跳至主要内容
临床试验/NCT01178879
NCT01178879已完成不适用

Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
1
主要终点
The number of readmissions

研究概览

简要总结

The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.

详细描述

COPD is among the most common reasons for illness and fatality in adults worldwide, and it is expected that this trend will escalate radically by 2020 (1). Approximately 29% of patients admitted to Hospital with exacerbation will be readmitted within the first month (2), and after one year 46% of patients will have been readmitted on one or more occasions due to exacerbation (3).

Therefore, trials have been carried out using different forms of digitally supported distance health interventions (telehealth nurse consultations) (4) of patients with COPD with a view to reducing the number of readmissions in a reliable way, measured in relation to mortality. Thus in these trials there are a certain indication that use of telehealth nurse consultations of patients with COPD is a treatment initiative that reliably can reduce the number of COPD patients readmitted with exacerbation.

The number of randomized telehealth studies are however few (4;5), and there is a lack of documentation of the effect of telehealth monitoring.

Therefore, a large randomized telehealth study with a clear set up was necessary.

This study is a randomized multicenter trial that will take place at the acute admissions department and lung department at Odense University Hospital,Denmark

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
Single (Outcomes Assessor)

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) verified by spirometry.
  • •Exacerbation in COPD, defined as increased need for medicine, and increased dyspnea or increased expectorate or increased coughing.
  • •> or 40 years old
  • •Living on Funen and islands
  • •Signed informed consent.

排除标准

  • •Not able to communicate via telephone and/or computer screen
  • •Previously received "The COPD suitcase", or participated in this protocol
  • •Systolic BT is <100 mm Hg
  • •Saturation < 90
  • •Thorax x-ray shows signs of malignant changes or lobar pneumonia
  • •Diagnosed with cancer or recurrence of cancer within the last five years
  • •Admitted with septic shock, acute myocardial infarction or other serious medical condition (for example renal disease)
  • •Diagnosed with heart failure (EF < 30%)
  • •Refused to participate

研究组 & 干预措施

Telehealth consultation

Experimental

Telehealth nurse consultation plus treatment as usual

干预措施: Telehealth consultation (Behavioral)

Conventional

No Intervention

Treatment as usual

结局指标

主要结局

The number of readmissions

时间窗: at 26 weeks after discharge

次要结局

  • The number of hospital readmissions with exacerbation(at 26 weeks after discharge)
  • The duration to the first readmission(at 26 weeks after discharge)
  • The number of days readmitted(days 26 weeks after discharge)
  • The mortality rate(at 26 weeks weeks after discharge)
  • The number of days readmitted with exacerbation(days 26 weeks after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Birte Oestergaard

Associate professor

University of Southern Denmark

研究点 (1)

Loading locations...

相似试验

Randomised Trial of Telehealth Consultations for... | 临床试验