Evalutation of a Hybrid Care Pathway With Remote MONitoring for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 7
- 主要终点
- Number of days spent out of hospital within one year
研究概览
简要总结
Heart failure is a long-term condition in which the heart cannot pump blood as well as it should. People with heart failure often need to be admitted to hospital when their symptoms suddenly get worse, which affects their quality of life and places a heavy burden on the healthcare system.
In recent years, hospitals have started using home telemonitoring, in which patients measure values such as their weight, blood pressure, heart rate, and symptoms at home every day. These measurements are sent to a Medical Service Center (MSC), who can step in quickly when early warning signs appear - often before the patient feels seriously unwell.
The HARMONY-HF study looks at how well this hybrid care pathway works in everyday practice. The researchers will compare heart failure patients who take part in the home telemonitoring programme with patients who receive usual care without telemonitoring, across seven hospitals in the Netherlands. Because all care is part of routine treatment, patients are not asked to do anything extra for the study; the researchers use information that is already collected during normal care.
The main goal is to find out whether patients in the telemonitoring programme spend more days at home and out of the hospital. The study also looks at survival, hospital admissions, quality of life, and the use of recommended heart failure medication. The findings will help determine whether this approach should be offered more widely.
详细描述
The HARMONY-HF study is a real-world, multicentre, observational cohort study with both retrospective and prospective components.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adults (at least 18 years or older)
- •Diagnosed with heart failure according the prevailling ESC guideline
- •Treatment at the outpatient clinic at one of the seven participating hospitals
- •Sufficient digital literacy and adequate Dutch language proficiency by the patient or throught the informal caregiver.
排除标准
- •Inability or unwillingness to participate in home telemonitoring
- •Patients with end-stage heart failure or other terminal conditions
结局指标
主要结局
Number of days spent out of hospital within one year
时间窗: From enrollment to the end of follow-up at 400 days after inclusion
For each patient, follow-up time is calculated from the inclusion date until the earliest of the following: the end of the 400-day analysis period, death, or the last known date of contact (i.e., loss to follow-up). The number of days without hospitalisation is derived by subtracting the number of unplanned in-hospital days from each patient's accumulated person-time. By censoring follow-up at the date of death, person-time reflects only the period during which a patient was actually observed and at risk, thereby accounting for the competing risk of mortality. Although the primary outcome concerns the first year of follow-up, the analysis period is defined as the first 400 days after the inclusion date rather than exactly 365 days. In routine clinical practice, it is not always possible for a patient to attend an outpatient contact precisely 365 days after the start date. A modest margin is incorporated around the one-year mark, thereby maximising the proportion of complete follow-up.
次要结局
- All-cause survival(From enrollment to the end of follow-up at 400 days after inclusion)
- HF-related survival(From enrollment to the end of follow-up at 400 days after inclusion)
- Health-related quality of life (KCCQ-12)(Baseline, 3 months, 6 months and 12 months)
- Healthcare utalisation and associated costs(From enrollment to the end of follow-up at 400 days after inclusion)
- Guideline-Directed Medical Treatment (GMDT) scores(Baseline, 6 weeks, 3 months, 6 months and 12 months)
研究者
B.T.G. Köhlen
Coordinating investigator
St. Antonius Hospital