Glasgow Supported Self Management Trial (GSuST) — GSuST  

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title: Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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:

1. 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.

2. 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT00706303
• Study type: Interventional
• Source: NHS Greater Glasgow and Clyde
• Contact: Christine E Bucknall, MD
• Phone: 44-141-201-3717
• Email: christine.bucknall@ggc.scot.nhs.uk
• Status: Recruiting
• Phase: N/A
• Start date: June 2007
• Completion date: December 2009