Development of a Cough Control Questionnaire (CCQ)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires, Focus group interviews, Objective cough measures.
- Who it may be relevant to
- Registry conditions: Cough. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Development and Validation of a Cough Control Questionnaire
Overview
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.
Detailed description
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.
Interventions
- Other Questionnaires
Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life. - Other Focus group interviews
Semi-structured focus group interviews for patients with refractory chronic cough - Other Objective cough measures
Cough monitoring and cough sensitivity testing.
Primary outcome measures
- A questionnaire to assess cough control [Time frame: 2 weeks]
Secondary outcome measures (4)
- Cough severity [Time frame: 2 weeks]
- Cough-related quality of life and health status [Time frame: 2 weeks]
- Cough frequency [Time frame: 2 weeks]
- Cough reflex testing [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- King's College Hospital — London
Identifiers
NCT: NCT06918756 · KCH24-072