Chronic Obstructive Pulmonary DiseaseGSuSTNCT00706303
Glasgow Supported Self Management Trial (GSuST)
A study testing Supported self management training and support in people with Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Supported self management training and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD
- recent hospital admission with exacerbation
- normal cognitive function (MMSE of 9 or 10)
Who cannot join
- asthma
- LVF
- malignancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Greater Glasgow & Clyde NHS Board
Glasgow
Christine E Bucknall, MD
About this study
Official title: Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST
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
Read the 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:
- 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Supported self management training and support
- Keywords
- COPD, self management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported self management training and supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supported self management training and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: 1 year
Difference in length of hospital stay (all causes and sub classified by principle diagnosis)
Measured: 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?
Measured: 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?
Measured: 1year
Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Investigators
- Christine E Bucknall, MD, Principal investigator, GG&C NHS Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706303
- Sponsor's protocol ID
- CZH/4/246
- Acronym
- GSuST
- Status last verified
- Jun 2008
- First submitted
- 25 Jun 2008
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22395923
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST
- ClinicalTrials.gov ID
- NCT00706303
- Acronym / sponsor ID
- GSuST / CZH/4/246
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, self management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Intervention group | Active comparator | Behavioral: Supported self management training and supportSupported 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. |
| 2 | No intervention | Behavioral: Supported self management training and supportUsual 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- COPD
- recent hospital admission with exacerbation
- normal cognitive function (MMSE of 9 or 10)
Key exclusion criteria (3 listed)
- asthma
- LVF
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supported self management training and supportSupported 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. | Behavioural | 1 Intervention group, 2 |
Primary outcome
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
5 secondary outcomes
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
Difference in length of hospital stay (all causes and sub classified by principle diagnosis)
Time frame: 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?
Time frame: 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?
Time frame: 1year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
- Derived from this study: PubMed 22395923Bucknall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E Bucknall, MD principal investigator
GG&C NHS Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported self management training and support in people with Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine E Bucknall, MD (44-141-201-3717, christine.bucknall@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2008.