Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376448
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
Official Title:
An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 itsintensity 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
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
Detailed Description:
STUDY DESIGN This is a single centre observational studyThere 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
If the full consent discussion has been witnessed at the site the witness will sign the ICF to confirm that all aspects of the study have been discussed and the subject has freely given verbal informed consent A copy of the signed ICF will then be sent to the subject
If the consent discussion has not been witnessed at the site the subject will sign and date two copies of the ICF return one copy to the research team and keep the other copy for themselves
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
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
If the full consent discussion has been witnessed at the site the witness will sign the ICF to confirm that all aspects of the study have been discussed and the subject has freely given verbal informed consent A copy of the signed ICF will then be sent to the subject
If the consent discussion has not been witnessed at the site the subject will sign and date two copies of the ICF return one copy to the research team and keep the other copy for themselves
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None