Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.
We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period.
STUDY DESIGN This is a single centre observational study.There are two parts to the study. Part 1. Comprises a screening and if suitable the patient will complete the novel questionnaire on one visit.
Part 2. Subjects will be screened, if suitable, patients will be asked to complete the questionnaire and 2-4 weeks later they will be asked to complete the questionnaire once more.
Informed consent and the screening assessment may be conducted either in person at the study site or by telephone, as detailed below.
Informed Consent at Site Potential subjects will be provided with the patient information sheet (PIS) and informed consent form (ICF) at site. A member of the research team will discuss the study with them and take them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject wishes to participate, they will sign and date two copies of the ICF, keeping one copy for themselves.
Informed Consent By Telephone
Potential subjects will be sent the PIS and ICF by post or email. Once they have had time to receive and read them, a member of the research team will contact the subject by phone to discuss the study and talk them through the information contained within the PIS and ICF. The subject will be encouraged to ask questions to ensure full understanding. If having read and understood the PIS and ICF the subject gives verbal consent to participate, one of the two following processes will be followed:
During screening, eligibility is checked by reference to the selection criteria. If the subject is assessed as eligible for the study, they are assigned a 3-digit subject number. The 3 digit numbers for these patients taking part in part 1, will be prefixed with 1 and those for Part 2, prefixed with a 2.
COUGH PATTERN ASSESSMENTS Part 1. 30 Study participants will be asked to identify their pattern of cough from the patterns identified on the questionnaire, if the patient feels they are unable to identify their pattern then they will be asked to draw a diagram of the pattern and explain the pattern of their cough during the day. This group of patients will be asked to comment on the questionnaire to allow for any improvements. Based on this initial questionnaire completion by this cohort of patients the questionnaire may be updated, especially if new patterns of cough are identified.
Part 2. 30 study participants will be asked to complete the potentially updated questionnaire and then a further copy of the questionnaire will be posted out to these patients for completion 2 to 4 weeks following the first recording on the questionnaire.
Cough frequency/ intensity and disruption Numerical Rating Scale The Cough frequency/ intensity/ and disruption NRS is an 11-point rating scale that patients will be asked to complete.
Each scale is worded as per example below
Now we woud like you to rate how often (frequently) you are coughing , the strength (intensity ) of the cough and overall how disruptive you feel your cough is to your daily life
Please circle most relevant number on scale How often do you cough (Frequency) 0 1 2 3 4 5 6 7 8 9 10 0= no coughing
There are 11 numbered boxes and subjects should select the one that best matches their perception of cough frequency, intensity and disruption to life.
The scores reported on each scale will be summed up to give a total score for severity . This will range from 0-30.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients | describe % of various cough patterns recorded and gender differnces and any new patterns | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| measure of cough severity | To sum up the cough frequency, intensity and disruption to daily life VAS scores to give a measure of cough severity | 1 day |
| describe any correlation between severity of cough and cough pattern |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients will be identified from those attending the chronic cough clinic or patients that have a history of chronic cough who have previously shown an interest in research.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Wright, BSc | Contact | 01482624067 | c.wright@hull.ac.uk | |
| Rachel Thompson | Contact | 01482624009 | r.h.thompson@hull.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital | Recruiting | Cottingham | East Yorkshiure | HU16 5JQ | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
Not provided
Not provided
Not provided
Not provided
Not provided
To compare cough frequency, intensity and disruption to life with pattern of cough, to determine if any correlation.
| 1 day |
| reproducibility of questionnnare | determine if questionnaire reproducible from repoerting at screening to 4 weeks later | 4 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |