Development of a Cough Control Questionnaire (CCQ)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Questionnaires, Focus group interviews, Objective cough measures.
- Кому может быть актуально
- Состояния в реестре: Cough. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Development and Validation of a Cough Control Questionnaire
Обзор
Chronic cough (\>8 weeks in duration) affects 5-12% of the global population, and is associated with considerable health status impairment and comorbidities. Currently, there are validated severity and impact outcome measures whilst objective measures with cough frequency monitoring is not available in routine clinical practice. Unlike other chronic respiratory diseases, namely asthma, there are no validated dedicated tools to assess the control of cough as a disease. This study aims to develop a validated patient-focused tool to assess the control of cough, which may be useful to evaluate the benefit and value of treatments in both clinical and research settings.
Подробное описание
This study will involve 3 phases:
* Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases. * Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients. * Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
Вмешательства
- Другое Questionnaires
Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life. - Другое Focus group interviews
Semi-structured focus group interviews for patients with refractory chronic cough - Другое Objective cough measures
Cough monitoring and cough sensitivity testing.
Первичные конечные точки
- A questionnaire to assess cough control [Срок оценки: 2 weeks]
Вторичные конечные точки (4)
- Cough severity [Срок оценки: 2 weeks]
- Cough-related quality of life and health status [Срок оценки: 2 weeks]
- Cough frequency [Срок оценки: 2 weeks]
- Cough reflex testing [Срок оценки: 2 weeks]
Критерии участия
Критерии включения
- Adult patients aged 18 and over with acute and chronic cough (including refractory chronic cough and unexplained chronic cough) and able to read and write in English. A smaller number (n =20) of healthy volunteers will also be included with no evidence of significant respiratory disease.
Критерии исключения
- Current smokers (or smoking within the last 12 months), respiratory tract infection within the last 4 weeks, use of angiotensin converting enzyme inhibitors (ACEi), and pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 1 центр
- King's College Hospital — London
Идентификаторы
NCT: NCT06918756 · KCH24-072