Consecutive, Randomized Controlled Multicenter Trial, Investigating the Feasibility and Safety of a Telemedicine Based Treatment Regimen in Patients With Chronic Obstructive Pulmonary Disease (COPD), Compared to Conventional Hospital Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Death
研究概览
简要总结
Introduction:
With the rapid development in technology telemedicine has become a tool with the potential to improve and optimize the treatment of different diseases and to make diagnostics, treatment and counseling possible over shorter or longer distances.
Home based telemedicine is a new method that leads to a series of important questions that needs to be answered. This study is designed to answer questions concerning patient safety in telehomecare, the patients´ quality of life, efficiency and a cost benefit analysis of implementing this technology.
This study is about patients with chronic obstructive pulmonary disease (COPD) who are admitted to the hospital with an acute exacerbation. Approximately 24 hours after admission half of the patients are randomized to be admitted to their own home supported by telemedical equipment while the other half remain admitted at the hospital (typically between 5-7 days).
Primary Aim:
To investigate if telemedical surveillance and treatment in the recovery period of an acute exacerbation is just as safe as conventional admission of patients with COPD measured on treatment failure.
Secondary Aims:
To evaluate if telemedical surveillance and treatment in the recovery period of an acute exacerbation compared to conventional treatment of COPD:
- Is comparable in reestablishing Forced Expiratory Volume in 1 second (FEV1).
- Demands the same number of treatment days/time before discharge/cessation of telemedical surveillance.
- Is comparable in quality of life in the two groups of treated patients.
- Have comparable adverse event profiles.
- leads to a lower total cost in health services (health economical analysis)
- Is possible to do for the patients (drop-outs because of the technical equipment or the patient does not know how to use the equipment.)
7 Is better seen from the physician's perspective when it comes to:
- The virtual patient contact / communication
- Technology
- The work process compared to the conventional work process
- Time spent with the patient
- Usability
- Improvement potentials ("the doctors view")
8. The equipment is satisfactory for the patient to use
Method
For this study a telemedical platform has been developed on which it is possible to treat patients in their own homes. The platform consists of a videoconference part that allows the patients to make contact to qualified medical staff and a technology part that can transfer vital indicators of the patients´ health condition (lung function, oxygen saturation, pulse etc.) 175 patients will be included with an expected drop-out of 20 % or 35 patients. The patients will be equally recruited from two hospitals (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their COPD that requires hospitalization to be included in this study. Each patient participates in the study for 6 months after discharge with follow-up at 1, 3 and 6 months.
详细描述
In addition to the main study, two sub studies will be conducted, using the same intervention and subjects as the main study;
- COPD patients´ self-efficacy after virtual admission compared to hospital admission - implications for clinical practice
- Cognitive function and daily life after virtual admission compared to conventional hospital admission in patients with chronic obstructive pulmonary disease (COPD)
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Ad. 1: COPD patients´ self-efficacy after virtual admission compared to hospital admission - implications for clinical practice
Background:
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
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD stage III or IV according to GOLD guidelines
- •>45 years of age
- •Compliant patient (is able to see, hear and follow instructions)
- •Estimated admission time > 2 days
排除标准
- •X-score > 4 at randomization(need of NIV or respirator)
- •severe overweight assessed by investigator
- •serious comorbidity (malignancy,unstable heart disease, dysregulated diabetes or other disease that makes participation impossible)
- •non-compliant patient (cannot follow simple instructions)
- •fever (>38 degrees Celsius) at randomization point, in need of I.V. antibiotics assessed by investigator
- •participation in another clinical trial within the last 30 days
研究组 & 干预措施
control
The control group will receive usual care and treatment at the hospital until discharge(typically between 5-7 days).
telemedicine
Within 24 hours after admission for exacerbation of COPD, patients in the intervention group are sent home for further treatment (telemedicine based) instead of the conventional treatment at the hospital. Patients in the intervention group will receive the same treatment as the control group and have daily contact with the physician/nurse at the hospital through a videoconference system.
干预措施: Telemedical admission and treatment in the patients´ own homes instead of conventional admission and treatment at the hospital (Other)
结局指标
主要结局
Death
时间窗: 30 days, 3 months, 6 months
To study essential safety parameters for the patients the numbers of deaths will be compared in the two groups using data from the Danish Death Registry.
readmission
时间窗: 30 days, 3 months, 6 months
Readmission can be considered as a treatment failure related to COPD and will thus be assessed in both groups by reviewing the hospital patient administration system.
need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator)
时间窗: 30 days, 3 months, 6 months
Self-efficacy
时间窗: 3 days
Self-efficacy is measured using "The COPD self-efficacy scale". The scale has been validated in Danish, prior to its use in the current sub studies. The patients will be asked to fill in the questionnaire at baseline, and 3 days after discharge
Cognitive function
时间窗: 3 days and six weeks after discharge
Cognitive function evaluated by a neuropsychological test battery, International Study of Post Operative Cognitive Dysfunction (ISPOCD) including verbal learning, memory capacity and attention.
次要结局
- Patient satisfaction(30 days)
- Healthrelated Quality of life(baseline, discharge, 4-6 weeks, 3 months, 6 months)
- Health related quality of life(3 days, 6 weeks, 3 months after discharge)
- FEV1(30 days, 3 months, 6 months)
- Adverse event(30 days)
- Physicians/user satisfaction(30 days)
- Number of bed days(30 days)
- Activities of daily living(3 days, six weeks and three months after discharge)
- Admission days(30 days)
- cost in health services(30 days, 3 months, 6 months)
- Telemedicine coping skills(30 days)
- Self-reported cognitive function(3 days, six weeks and three months after discharge)
- Self-efficacy(up to 3 months)
- Anxiety and Depression(3 days, six weeks and three months after discharge)
研究者
Klaus Phanareth
MD, ph.d, research leader
Frederiksberg University Hospital