Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000639224
Ethics application status
Approved
Date submitted
24/06/2009
Date registered
30/07/2009
Date last updated
9/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Educational Intervention for Older People with Asthma
Scientific title
Educational program for older people with asthma to improve asthma control
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 237081 0
Condition category
Condition code
Respiratory 237402 237402 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational intervention to address the concerns of older people with asthma. One hour educational session after baseline measurement. 3 month and 12 month follow up adn outcome measurement
Intervention code [1] 236800 0
Behaviour
Comparator / control treatment
Brochure only education compared with comprehensive hands on educational program addressing specific concerns and device technique
Control group
Active

Outcomes
Primary outcome [1] 238205 0
Improvement in Asthma Control: Measured by Asthma Control Questionnaire, reduced number of asthma exacerbations, improvement in breathing by reduction in B2 agonist use and improved Lung function
Timepoint [1] 238205 0
at 3 and 12 months from baseline
Primary outcome [2] 238206 0
Improved Medication adherence: Measured by Adherence Questionnaire and tracking device monitoring of preventer
Timepoint [2] 238206 0
at 3 and 12 months from baseline
Secondary outcome [1] 244519 0
Improvement in Quality of life: Measured by Asthma Related Quality of Life Questionnaire
Timepoint [1] 244519 0
at 3 and 12 months from baseline

Eligibility
Key inclusion criteria
Age >55 years with doctor diagnosed asthma and currently using preventer therapy
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Fixed airflow obstruction post bronchodilator
Fev1/FVC <70% predicted
Smoking history plus 10 pack years

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 randomization table created by a computer software
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
Recruiting
Date of first participant enrolment
Anticipated
22/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1814 0
2000
Recruitment postcode(s) [2] 1812 0
3000

Funding & Sponsors
Funding source category [1] 237194 0
Other Collaborative groups
Name [1] 237194 0
Co-operative Research Centre for Asthma & Airways
Country [1] 237194 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Jo Douglass
Address
AIRMed
The Alfred Hospital
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 4689 0
Individual
Name [1] 4689 0
Prof Christine Jenkins
Address [1] 4689 0
Woolcock Institute
431 Glebe Rd, Glebe, NSW 2037
Country [1] 4689 0
Australia
Other collaborator category [1] 714 0
Individual
Name [1] 714 0
Ms Dianne Goeman
Address [1] 714 0
AIRMed
The Alfred Hospital
Melbourne Vic 3004
Country [1] 714 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239288 0
The Alfred Hospital
Ethics committee address [1] 239288 0
Commercial Rd
Melbourne Vic 3004
Ethics committee country [1] 239288 0
Australia
Date submitted for ethics approval [1] 239288 0
Approval date [1] 239288 0
15/12/2008
Ethics approval number [1] 239288 0
Project no 317/08

Summary
Brief summary
Asthma control of older people can be positively influenced by education addressing the major issues of: asthma beliefs at onset, treatment side effects, explanation of asthma diagnosis and device use education.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29787 0
Address 29787 0
Country 29787 0
Phone 29787 0
Fax 29787 0
Email 29787 0
Contact person for public queries
Name 13034 0
Assoc Prof Jo Douglass
Address 13034 0
AIRMed
The Alfred Hospital
Commercial Rd
Melbourne Vic 3004
Country 13034 0
Australia
Phone 13034 0
+61 3 9076 2934
Fax 13034 0
+61 3 9076 2245
Email 13034 0
j.douglass@alfred.org.au
Contact person for scientific queries
Name 3962 0
Assoc Prof Jo Douglass
Address 3962 0
AIRMed
The Alfred Hospital
Commercial Rd
Melbourne Vic 3004
Country 3962 0
Australia
Phone 3962 0
+61 3 9076 2934
Fax 3962 0
+61 3 9076 2245
Email 3962 0
j.douglass@alfred.org.au

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.