Billis Antonis, Pandria Niki, Mouratoglou Sophia-Anastasia, Konstantinidis Evdokimos, Bamidis Panagiotis
Laboratory of Medical Physics, Faculty of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
JMIR Res Protoc. 2020 May 4;9(5):e17714. doi: 10.2196/17714.
Heart failure is a chronic disease affecting patient morbidity and mortality. Current guidelines for heart failure patient treatment are focused on improving their clinical status, functional capacity, and quality of life. However, these guidelines implement numerous instructions including medical treatment adherence, physical activity, and self-care management. The complexity of the therapeutic instructions makes them difficult to follow especially by older adults.
The challenge of this project is to (1) measure real-life adherence to a regular physical exercise program and (2) attempt to influence older adult patients with heart failure toward embracing a more physically active self-care lifestyle.
This research consists of two studies, including a lab experiment and a pragmatic evaluation of technology at patients' homes. The lab experiment aims at exploring in an objective way (measuring neurophysiological responses to stimuli) patient engagement with different characteristics of virtual agents, while the home study is a 3-phase prospective study where the developed technology platform is tested by heart failure patients in their own home environments. Patients undergo evaluation of their physical activity and cognitive status using standard evaluation methods (6-minute walk test, questionnaires) and receive wearable devices to accurately measure everyday life activity levels (home study phases 1-3). During home study phases 2 and 3, exergames (serious games for physical exercise) to provide a physical exercise plan as a joyful activity are delivered to patients' private households and e-coaching techniques are implemented in the final phase (home study phase 3) of the protocol, to influence patient attitudes toward a more healthy and recommended lifestyle.
The trial is still ongoing. Recruitment is ongoing, and the project has progressed for some participants through phase 2 of the home study. The sample size for both studies is 28 participants; 10 have already been included in the study, and both baseline clinical and patient-reported outcome data are retrieved. Phases 2 and 3 of the home pilot study are expected to be completed within 6 months.
The main challenge of the project is the change of attitude of older age heart failure patients through an e-coaching system. Given the adoption of a cocreation and living lab approach and the main objective for real-life evaluation, the project is ready to react to any collected feedback, even during the implementation of the research plan. Clinical assessment and objective evaluation are expected to provide all required information for reliable findings.
ClinicalTrials.gov NCT03877328; https://clinicaltrials.gov/ct2/show/NCT03877328.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17714.
心力衰竭是一种影响患者发病率和死亡率的慢性疾病。目前的心力衰竭患者治疗指南侧重于改善他们的临床状况、功能能力和生活质量。然而，这些指南包含了众多指示，包括药物治疗依从性、体育活动和自我护理管理。治疗指示的复杂性使得它们难以遵循，尤其是老年人。
本项目的挑战在于：（1）衡量对常规体育锻炼计划的实际依从性；（2）试图影响老年心力衰竭患者接受更积极的自我护理生活方式。
本研究包括两项研究，一项实验室实验和一项在患者家中对技术的务实评估。实验室实验旨在以客观方式（测量对刺激的神经生理反应）探索患者对虚拟代理不同特征的参与度，而家庭研究是一项为期3个阶段的前瞻性研究，在患者自己家中测试开发的技术平台。患者使用标准评估方法（6分钟步行测试、问卷调查）接受身体活动和认知状态评估，并获得可穿戴设备以准确测量日常生活活动水平（家庭研究第1 - 3阶段）。在家庭研究第2和第3阶段，将提供作为愉悦活动的体育锻炼计划的健身游戏（用于体育锻炼的严肃游戏）发送到患者私人家庭，并在方案的最后阶段（家庭研究第3阶段）实施电子辅导技术，以影响患者对更健康和推荐生活方式的态度。
试验仍在进行中。招募工作正在进行，该项目对一些参与者已推进到家庭研究的第2阶段。两项研究的样本量均为28名参与者；已有10名纳入研究，且已获取基线临床和患者报告的结局数据。家庭预试验研究的第2和第3阶段预计在6个月内完成。
该项目的主要挑战是通过电子辅导系统改变老年心力衰竭患者的态度。鉴于采用了共同创造和生活实验室方法以及实际生活评估的主要目标，该项目随时准备对任何收集到的反馈做出反应，即使在研究计划实施期间。临床评估和客观评价有望为可靠的研究结果提供所有所需信息。
ClinicalTrials.gov NCT03877328；https://clinicaltrials.gov/ct2/show/NCT03877328。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/17714。
