Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease. A Clinical, Randomized, Controlled Study for Evaluation of Clinical and Economic Consequences of Monitoring Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of hospitalization days
研究概览
简要总结
The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.
详细描述
Telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (COPD) disease. Telemedicine, for monitoring disease exacerbation, is the focus area of our research. The patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of COPD exacerbation or pulmonary infection. The self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. After one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. With the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. Data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. The selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. All patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. It is expected that the monitoring of symptoms and signs will support patient empowerment.
The investigation is planned to assess the clinical and economic effects of the intervention.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Obstructive Pulmonary Disease COPD with FEV1/FVC (Forced Expiratory Volume in 1 second / Forced Vital Capacity) below 70% at all times during the study. FEV1 below 51% during inclusion and during the further study. Inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms.
排除标准
- •Not able to give written or oral consent
- •Terminal disease, such as cancer
- •Unstable heart disease, such as coronary infarction within the last to month
- •Disabling psychiatric disease
- •Inability to use the equipment
- •Severe language barriers
- •Drug abuse
- •Alcohol abuse
研究组 & 干预措施
Control
Best practice
Intervention
Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device.
干预措施: Tele Monitoring, using Tunstall monitoring device (Device)
结局指标
主要结局
Number of hospitalization days
时间窗: During twelve months
次要结局
- Duration of COPD related hospitalizations, in days(Twelve months)
- Sensitivity of physiological measurements in detecting COPD exacerbation(During six months of intervention)
- Number of unplanned contact to primary health sector(Twelve months)
- Health related quality of life(Twelve months)
- Number of hospitalizations caused by COPD exacerbation(During twelve months)
- Number of self-addressed COPD exacerbations(Twelve months)
- Number of COPD related contacts to emergency rooms(Twelve months)
- Number of all cause contacts to primary health sector(Twelve months)
- Mortality(During twelve months)
