The Impact of Comprehensive Post Hospital Management Based on Digital Health Intervention on Cardiac Function in Patients With Heart Failure: a Prospective, Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.
This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDS™) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized for HF, NYHA classification II-IV upon admission
- •The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic
- •No difficulty using smartphones, with basic Chinese reading and writing skills
- •Accept the terms and conditions of the study and obtain informed consent from the subjects/their families
排除标准
- •Age<21 years old
- •Patients with height<155 cm or>190 cm, BMI<22 kg/m2 or>36 kg/m2, chest circumference<80 cm or>115 cm, and flail chest or rib fractures
- •History of pulmonary embolism
- •chronic renal failure（Scr > 443umol/L）
- •History of heart transplantation or pacemaker implantation
- •Severe pulmonary hypertension
- •Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
- •Massive pleural effusion
- •The subject is unable to complete the 6-minute walking test
- •Expected lifespan<6 months
- •Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
- •Individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses)
- •Currently participating in clinical trials of other devices or drugs
- •Researchers involved in the design and execution of this study
研究组 & 干预措施
Routine Management Group
The routine management group will accept the routine HF management of SOC throughout the course, and the doctor will carry out treatment and management according to the actual clinical situation, including pre discharge education, precautions for commonly used drugs, guidance for daily life activities, etc.
Comprehensive post hospital management group
Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc.
干预措施: Comprehensive post hospital management based on digital health intervention(DHI) (Other)
结局指标
主要结局
6-minute walk test
时间窗: The 6th month after discharge
Improvement in 6-minute walk test after discharge for 6 months
次要结局
- Quality of life index (QLI) rating(The 1st ,3rd and 6th months after discharge)
- Kansas city cardiomyopathy questionnaire (KCCQ-23) rating(The 1st ,3rd and 6th months after discharge)
- NYHA classification(The 1st ,3rd and 6th months after discharge)
- Left ventricular ejection fraction (LVEF)(The 6th month after discharge)
- Number of readmissions for heart failure(Within 6 months after discharge)
- All-cause mortality(Within 6 months after discharge)
- Composite endpoint of all-cause death or readmission due to heart failure(Within 6 months after discharge)
- Time to first hospitalization for heart failure from baseline(Within 6 months after discharge)
- Cardiac death(Within 6 months after discharge)
研究者
Yu Bo
Chief Physician
Harbin Medical University