European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 409
- 试验地点
- 22
- 主要终点
- Euro spent to follow up ICD and CRT-D patients
研究概览
简要总结
BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer.
The EuroEco study:
- Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service.
- Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
- Compares the indicators of patients' safety between the two FU models.
详细描述
The EuroEco is a prospective, international, randomized study aimed at assessing the economic effects of BIOTRONIK Home Monitoring (HM) technology as compared with traditional follow up (FU) of ICD and CRT-D patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on the physician, hospital and patient. The study outlines a new model for the FU of ICD-and CRT-D patients based on a combination of in-clinic consultations and regular check ups of the patient data received through the HM service.
About 312 patients with an indication for ICD therapy and 104 patients with an indication for de novo CRT-D implantation should be enrolled. All patients will be implanted with BIOTRONIK ICD or CRT-D devices from the Lumax families and randomized (1:1) to the traditional, or to HM-based FU model. Traditional FU will be performed according to the local clinical practice. Patients in the HM study arm will first undergo local clinical FU routine until the first in-clinic visit after patient discharge. Thereafter routine in-clinic FUs are scheduled at 12 and 24 months. Three HM data checks should be carried out during each 12-month interval, to assess the patient/ICD/CRT-D status remotely.
In both (HM and no HM) groups, additional in-hospital FU may be scheduled any time the patients reports symptoms which are presumed to be cardiovascular symptoms. In the HM group, additional in-clinic FU may also be scheduled as a result of specific HM findings.
The following FU-related activities were accounted for: in-clinic consultations, patients contact, discussion with colleague physician, nurse or technician and arranging in clinic consultation. In HM patients, two additional HM-related FU activities were taken into account: 1) checking the website of BIOTRONIK HM Service Center, and 2) checking HM-related emails and faxes (provided by BIOTRONIK HM Service Center)..
Several tools were made available to document the time that physicians, nurses and technicians spend with these FU activities without disrupting their clinical routine much:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
HM ON vs. HM OFF
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Euro spent to follow up ICD and CRT-D patients
时间窗: 26 months
次要结局
- Average number of in-hospital follow-up visits per patient(26 months)
- Time to first in-hospital follow-up visit beyond the first post-implantation visit(12 months)
- Effective financial impact on hospitals / physicians(26 months)
- Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)(26 months)
- Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up(26 months)
- Incidence of inappropriate ICD shocks(26 months)
- Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits(26 months)