Glasgow Supported Self Management Trial (GSuST)

NCT00706303 | Unknown

• 1 other identifier: CZH/4/246
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; self management

Outcome Measures

Primary Outcomes (1)

• 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?

  1 year

Secondary Outcomes (5)

• 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

Study Arms (2)

1 Intervention group

ACTIVE COMPARATOR

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

2

NO INTERVENTION

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

Interventions

Supported self management training and support BEHAVIORAL

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.

1 Intervention group; 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• asthma
• LVF
• malignancy

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (1)

Greater Glasgow & Clyde NHS Board

Glasgow, United Kingdom

RECRUITING

Related Publications (1)

• Bucknall CE, Miller G, Lloyd SM, Cleland J, McCluskey S, Cotton M, Stevenson RD, Cotton P, McConnachie A. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial. BMJ. 2012 Mar 6;344:e1060. doi: 10.1136/bmj.e1060.

  PMID: 22395923 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christine E Bucknall, MD

  GG&C NHS Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine E Bucknall, MD

CONTACT

44-141-201-3717; christine.bucknall@ggc.scot.nhs.uk

Brian Rae

CONTACT

44-141; brian.rae@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

GB (1)