Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone?
研究概览
简要总结
Training patients to alter their own therapy early in the course of a developing exacerbation (self-management) has been shown to improve outcomes in asthma, but there is no good evidence on this for patients with Chronic Obstructive Pulmonary Disease (COPD). Case management, with patients having an identified contact who helps them access care when necessary, has been shown to improve outcomes in recent studies. A combined approach, called supported selfmanagement, may be particularly suitable for this socially and often educationally disadvantaged group of patients.We propose to identify 500 patients at the time of an exacerbation to test this combined strategy in a randomised manner. The primary outcome measure will be readmission to hospital or death due to COPD, important in terms of patient preferences, quality of life and health costs. This will provide important information about intermediate care for COPD patients which should influence service provision within the NHS in Scotland
详细描述
There have been no randomised controlled trials from UK settings reporting either the effect or the costs of an intensive, individualised case- and self-management intervention for patients with COPD. Given new evidence from other countries (discussed above), we propose that a combined case- and self-management (henceforth referred to as "supported self-management") intervention is most likely to produce measurable benefits from this socially and physically disadvantaged group of patients. Supported self-management involves:
- Individualised self-management education, delivered in the patient's own home at fortnightly intervals over a two-month period with monthly telephone follow-up. This component of the intervention is based on an intervention shown to be effective in Canada. It is based on the principle of empowering patients to manage their COPD themselves more effectively by improving disease understanding and symptom monitoring, and improving patients' confidence to carry out appropriate action, such as altering therapy early on in the evolution of an exacerbation or initiating contact with a named professional for telephone advice, a home visit or further hospital care (case management) as and when required. We believe home visits are critical to the success of this intervention as this group of breathless and disabled patients often default from clinics and rehabilitation attendance on account of exacerbations or breathlessness.
- To maintain the impact of self-management training, a named nurse will visit the patient at (a maximum interval of) six-weeks to reinforce self-management messages; this nurse will also be contactable by the patient, as required, prompting an earlier home visit, or GP or hospital attendance as appropriate.
This supported self-management approach (intervention group) will be compared with standard care (control group).
Aim: To address, via a prospective randomised controlled trial in Glasgow, whether supported self-management, in addition to usual care, in patients with moderate to severe COPD has a measurable benefit on patient morbidity and mortality compared to usual care.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recent hospital admission with exacerbation
- •normal cognitive function (MMSE of 9 or 10)
排除标准
- •malignancy
结局指标
主要结局
Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone?
时间窗: 1 year
次要结局
- Difference in mean St George Respiratory Questionnaire (SGRQ) scores and the proportion of patients achieving a 4-point improvement in SGRQ mean score at 6 months and 1 year between the intervention and control groups?(1 year)
- Difference in length of hospital stay (all causes and sub classified by principle diagnosis)(1 year)
- Do demographic variables such as age, sex and social class impact on patient ability to self-manage on the basis of recognising and responding appropriately to worsening symptoms?(i year)
- Can nurse assistants deliver the combined self- and case-management intervention as effectively as staff nurses, measured by analysis of the appropriateness of behavioural changes in response to worsening symptoms?(1year)
- Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group.(1 year)