Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000262505
Ethics application status
Approved
Date submitted
9/03/2015
Date registered
19/03/2015
Date last updated
1/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of respiratory symptoms in cystic fibrosis
Scientific title
The psychometric properties of the Leicester Cough Questionnaire in adults with cystic fibrosis.
Secondary ID [1] 285955 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 293882 0
Condition category
Condition code
Respiratory 294185 294185 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 294796 294796 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A prospective observational study investigating the psychometric properties of the Leicester Cough Questionnaire and a short symptom screening tool (Respiratory Symptoms in CF - ReS-CF) for use in people with cystic fibrosis. The questionnaires will be completed during a period of stability and also pre/post treatment for a respiratory exacerbation.
Intervention code [1] 290925 0
Not applicable
Comparator / control treatment
The Leicester Cough Questionnaire will be compared to the Cystic Fibrosis Questionnaire (Revised) (current gold standard) and the Respiratory Symptoms in cystic fibrosis tool.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293973 0
Determination of the psychometric properties of the Leicester Cough Questionnaire in cystic fibrosis. Concurrent validity will be determined by calculating correlation coefficients using either the Pearson correlation coefficient or Spearman’s rank correlation coefficient depending on the distribution of the data (determined by visual inspection and skewness and kurtosis statistics). Internal consistency of the Leicester Cough Questionnaire (total and 3 domains) will be determined using Cronbach’s alpha coefficient. Cronbach’s alpha scores of 0.7-0.9 will be selected to represent appropriate internal consistency. Content validity will be determined by analysing for floor and ceiling effects, with less than 15% of subjects achieving either the minimum or maximum scores considered acceptable. Reliability of the Leicester Cough Questionnaire and Respiratory Symptoms in cystic fibrosis (domain and total scores) will be analysed using Intraclass Correlation Coefficients (ICC). Correlation coefficients greater than 0.8 will be considered to represent strong correlation, 0.6-0.79 to represent moderate correlation, 0.4-0.59 to reflect fair correlation and less than 0.4 to represent poor or no correlation. Repeatability will be determined using Bland-Altman plots. Responsiveness will be analysed by calculating the effect size.
Timepoint [1] 293973 0
Patients with stable respiratory disease will be assessed twice, separated by one week. Patients who have a respiratory exacerbation will be assessed at commencement of treatment of the exacerbation and 4 weeks later.
Secondary outcome [1] 313599 0
Nil.
Timepoint [1] 313599 0
Nil.

Eligibility
Key inclusion criteria
Diagnosis of cystic fibrosis, attending the Royal Adelaide Hospital Adult Cystic Fibrosis Service
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand written English, development of critical illness/implementation of end of life care/surgical intervention during study period

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Concurrent validity will be determined by calculating correlation coefficients using either the Pearson correlation coefficient or Spearman’s rank correlation coefficient depending on the distribution of the data (determined by visual inspection and skewness and kurtosis statistics). Internal consistency of the Leicester Cough Questionnaire (total and 3 domains) will be determined using Cronbach’s alpha coefficient. Cronbach’s alpha scores of 0.7-0.9 will be selected to represent appropriate internal consistency. Content validity will be determined by analysing for floor and ceiling effects, with less than 15% of subjects achieving either the minimum or maximum scores considered acceptable. Reliability of the Leicester Cough Questionnaire and Respiratory Symptoms in cystic fibrosis (domain and total scores) will be analysed using Intraclass Correlation Coefficients (ICC). Correlation coefficients greater than 0.8 will be considered to represent strong correlation, 0.6-0.79 to represent moderate correlation, 0.4-0.59 to reflect fair correlation and less than 0.4 to represent poor or no correlation. Repeatability will be determined using Bland-Altman plots. Responsiveness will be analysed by calculating the effect size.
Because there are no data in cystic fibrosis on which to base sample size calculations, both phases of the study will use a sample of convenience, namely patients attending the Royal Adelaide Hospital Cystic Fibrosis Service. Currently, there are approximately 120 patients attending this service and it is hoped that a sample of 100 participants will participate in the reliability and validity phase of the study. This will provide sufficient data to evaluate the measurement properties of the questionnaires in those with mild, moderate and severe cystic fibrosis lung disease. The responsiveness phase will aim to recruit all patients who meet the eligibility criteria between January and June 2015. Whilst there are no current data available to indicate how many patients received new oral, inhaled or intravenous antibiotics within our service over a similar time period, we believe that it should be possible to recruit at least 20 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/03/2015
Actual
27/03/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
28/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3316 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 9099 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290535 0
Self funded/Unfunded
Name [1] 290535 0
Country [1] 290535 0
Primary sponsor type
Individual
Name
Nathan Ward
Address
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 289228 0
Individual
Name [1] 289228 0
Anne Holland
Address [1] 289228 0
c/o La Trobe University Clinical School
Alfred Health
Level 4, The Alfred Centre
99 Commerical Rd
Melbourne
Vic 3004
Country [1] 289228 0
Australia
Secondary sponsor category [2] 289309 0
Individual
Name [2] 289309 0
Kathy Stiller
Address [2] 289309 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [2] 289309 0
Australia
Secondary sponsor category [3] 289310 0
Individual
Name [3] 289310 0
Hilary Rowe
Address [3] 289310 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [3] 289310 0
Australia
Secondary sponsor category [4] 289311 0
Individual
Name [4] 289311 0
Wee-Ren Kong
Address [4] 289311 0
c/o Physiotherapy
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [4] 289311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292187 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 292187 0
Level 3, Hanson Institute, IMVS Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 292187 0
Australia
Date submitted for ethics approval [1] 292187 0
30/12/2014
Approval date [1] 292187 0
02/01/2015
Ethics approval number [1] 292187 0
150101
Ethics committee name [2] 292188 0
La Trobe University College Human Research Ethics Committee
Ethics committee address [2] 292188 0
c/o Secretary, University Human Ethics Committee
La Trobe University
Bundoora
Vic 3086
Ethics committee country [2] 292188 0
Australia
Date submitted for ethics approval [2] 292188 0
09/01/2015
Approval date [2] 292188 0
05/03/2015
Ethics approval number [2] 292188 0

Summary
Brief summary
An observational trial to determine the usefulness of the Leicester Cough Questionnaire and a short symptoms assessment tool (Respiratory Symptoms in Cystic Fibrosis) in people with cystic fibrosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53962 0
Mr Nathan Ward
Address 53962 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53962 0
Australia
Phone 53962 0
+61882225574
Fax 53962 0
Email 53962 0
[email protected]
Contact person for public queries
Name 53963 0
Mr Nathan Ward
Address 53963 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53963 0
Australia
Phone 53963 0
+61882225574
Fax 53963 0
Email 53963 0
[email protected]
Contact person for scientific queries
Name 53964 0
Mr Nathan Ward
Address 53964 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 53964 0
Australia
Phone 53964 0
+61882225574
Fax 53964 0
Email 53964 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe psychometric properties of the Leicester Cough Questionnaire and Respiratory Symptoms in CF tool in cystic fibrosis: A preliminary study.2017https://dx.doi.org/10.1016/j.jcf.2016.11.011
N.B. These documents automatically identified may not have been verified by the study sponsor.