Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-04-01
2031-09-01
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Focus group cohort
Patients aged 18-100 with chronic cough including refractory chronic cough and unexplained chronic cough. Exclusions include: current smokers, ACE inhibitor use. Patients will be recruited to form focus groups to inform the creation of a cough control questionnaire. This will take the form of semi-structured interviews with open to closed questions. This same cohort will also engage in cognitive interviews after the preliminary cough control questionnaire has been made, to ensure that the language and wording is clear and appropriate. Recruitment will continue until thematic saturation is achieved.
Focus group interviews
Semi-structured focus group interviews for patients with refractory chronic cough
Validation study cohort
Patients aged 18-100 with chronic cough will be recruited. Exclusion criteria include: current smokers, smoking within the last 12 months, use of angiotensin converting enzyme inhibitor (ACEi), respiratory tract infection within the last 4 weeks and limited English.
Prospective consecutive patients with chronic cough will complete Cough Control Questionnaire, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
No interventions assigned to this group
Interventions
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Questionnaires
Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.
Focus group interviews
Semi-structured focus group interviews for patients with refractory chronic cough
Objective cough measures
Cough monitoring and cough sensitivity testing.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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King's College Hospital
London, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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KCH24-072
Identifier Type: -
Identifier Source: org_study_id
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