Efficiency of a Clinical Process Based on Remote Review of Symptoms in Patients With an Implantable Diagnostic Holter.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- TIME FRAME
研究概览
简要总结
To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
详细描述
Population of patients: Patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period.
Design: Clinical, randomized, prospective, single-center study.
Investigational Device: BIOMONITOR III implantable cardiac holter and successive models with HOMEMONITORING remote monitoring system for constant monitoring of patient's cardiac signals. Installation of the Patient APP on the patient's phone for symptom transmission.
Overall Objective: To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection)
- •Patients over 18 years old.
- •Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms.
- •Patients capable of using the patient application.
排除标准
- •Patients over 80 years of age or, failing that, not able to use an application to send their symptoms.
- •Life expectancy of less than 12 months for any reason.
结局指标
主要结局
TIME FRAME
时间窗: one year
Time from the first alert by Home Monitoring of the implantable holter to the clinical diagnosis according to the patient's clinical indication.
次要结局
- Number of in-person visits in each group(one year)
- Rate of false positives(one year)
- Rate of symptoms sent by the patient(one year)
- Rate of symptoms sent by the patient that correspond to remote alerts sent by the patient(one year)
- Rate of symptoms not corresponding to detected arrhythmias(one year)
- Incidence remote transmissions activated by patient indication(one year)
- Number of new non-cardiac clinical diagnoses discovered thanks to the symptoms sent by the patient.(one year)
- Efficacy of implementing a clinical process based on remote monitoring of patient symptoms(one year)
- Qualitative Patient Objectives(one year)
研究者
Andres Iñiguez Romo
Head of Cardiology
Fundacin Biomedica Galicia Sur