Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000854033
Ethics application status
Approved
Date submitted
8/10/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management to Improve Control of Asthma study
Scientific title
A cluster randomised trial with a factorial design to test the effectiveness of two brief asthma management interventions for improving asthma control and reducing morbidity in primary care, compared with usual care alone
Secondary ID [1] 252843 0
none
Universal Trial Number (UTN)
Trial acronym
MICA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 258357 0
Condition category
Condition code
Respiratory 258538 258538 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inhaled Salmeterol/fluticasone (all groups);
This study will compare four brief asthma management strategies for delivery by general practitioners (GPs) during normal consultations.
Intervention code [1] 257362 0
Behaviour
Comparator / control treatment
The active control group GPs will deliver usual care. The GPs will provide a written asthma action plan for each patient at baseline and review the patient's level of asthma control and the written asthma action plan with the patient at week 4.
Control group
Active

Outcomes
Primary outcome [1] 259375 0
Level of asthma control, assessed by the validated Asthma Score questionnaire (also called the Asthma Control Test).
Timepoint [1] 259375 0
Baseline and 1-2, 8, 16, 24 weeks after intervention commencement
Secondary outcome [1] 265893 0
Asthma-related quality of life, assessed by the Mini Asthma Quality of Life Questionnaire (Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J 1999;14:32-38.)
Timepoint [1] 265893 0
1-2, 8, 16 and 24 weeks after intervention commencement
Secondary outcome [2] 265894 0
Forced expiratory volume in one second (FEV1), assessed by portable spirometer.
Timepoint [2] 265894 0
1-2, 8, 16 and 24 weeks after intervention commencement
Secondary outcome [3] 265895 0
Episodes of urgent health care utilisation and scheduled doctor visits, assessed by GP-completed questionnaire using data from the patients medical records.
Timepoint [3] 265895 0
24 weeks after intervention commencement

Eligibility
Key inclusion criteria
GPs
(a) Access to a computer and email during consultations

Patients
(a) Age 14-65 yrs
(b) Current prescription for inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) (the most common preventer treatment in Australia)
(c) Asthma not well-controlled (Asthma Score <=19)
Minimum age
14 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
GPs:
Access to a computer and email in the practice.
Patients:
Exclusion criteria:
(a) asthma exacerbation (oral corticosteroids (OCS), emergency department (ED) visit or hospitalisation) in the last month
(b) other major respiratory disease e.g. Chronic Obstructive Pulmonary Disease (COPD), or serious uncontrolled medical condition
(c) Symbicort Single inhaler Maintenance And Reliever Therapy (SMART) therapy
(d) shift work with a variable roster
(e) pregnancy* or lactation
(f) clinically-important visual or auditory impairment
*The management of females who become pregnant during the study should be according to clinical need. Due to the possibility that treatment may need to be changed, patients becoming pregnant during the study will be withdrawn. However, since all participants will already be using ICS/LABA, no pregnancy test is required at study start.

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)
This is a 6-month cluster randomized controlled trial. GPs will be individually randomised, with each GP's patients representing one cluster.
GPs:
GPs will be recruited by letter of invitation from their Division of General Practice. Treatment allocation will be by a computer-generated random code. GPs will be advised that the study is comparing four different management strategies, but to avoid unblinding, they will only be given information about the strategies for their own randomisation group.
Patients:
Patients will be recruited by reception staff of participating GPs in order to minimise bias. The GP will check patients’ eligibility criteria and obtain written informed consent. Patients will be allocated their treatment on the basis of their GP’s randomisation. The GP will provide the patient with the Participant Information Statement, which to avoid unblinding will only contain information relevant to their own randomisation group.

The person who will determine if a GP is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the GP will be allocated.

Allocation of GPs will be by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
GPs will be individually randomised, with each GP's patients representing one cluster. Randomisation of GPs will be by a computer-generated random code, with a minimisation algorithm to ensure (1) a balance of GP locations by socio-economic area and (2) a balance of previous asthma/COPD management training in the past 12 months (3) a balance of second language spoken (English or other). GPs will be randomised separately to active and control groups for the two interventions, using a 2x2 factorial design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Cluster study, with each GP’s patients the unit of cluster.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257811 0
Government body
Name [1] 257811 0
National Health and Medical Research Council
Country [1] 257811 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
PO Box M77, Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 257016 0
None
Name [1] 257016 0
Address [1] 257016 0
Country [1] 257016 0
Other collaborator category [1] 251546 0
Charities/Societies/Foundations
Name [1] 251546 0
Dr Juliet Foster
Address [1] 251546 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, Camperdown NSW 2050
Country [1] 251546 0
Australia
Other collaborator category [2] 251547 0
University
Name [2] 251547 0
Dr Lorraine Smith
Address [2] 251547 0
Pharmacy Building (A15), University of Sydney, Sydney, NSW, 2006
Country [2] 251547 0
Australia
Other collaborator category [3] 251548 0
Hospital
Name [3] 251548 0
Professor Susan Sawyer
Address [3] 251548 0
Centre for Adolescent Health, William Buckland House, 2 Gatehouse St, Parkville Vic 3052
Country [3] 251548 0
Australia
Other collaborator category [4] 251549 0
Hospital
Name [4] 251549 0
Professor Timothy Usherwood
Address [4] 251549 0
Western Clinical School C24 - Westmead Hospital The University of Sydney NSW 2006 Australia
Country [4] 251549 0
Australia
Other collaborator category [5] 251550 0
University
Name [5] 251550 0
Professor Cynthia Rand
Address [5] 251550 0
Johns Hopkins Center for Mind-Body Research, Asthma Center 4B-72, 4940 Eastern Avenue, Baltimore, Maryland 21224
Country [5] 251550 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259834 0
Human Research Ethics Committee
Ethics committee address [1] 259834 0
THE UNIVERSITY OF SYDNEY, Level 6, Jane Foss Russell Building - G02, The University of Sydney, NSW 2006
Ethics committee country [1] 259834 0
Australia
Date submitted for ethics approval [1] 259834 0
Approval date [1] 259834 0
27/05/2009
Ethics approval number [1] 259834 0

Summary
Brief summary
The main goal of asthma treatment is to achieve good asthma control. This cluster randomised trial will test the effectiveness of two brief asthma management interventions, delivered by GPs, for improving asthma control in primary care. The effect of both interventions separately and their interaction will be tested by multiple linear regression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31751 0
Address 31751 0
Country 31751 0
Phone 31751 0
Fax 31751 0
Email 31751 0
Contact person for public queries
Name 14998 0
Associate Professor Helen Reddel
Address 14998 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, Camperdown NSW 2050
Country 14998 0
Australia
Phone 14998 0
+61 2 9114 0437
Fax 14998 0
+61 2 9114 0014
Email 14998 0
[email protected]
Contact person for scientific queries
Name 5926 0
Associate Professor Helen Reddel
Address 5926 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road, Camperdown NSW 2050
Country 5926 0
Australia
Phone 5926 0
+61 2 9114 0437
Fax 5926 0
+61 2 9114 0014
Email 5926 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
EmbaseBarriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials.2015https://dx.doi.org/10.1186/s12874-015-0012-3
EmbaseGeneral practitioner-delivered adherence counseling in asthma: Feasibility and usefulness of skills, training and support tools.2016https://dx.doi.org/10.3109/02770903.2015.1091473
N.B. These documents automatically identified may not have been verified by the study sponsor.