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临床试验/NCT02321215
NCT02321215已完成不适用

Effectiveness and Feasibility of Delivering an Introductory Education Program to Patients Admitted to Hospital With an Acute Exacerbation of COPD - a Pilot Randomized Controlled Trial

West Park Healthcare Centre1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年1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
31
试验地点
1
主要终点
Change from baseline in information needs

研究概览

简要总结

The purpose of this study is to determine if it is effective and feasible to provide a chronic obstructive pulmonary disease (COPD) education program to patients admitted with an acute exacerbation of COPD.

详细描述

Following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) evidence strongly suggests that all patients should be discharged with an action plan, consisting of identified patient responsibilities for their ongoing care and advice on recognizing and seeking help in the event of future acute exacerbations. Despite these recommendations, structured chronic obstructive pulmonary disease (COPD) specific education is rarely offered within acute hospital settings and, in addition, research in this area is limited. This study aims to determine the effectiveness and feasibility of an introductory education program delivered during and shortly after an AECOPD hospitalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •medically confirmed diagnosis of AECOPD (alone or combined with other conditions)
  • •capable of understanding the study information and giving informed consent

排除标准

  • •admitted due to lung diseases other than COPD
  • •received COPD education in the previous 6 months (in primary care, acute or rehabilitation hospitals)
  • •presence of diagnosis of dementia or incapacity to learn due to cognitive issues
  • •have medical, cognitive or language limitations to communicating in written or spoken English
  • •have participated or been asked to participate in the trial before
  • •in the intensive care unit

研究组 & 干预措施

Control

No Intervention

Usual care: This group will receive usual care from their physician without any special focus on education. At the end of the study period, patients that were assigned to the control group will receive the booklet at home and be offered two education sessions by phone or in-person if the patient is willing to return to the hospital.

Education Intervention

Active Comparator

Introductory disease education: This group will attend two one-on-one education sessions. The educational content will be standardized and a checklist will be used to ensure that all topics are addressed. The sessions will focus on enhancing self-efficacy in areas that are thought to be important to individuals who recently had an AECOPD.

干预措施: Introductory Disease Education (Other)

结局指标

主要结局

Change from baseline in information needs

时间窗: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission

Lung Information Needs Questionnaire (LINQ)

Change from baseline in disease specific knowledge

时间窗: This primary outcome measure will be collected prior to randomization and approximately four weeks after admission

Bristol COPD Knowledge Questionnaire (BCKQ)

次要结局

  • Feasibility measure: number of eligible patients(This outcome variable will be noted within 1-2 days of hospital admission with an AECOPD (when determining patient eligibility, before randomization).)
  • Feasibility measure: ease of recruiting patients(This outcome variable will be noted within 1-2 days of hospitalization, while the patient is being recruited (before randomization).)
  • Feasibility measure: compliance to the sessions(This outcome measure will be noted after each education session. The education sessions will take place between 3-15 days after hospital admission for an AECOPD. Two education sessions will be delivered to every patient enrolled in the intervention arm.)
  • Feasibility measure: follow-up rates(This outcome variable will be noted between days 20-30 following admission to hospital (approximately four weeks after hospital admission).)

研究者

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

Tania Janaudis Ferreira

Scientist

West Park Healthcare Centre

研究点 (1)

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