Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Health care costs
研究概览
简要总结
The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are:
- Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure?
- Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients?
- Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team.
Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.
- •Admitted for decompensation of chronic HF.
- •Admitted for HF decompensation ≥30 days and ≤6 months.
- •HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or >50% increase in loop diuretic dose.
- •With previous optimized prognostic medical treatment.
- •Under treatment with loop diuretic drugs.
- •New York Heart Association functional class II, III or IV.
排除标准
- •Inclusion in other intervention studies.
- •Hemodynamic instability.
- •Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days.
- •Uncontrolled arrhythmias
- •On waiting list for transplantation (any organ) or other cardiac surgery.
- •Advanced mechanical circulatory support.
- •Chronic renal disease on hemodialysis.
- •Life expectancy less than 1 year.
- •Moderate-severe cognitive impairment.
- •Manifest inability to use a technological system.
- •Institutionalized.
- •Limiting psychiatric pathology.
研究组 & 干预措施
Telemonitoring group
Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.
干预措施: Telemonitoring follow-up using medical devices and telematic consultations (Other)
Control gropu
Usual care follow-up group
结局指标
主要结局
Health care costs
时间窗: 12 months
Sum of the costs for the consumption of medicines, primary care consultations, specialist consultations, hospitalization, emergency care and medical transport.
次要结局
- Non-health care costs(12 months)
- Symptoms(12 months)
- Number of hospital admissions(12 months)
- Mortality(12 months)
- Care burden of caregivers(12 months)
- Patient satisfaction with service(12 months)
- Adherence to the telemonitoring protocolo(12 months)
- Quality of life variation(12 months)
研究者
Juan Carlos López-Azor
Principal Investigator, Doctor in Medicine
Hospital Universitario 12 de Octubre