Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
研究概览
简要总结
Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.
详细描述
Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring.
The specific aims of the study are:
- To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure.
- To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program.
This is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, there is no upper age limit
- •Diagnosed with heart failure regardless of left ventricular ejection fraction
- •Having New York Heart Association (NYHA) Class III/IV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months
- •Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg/ml for patients under 50 years; (b) ≥900 pg/ml for patients aged 50-75 years; (c) ≥1800 pg/ml for patients over 75 years.
排除标准
- •Life expectancy <6 months
- •Physical characteristics that prevented use of the ReDS (body mass index < 22 or >39, and height less than 155 cm or higher than 195 cm)
- •Implantation of a left ventricular assist device or cardiac transplantation.
结局指标
主要结局
Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death
时间窗: 3 months
次要结局
- Total number of acute healthcare visits for heart failure(1 month, 3 months and 6 months)
- Total number of unplanned hospitalisations for heart failure(1 month, 3 months and 6 months)
- Total number of all-cause death(1 month, 3 months and 6 months)
- Number of days alive out of hospital(1 month, 3 months and 6 months)
- Changes in NT-proBNP/BNP levels(Baseline, 3 months and 6 months)
- Changes in the remote dielectric sensing (ReDS) values(Baseline, 3 months and 6 months)
- Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores(Baseline, 1 month, 3 months and 6 months)
- Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores(Baseline, 1 month, 3 months and 6 months)
- Changes in the heart failrue self-care behaviour scores(Baseline, 1 month, 3 months and 6 months)
研究者
Naoko Perkiö Kato
Associate Professor
Linkoeping University