Gibson Irene, Jennings Catriona, Neubeck Lis, Corcoran Marissa, Wood David, Sharif Faisal, Hynes Lisa, Murphy Andrew W, Byrne Molly, McEvoy John William
School of Medicine, University of Galway, Galway, Ireland.
National Institute for Prevention and Cardiovascular Health, Galway, Ireland.
HRB Open Res. 2025 Jan 31;6:43. doi: 10.12688/hrbopenres.13781.1. eCollection 2023.
Digital health interventions (DHIs) are increasingly used for the secondary prevention of cardiovascular disease (CVD). The aim of this study is to determine the feasibility of "INTERCEPT", a co-designed DHI developed to improve secondary prevention in hospitalised coronary heart disease patients (CHD).
This non-randomised, pilot feasibility study with embedded process evaluation will be conducted with a sample of 40 patients in an acute hospital setting. Informed by behaviour change theory, INTERCEPT integrates a smartphone interface, health care professional portal, a fitness wearable and a blood pressure monitor. INTERCEPT is designed to support and motivate patients to set goals, self-monitor lifestyle and medical risk factors, and manage their medications, with the health care professional portal enabling monitoring and communication with patients. Using consecutive sampling, eligible patients will be recruited in two phases, a pre-implementation phase and an implementation phase. Commencing with pre-implementation (1 month duration), participants will not immediately receive INTERCEPT, however, they will be invited to receive INTERCEPT at 3 months follow-up. This will enable early learning about the processes of recruitment and conducting the assessment prior to full scale deployment of INTERCEPT in the next step implementation phase. During the implementation phase (2 months duration), participants will be invited to download INTERCEPT to their smartphone prior to hospital discharge. Qualitative interviews will be conducted among a subset of patients and health care professionals to gain a greater insight into their experience of using INTERCEPT. Primary outcomes will be assessed at baseline and 3-month follow-up. Using pre-defined feasibility criteria, including recruitment, retention and engagement rates, together with data on intervention acceptability, will determine the appropriateness of progressing to a definitive trial.
This study will provide important insights to help inform the feasibility of conducting a definitive trial of "INTERCEPT" among coronary heart disease patients in a critical health care setting.
数字健康干预措施（DHIs）越来越多地用于心血管疾病（CVD）的二级预防。本研究的目的是确定“INTERCEPT”的可行性，这是一种共同设计的数字健康干预措施，旨在改善住院冠心病患者（CHD）的二级预防。
本项非随机、带有嵌入式过程评估的试点可行性研究将在一家急症医院对40名患者进行抽样。基于行为改变理论，“INTERCEPT”整合了智能手机界面、医疗保健专业人员门户、健身可穿戴设备和血压监测仪。“INTERCEPT”旨在支持并激励患者设定目标、自我监测生活方式和医学风险因素以及管理其药物，医疗保健专业人员门户则能够对患者进行监测并与之沟通。采用连续抽样法，符合条件的患者将分两个阶段招募，即实施前阶段和实施阶段。从实施前阶段（为期1个月）开始，参与者不会立即接受“INTERCEPT”，不过，他们将被邀请在3个月随访时接受“INTERCEPT”。这将有助于在下一步实施阶段全面部署“INTERCEPT”之前尽早了解招募和进行评估的过程。在实施阶段（为期2个月），参与者将在出院前被邀请将“INTERCEPT”下载到其智能手机上。将对一部分患者和医疗保健专业人员进行定性访谈，以更深入地了解他们使用“INTERCEPT”的体验。主要结局将在基线和3个月随访时进行评估。使用预定义的可行性标准，包括招募率、保留率和参与率，以及关于干预可接受性的数据，将确定是否适合开展确定性试验。
本研究将提供重要见解，以帮助了解在关键医疗保健环境中对冠心病患者进行“INTERCEPT”确定性试验的可行性。
