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临床试验/NCT00129987
NCT00129987已完成不适用

A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma

Imperial College London1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2003年11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
567
试验地点
1
主要终点
Number of Participants With Unscheduled Use of Healthcare

研究概览

简要总结

Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.

详细描述

This study will be a randomised controlled trial looking for equivalence; the investigators' central hypothesis is that lay-led education will be at least equivalent to professional-led education in terms of patient outcomes. Patients will be randomised to receive either lay-led or professional led self-management education. Patients will be followed up longitudinally for 12 months from initial intervention. Two sites were studied; Manchester and London. It is anticipated that 16 sites will be recruited in each of the two geographical areas; all sites will have an asthma register. Individuals will be eligible for inclusion if they are adults; have clinician diagnosed asthma; have persistent disease and require regular therapy, with some evidence of variability in their disease, such that a self management plan would be appropriate. Both genders will be eligible, as will those unable to see or read. Individuals will be excluded if they have severe cognitive impairment; they decline to be randomised; they decline to receive asthma education and follow-up solely from the designated educator, other than in an emergency situation, or their condition does not show variability.

The intervention in the study will be a disease-specific asthma self-management education programme delivery either by a professional (ie practice nurse) or a lay educator. Both lay and professional trainers will receive specific training in the content and delivery of this intervention. The intervention will consist of an initial 45 minute training session (including receipt of a written personal asthma action plan); a second face to face reinforcing session 3 weeks after the first session; 3 monthly telephone follow-up appointments to reinforce messages and to give ongoing advice with availability of the nurse or lay educator as a source of advice at all other times. Data will be collected on unscheduled use of health care, peak flow readings, patients' self-reporting of "adverse events", RCP three questions, perceptions of the interviews using MISS-21, QOL questionnaire and AQLQ. Demographics for all patients will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults step two therapy (BTS)
  • •Evidence of poorly controlled disease

排除标准

  • •Unable to benefit from self management education
  • •Other respiratory conditions other than asthma

研究组 & 干预措施

Nurse group

Experimental

An initial consultation of up to 45 min offered either by a practice based primary care nurse, followed by a second shorter face to face consultation and telephone follow-up for 1 year.

干预措施: Self management education (Behavioral)

Lay educator group

Experimental

An initial consultation of up to 45 min offered either by a lay educator, followed by a second shorter face to face consultation and telephone follow-up for 1 year.

干预措施: Self management education (Behavioral)

结局指标

主要结局

Number of Participants With Unscheduled Use of Healthcare

时间窗: 1 year

Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP

次要结局

  • Number of Participants With Use of Asthma Medication(1 year)
  • Lung Function(1 year)
  • Quality of Life Questionnaires(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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