Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000526471
Ethics application status
Approved
Date submitted
8/10/2007
Date registered
11/10/2007
Date last updated
21/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicentre Evaluation of Management Protocol for Chronic Cough in Children
Scientific title
Does the use of a standardised protocol for the treatment of chronic cough in children improve clinical outcomes by the 6 week timepoint?
Secondary ID [1] 279989 0
No seconday ID
Universal Trial Number (UTN)
Trial acronym
MSCAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Cough in Children 2415 0
Condition category
Condition code
Respiratory 2522 2522 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the project will be treated in accordance with a standardised protocol (flowchart). Participants will be asked to complete validated quality of life questionnaires at point of referral, 6 weeks, 10 weeks, 14 weeks, 26 weeks and 52 weeks, or until such point as the cough has ceased. Participants will be randomised to active arm (consultation and treatment according to flowchart within 2 weeks of referral) or control arm (consultation and treatment according to flowchart according to usual waiting time of instituition/practitioner, usually 6 weeks).
Intervention code [1] 2139 0
Other interventions
Comparator / control treatment
Comparator is use of standardised protocol within a timeframe.
Control group
Active

Outcomes
Primary outcome [1] 3419 0
% of participants who are cough free (as scored by parents on daily cough diaries)
Timepoint [1] 3419 0
measured at 6 weeks from point of each participants referral to participating investigator (practitioner)
Primary outcome [2] 3420 0
Difference in Quality of Life score (as recorded on validated Parent-proxy cough specific quliaty of life tool (PC-QOL), and commercially available age specific PedsQL tool)
Timepoint [2] 3420 0
Quality of life (PC-QOL and PedsQL) collected from participants at referral, week 6, week 10, week 14, week 26 and week 52, or until the cough has ceased (score of 0 for 3-5 consecutive days on parent completed cough diary). QOL collected at time of cough ceasing if this is in between set time points.
Secondary outcome [1] 5680 0
% of children where a primary diagnosis is achieved
Timepoint [1] 5680 0
% of children where primary diagnosis is achieved will be measured at completion of study period. Endpoint of study involvement for each participant is when child ceases coughing OR at 12 months from recruitment into study.

Eligibility
Key inclusion criteria
Child (aged 0-18 years) newly referred to participating study physician for investigation/treatment of cough that has persisted for greater than 4 weeks.
Minimum age
N/A
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are screened upon referral to the respiratory physician and invited to participate. They are randomly allocated to intervention or control group. Allocation is by computed generated permutated block design and is concealed on allocation sheet by covered labels until after randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is by permutated block design by computer generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2672 0
Government body
Name [1] 2672 0
NHMRC
Country [1] 2672 0
Australia
Primary sponsor type
Individual
Name
Prof Anne Chang
Address
Dept Respiratory Medicine
Royal Children's Hospital
Herston Rd, Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 2414 0
None
Name [1] 2414 0
Address [1] 2414 0
Country [1] 2414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4590 0
Royal Children's Hospital and Health Service District Ethics Committee
Ethics committee address [1] 4590 0
Royal Children's Hospital
Herston Rd, Herston
QLD 4029
Ethics committee country [1] 4590 0
Australia
Date submitted for ethics approval [1] 4590 0
Approval date [1] 4590 0
19/03/2007
Ethics approval number [1] 4590 0
2006/063
Ethics committee name [2] 4591 0
ACT Health Human Research Ethics Committee
Ethics committee address [2] 4591 0
Level 3,
11 Moore Street
Canberra City
ACT 2601
Ethics committee country [2] 4591 0
Australia
Date submitted for ethics approval [2] 4591 0
Approval date [2] 4591 0
19/09/2007
Ethics approval number [2] 4591 0
ETH.1/07.111

Summary
Brief summary
The primary purpose of this study is to evaluate the use of a management protocol designed to improve the management of children with chronic cough. Cough that lasts greater than 4 weeks in children has been shown to cause considerable anxiety to parents and presents a major management problem to the treating doctor. This study aims to prove the hypothesis that the management of chronic cough in children in accordance with a management protocol is feasible and efficient, and improves clinical outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28083 0
Address 28083 0
Country 28083 0
Phone 28083 0
Fax 28083 0
Email 28083 0
Contact person for public queries
Name 11240 0
Emily Bailey
Address 11240 0
Dept of Respiratory Medicine
Royal Children's Hospital
Herston Rd, Herston
QLD 4029
Country 11240 0
Australia
Phone 11240 0
+617 3636 9253
Fax 11240 0
+61736369158
Email 11240 0
[email protected]
Contact person for scientific queries
Name 2168 0
A/Prof Anne Chang
Address 2168 0
Dept of Respiratory Medicine
Royal Children's Hospital
Herston Rd, Herston
QLD 4029
Country 2168 0
Australia
Phone 2168 0
+617 36368111
Fax 2168 0
Email 2168 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4221Study results articleYes A. B. Chang, C. F. Robertson, P. P. van Asperen, N... [More Details]

Documents added automatically
No additional documents have been identified.