Glasgow Supported Self Management Trial (GSuST) (GSuST)
26 giugno 2008 aggiornato da: NHS Greater Glasgow and Clyde
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
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
500
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Glasgow, Regno Unito
- Reclutamento
- Greater Glasgow & Clyde NHS Board
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Investigatore principale:
- Christine E Bucknall, MD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- COPD
- recent hospital admission with exacerbation
- normal cognitive function (MMSE of 9 or 10)
Exclusion Criteria:
- asthma
- LVF
- malignancy
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
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.
|
|
Nessun intervento: 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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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?
Lasso di tempo: 1 year
|
1 year
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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?
Lasso di tempo: 1 year
|
1 year
|
|
Difference in length of hospital stay (all causes and sub classified by principle diagnosis)
Lasso di tempo: 1 year
|
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?
Lasso di tempo: i year
|
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?
Lasso di tempo: 1year
|
1year
|
|
Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group.
Lasso di tempo: 1 year
|
1 year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christine E Bucknall, MD, GG&C NHS Board
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2007
Completamento primario (Anticipato)
1 dicembre 2008
Completamento dello studio (Anticipato)
1 dicembre 2009
Date di iscrizione allo studio
Primo inviato
25 giugno 2008
Primo inviato che soddisfa i criteri di controllo qualità
26 giugno 2008
Primo Inserito (Stima)
27 giugno 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 giugno 2008
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 giugno 2008
Ultimo verificato
1 giugno 2008
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CZH/4/246
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