Glasgow Supported Self Management Trial (GSuST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by NHS Greater Glasgow and Clyde.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00706303
First received: June 25, 2008
Last updated: June 26, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: Supported self management training and support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • 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? [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Difference in length of hospital stay (all causes and sub classified by principle diagnosis) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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? [ Time Frame: i year ] [ Designated as safety issue: No ]
  • 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? [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Intervention group
Supported Self-management. This will consist of fortnightly individual patient sessions at home of approximately 40 minutes for two months, with home visits at a maximum frequency of 6 weeks thereafter for 1 year. Follow up visits will be less structured, and based on the patient's individual agenda as well as reviewing and reinforcing basic self-management messages. Patients will be provided with an individualised self-management plan and symptom diary cards to use as a monitoring aid. Patients will be trained to identify and treat exacerbations associated with purulent sputum with antibiotic and those associated with increased breathlessness, mucoid sputum and/or upper airway symptoms with Prednisolone.
Behavioral: Supported self management training and support
Supported Self-management. This will consist of fortnightly individual patient sessions at home of approximately 40 minutes for two months, with home visits at a maximum frequency of 6 weeks thereafter for 1 year. Further details of the rubric of the initial training sessions are given in Appendix 1 and will use adapted versions of the Bourbeau self-management and education materials. Follow up visits will be less structured, and based on the patient's individual agenda as well as reviewing and reinforcing basic self-management messages. Patients will be provided with an individualised self-management plan and symptom diary cards to use as a monitoring aid. Patients will be trained to identify and treat exacerbations associated with purulent sputum with antibiotic and those associated with increased breathlessness, mucoid sputum and/or upper airway symptoms with Prednisolone.
No Intervention: 2
Usual care. The control group will receive usual care, as decided by their GP and or hospital consultant, and the patient themselves (e.g., NHS 24 helpline). They will be asked to complete diary cards and receive telephone follow up calls as an attention control, similar to the intervention group.
Behavioral: Supported self management training and support
Supported Self-management. This will consist of fortnightly individual patient sessions at home of approximately 40 minutes for two months, with home visits at a maximum frequency of 6 weeks thereafter for 1 year. Further details of the rubric of the initial training sessions are given in Appendix 1 and will use adapted versions of the Bourbeau self-management and education materials. Follow up visits will be less structured, and based on the patient's individual agenda as well as reviewing and reinforcing basic self-management messages. Patients will be provided with an individualised self-management plan and symptom diary cards to use as a monitoring aid. Patients will be trained to identify and treat exacerbations associated with purulent sputum with antibiotic and those associated with increased breathlessness, mucoid sputum and/or upper airway symptoms with Prednisolone.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD
  • recent hospital admission with exacerbation
  • normal cognitive function (MMSE of 9 or 10)

Exclusion Criteria:

  • asthma
  • LVF
  • malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706303

Contacts
Contact: Christine E Bucknall, MD 44-141-201-3717 christine.bucknall@ggc.scot.nhs.uk
Contact: Brian Rae 44-141 brian.rae@ggc.scot.nhs.uk

Locations
United Kingdom
Greater Glasgow & Clyde NHS Board Recruiting
Glasgow, United Kingdom
Principal Investigator: Christine E Bucknall, MD         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Christine E Bucknall, MD GG&C NHS Board
  More Information

No publications provided by NHS Greater Glasgow and Clyde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GG&C Primary Care Division, Greater Glasgow & Clyde NHS Board
ClinicalTrials.gov Identifier: NCT00706303     History of Changes
Other Study ID Numbers: CZH/4/246
Study First Received: June 25, 2008
Last Updated: June 26, 2008
Health Authority: Scotland: Scottish Executive Health Department

Keywords provided by NHS Greater Glasgow and Clyde:
COPD
self management

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014