Partnering RemoTe monitoring of Implanted Cardiac devices with Intelligent PATient Engagement - PARTICIPATE trial: a protocol for a randomised controlled trial

Open Heart. 2024 Nov 27;11(2):e002763. doi: 10.1136/openhrt-2024-002763.

ABSTRACT

INTRODUCTION: Cardiac implantable electronic devices (CIED) can transfer data to the healthcare team, remotely. National and international cardiac organisations recommend all patients use this technology, however patient engagement is suboptimal. Previously, in cardiovascular patients, SMS messaging services have shown improvements in patient engagement and subsequent health outcomes. This paper describes the protocol and intervention of a randomised controlled trial (RCT) to assess the feasibility of a novel CIED remote monitoring SMS patient support programme on self-efficacy in managing CIED and cardiovascular health following CIED implantation.

METHODS/ANALYSIS: A two-arm RCT will be conducted of 100 participants with 1:1 allocation to intervention or control. Participants awaiting-CIED or immediately post-CIED implantation from sites throughout Australia will be invited to partake. The intervention group will receive regular SMS communication with a range of educational and self-efficacy resources, in conjunction with engagement initiatives following CIED clinical issue detection. The control group will receive CIED remote monitoring education and clinical issue management as per standard practice at their respective sites. The primary outcome will assess the patient's capacity to manage their CIED as measured by the 'Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale'. Secondary outcomes will assess participant's ability to manage their cardiovascular condition, CIED remote monitoring, quality of life, impact on health service utilisation, cardiovascular behavioural risk factor change and motivation to improve cardiovascular health. A sample size of 100 will have a 90% power to detect a minimum difference of 1.07 in the 'Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale' between the intervention and control group with an alpha value of 0.05.

ETHICS AND DISSEMINATION: Ethics approval for this study has been obtained from the Western Sydney Local Health District Human Research Ethics Committee. The project results will be published in peer-reviewed journals, at scientific meetings and in the media.

TRIAL REGISTRATION NUMBER: ACTRN12623000702617.

PMID:39608860 | DOI:10.1136/openhrt-2024-002763