Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000634471
Ethics application status
Approved
Date submitted
5/09/2007
Date registered
12/12/2007
Date last updated
9/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the style and content of general practice consultations for people with asthma
Scientific title
Improving the style and content of general practice consultations for people with asthma: a cluster randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in older people 2334 0
Condition category
Condition code
Respiratory 2436 2436 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GPs receive further training regarding asthma consultations by participating in 3 hours of education (a 2 hour interactive educational session and a 1 hour academic detaling session at their practice location)
Intervention code [1] 2052 0
Behaviour
Comparator / control treatment
Control group GPs were waitlisted to receive the educational intervention after completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 3337 0
Improvement in GP knowledge/satisfaction with the educational program
Timepoint [1] 3337 0
Baseline and after completion of the program
Secondary outcome [1] 5551 0
Improvement in patient outcomes
Timepoint [1] 5551 0
Baseline and at least 4months later

Eligibility
Key inclusion criteria
Patients with asthma
Minimum: age for patients is 55 years
Maximum: age for patients - no limit
Minimum age
55 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not considered competent to give consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The aim of this research was to conduct a randomised placebo controlled trial of an asthma education intervention for GPs, addressing the needs of older people with asthma to improve outcomes in this group.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2592 0
Government body
Name [1] 2592 0
Commonwealth Dept Health and Ageing
Country [1] 2592 0
Australia
Primary sponsor type
Individual
Name
Ms Dianne Goeman
Address
The Alfred Hospital (AIRmed)
Commercial Rd, Melbourne
Country
Australia
Secondary sponsor category [1] 2345 0
Individual
Name [1] 2345 0
Prof Jo Douglass
Address [1] 2345 0
The Alfred Hospital (AIRmed)
Commercial Rd, Melbourne
Country [1] 2345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4513 0
Ethics committee address [1] 4513 0
Ethics committee country [1] 4513 0
Date submitted for ethics approval [1] 4513 0
Approval date [1] 4513 0
27/10/2003
Ethics approval number [1] 4513 0
156/03

Summary
Brief summary
The aim of this research was to conduct a randomised placebo controlled trial of an asthma education intervention for GPs, addressing the needs of older people with asthma, to improve the outcomes in this group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28031 0
Address 28031 0
Country 28031 0
Phone 28031 0
Fax 28031 0
Email 28031 0
Contact person for public queries
Name 11188 0
Ms Dianne Goeman
Address 11188 0
The Alfred Hospital (AIRmed)
Commercial Rd, Melbourne
Country 11188 0
Australia
Phone 11188 0
(03) 9076 3216
Fax 11188 0
Email 11188 0
[email protected]
Contact person for scientific queries
Name 2116 0
Ms Dianne Goeman
Address 2116 0
The Alfred Hospital (AIRmed)
Commercial Rd, Melbourne
Country 2116 0
Australia
Phone 2116 0
(03) 9076 3216
Fax 2116 0
Email 2116 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
No additional documents have been identified.