- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00706303
Glasgow Supported Self Management Trial (GSuST) (GSuST)
Glasgow Supported Self-Management Randomised Controlled Trial for Patients With Moderate/ Severe COPD - GSuST
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Christine E Bucknall, MD
- Номер телефона: 44-141-201-3717
- Электронная почта: christine.bucknall@ggc.scot.nhs.uk
Учебное резервное копирование контактов
- Имя: Brian Rae
- Номер телефона: 44-141
- Электронная почта: brian.rae@ggc.scot.nhs.uk
Места учебы
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Glasgow, Соединенное Королевство
- Рекрутинг
- Greater Glasgow & Clyde NHS Board
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Главный следователь:
- Christine E Bucknall, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- COPD
- recent hospital admission with exacerbation
- normal cognitive function (MMSE of 9 or 10)
Exclusion Criteria:
- asthma
- LVF
- malignancy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: 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.
|
Без вмешательства: 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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
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?
Временное ограничение: 1 year
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1 year
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
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?
Временное ограничение: 1 year
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1 year
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Difference in length of hospital stay (all causes and sub classified by principle diagnosis)
Временное ограничение: 1 year
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1 year
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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?
Временное ограничение: i year
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i year
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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?
Временное ограничение: 1year
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1year
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Difference in mean NHS costs, anxiety, depression and self-efficacy scores over 1 year between the intervention group and the control group.
Временное ограничение: 1 year
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1 year
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Christine E Bucknall, MD, GG&C NHS Board
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CZH/4/246
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