Westmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia
Westmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.
Open Heart. 2024 Nov 27;11(2):e002763. doi: 10.1136/openhrt-2024-002763.
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 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.
ACTRN12623000702617.
心脏植入式电子设备 (CIED) 可以向医疗保健团队远程传输数据。国家和国际心脏组织建议所有患者使用这项技术，但患者参与度不理想。以前，在心血管病患者中，短信消息服务已显示出改善患者参与度和随后的健康结果。本文描述了一项随机对照试验 (RCT) 的方案和干预措施，以评估一种新型 CIED 远程监测短信患者支持计划对 CIED 植入后管理 CIED 和心血管健康的自我效能的可行性。
方法/分析：将对来自澳大利亚各地的站点等待 CIED 或植入后立即的 100 名参与者进行 1:1 分配到干预组或对照组的两臂 RCT。将邀请干预组接受定期的 SMS 通信，其中包括一系列教育和自我效能资源，以及在 CIED 临床问题检测后进行参与度计划。对照组将按照各自站点的标准实践接受 CIED 远程监测教育和临床问题管理。主要结局将评估患者管理其 CIED 的能力，由“植入式心律转复除颤器后自我效能期望量表”测量。次要结局将评估参与者管理其心血管状况、CIED 远程监测、生活质量、对卫生服务利用的影响、心血管行为风险因素变化以及改善心血管健康的动机的能力。样本量为 100 人，将有 90%的能力检测出干预组和对照组之间“植入式心律转复除颤器后自我效能期望量表”的最小差异为 1.07，α 值为 0.05。
该研究已获得西悉尼地方卫生区人类研究伦理委员会的伦理批准。项目结果将发表在同行评议的期刊、科学会议和媒体上。
ACTRN12623000702617。
