126170 0
+61 2 8627 3580
Fax 126170 0
Email 126170 0
[email protected]
Contact person for public queries
Name 126171 0
Brodie Sheahen
Address 126171 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre (WARC)

Level 5, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 126171 0
Australia
Phone 126171 0
+61 488975865
Fax 126171 0
Email 126171 0
[email protected]
Contact person for scientific queries
Name 126172 0
Brodie Sheahen
Address 126172 0
The University of Sydney, Faculty of Medicine and Health, Westmead Applied Research Centre (WARC)

Level 5, Block K | Entrance 10, Westmead Hospital | Hawkesbury Road Westmead, NSW, 2145
Country 126172 0
Australia
Phone 126172 0
+61 488975865
Fax 126172 0
Email 126172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact principal investigator via [email protected]


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.