Jia Ying Ying, Dong Ming Qi, Feng Jia, Hu Jing Ni, Hu Huan Ting, Yuan Tian Man, Song Jian Ping
Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China; Nursing Department, Zhejiang University School of Medicine, Hangzhou, 310000, China.
School of Nursing, Zibo Vocational Institute, Zibo, 255000, China.
Curr Probl Cardiol. 2025 Mar;50(3):102967. doi: 10.1016/j.cpcardiol.2024.102967. Epub 2024 Dec 8.
Patients with poor prognosis after TAVR surgery require high-quality cardiac rehabilitation. Digital home-based rehabilitation based on real-time information intervention can improve outcomes. However, the parameters of the text message intervention, such as text message content, intervention duration, text message frequency, and other parameters, may vary.
This is an evaluator-blinded randomized controlled trial. TAVR patients will be recruited from the cardiology intensive care unit of a hospital and randomly assigned to either the control group or the experimental group. The control group will receive standard cardiac rehabilitation, while the experimental group will receive instant message rehabilitation intervention over six months in addition to the standard care. The primary outcomes are home-based cardiac rehabilitation adherence and six-minute walk distance. Secondary outcomes include quality of life, frailty, activities of daily living scale scores, incidence of adverse events, death during follow-up, NYHA functional classification, readmission rate, and length of hospital stay. Data will be collected at three time points: baseline, three months after intervention, and six months after intervention. Generalized equation assessment will be used to evaluate the effectiveness of the instant message intervention.
Using behavior change theory as the overall framework, guided by behavior change techniques and based on evidence-based medicine, the digital HBCR intervention program that can be implemented by caregivers has been designed. If the intervention proves effective, it will promote the development of home-based rehabilitation for TAVR patients.
NCT06418555.
经导管主动脉瓣置换术（TAVR）后预后较差的患者需要高质量的心脏康复治疗。基于实时信息干预的数字化家庭康复可改善治疗效果。然而，短信干预的参数，如短信内容、干预时长、短信频率等参数可能各不相同。
这是一项评估者盲法随机对照试验。将从一家医院的心脏重症监护病房招募TAVR患者，并随机分配至对照组或试验组。对照组将接受标准心脏康复治疗，而试验组除接受标准治疗外，还将在六个月内接受即时消息康复干预。主要结局指标为家庭心脏康复依从性和六分钟步行距离。次要结局指标包括生活质量、衰弱程度、日常生活活动量表评分、不良事件发生率、随访期间死亡率、纽约心脏协会（NYHA）功能分级、再入院率和住院时间。将在三个时间点收集数据：基线、干预后三个月和干预后六个月。将使用广义方程评估来评价即时消息干预的效果。
以行为改变理论为总体框架，以行为改变技术为指导，并基于循证医学，设计了可由照护者实施的数字化家庭心脏康复（HBCR）干预方案。如果干预被证明有效，将推动TAVR患者家庭康复的发展。
NCT06418555。
