Early Assisted Discharge With Generic Community Nursing and Pulmonary Physicians vs Telemonitoring at Home for Chronic Obstructive Pulmonary Disease Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Time Until the First Exacerbation
研究概览
简要总结
To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.
详细描述
This study seeks to improve the health of patients with AECOPD by home care after discharge from the Hospital using the technology of the information and the communication. The investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with AECOPD with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the hospital with COPD exacerbation
- •No concomitant serious unstable diseases
- •Without fever in 48 hours
- •Aerosol treatment at the most every 6 hours
- •Treatment with glucocorticoid intravenous < 40 mg twice a day
- •A thoracic radiograph without new disease
- •Subjective improvement of the patient
- •Familiar suitable environment
排除标准
- •Neoplasias and other chronic diseases in terminal situation
- •Alcoholism
- •Intravenous medication
- •Disability to understand and take part in the program
- •Admitted to intensive care unit (ICU) or non invasive mechanical ventilation during the exacerbation
- •Unstability hemodynamic
- •To be an institutionalized patient.
结局指标
主要结局
Time Until the First Exacerbation
时间窗: Change from stable to exacerbation the first time at 6 month
Time until the first exacerbation is the time that patient is stable before a new exacerbation and meaning a good control of the disease.
次要结局
- SATISFAD 10(Participants will be followed for the duration home care, an expected average of 7 days)
- State-Trait Anxiety Inventory (STAI)(Participants will be followed for the duration of home care, an expected average of 7 days)
- Percentage of Participants With Medication Adherence Assessed Using Morinsky-Green-Levine Test(Participants will be followed for the duration of home care up 24 weeks)
- Monitoring Compliance(Participants will be followed for the duration of home care, an expected average of 7 days)
- Number of Home Visits(Participants will be followed for the duration of home care, an expected average of 7 days)
- COPD Assessment Test (CAT)(Participants will be followed for the duration of home care and up to 4 weeks)
研究者
Dr. López Viña
Investigator
Puerta de Hierro University Hospital