Development of a Cough Control Questionnaire (CCQ)

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Cough

Treatments: Other: Questionnaires; Other: Focus group interviews; Other: Objective cough measures

Study type: Observational

Funder types: Other

Identifiers

NCT06918756

KCH24-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Focus group cohort

Description:

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.

Treatment:

Other: Focus group interviews

Validation study cohort

Description:

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.