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Glasgow Supported Self Management Trial (GSuST) (GSuST)

26. Juni 2008 aktualisiert von: 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

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

500

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Glasgow, Vereinigtes Königreich
        • Rekrutierung
        • Greater Glasgow & Clyde NHS Board
        • Hauptermittler:
          • Christine E Bucknall, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

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

Exclusion Criteria:

  • asthma
  • LVF
  • malignancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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?
Zeitfenster: 1 year
1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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?
Zeitfenster: 1 year
1 year
Difference in length of hospital stay (all causes and sub classified by principle diagnosis)
Zeitfenster: 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?
Zeitfenster: 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?
Zeitfenster: 1year
1year
Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group.
Zeitfenster: 1 year
1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Christine E Bucknall, MD, GG&C NHS Board

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2007

Primärer Abschluss (Voraussichtlich)

1. Dezember 2008

Studienabschluss (Voraussichtlich)

1. Dezember 2009

Studienanmeldedaten

Zuerst eingereicht

25. Juni 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2008

Zuerst gepostet (Schätzen)

27. Juni 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Juni 2008

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2008

Zuletzt verifiziert

1. Juni 2008

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CZH/4/246

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