None listed
Conditions
Brief summary
This study aims to examine the efficacy of a novel CIED remote monitoring management program into a community setting, focussing on clinical patient outcomes, experience, and implementation feasibility. 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) to provide education and lifestyle advice, as well as contacting and educating patient when a clinical issue is detected via their CIED remote monitor. Additionally, the intervention will provide a two-way portal of communication for patients to interact with their healthcare team. 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 primary analysis is 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 between 4-8 weeks following intervention commencement. This is a pilot study. It will include a two-arm, randomised control trial of patients with CIEDs and known heart failure and/or atrial arrhythmia, comparing standard remote monitoring to remote monitoring complimented with the PARTICIPATE education. The trial component will also be supplemented by an implementation evaluation.
Interventions
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. T
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
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
Diagnosis of dementia Resides in a residential aged care facility (Nursing home) Inability to provide informed consent Inability to access the internet
Outcome results
None listed