Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000109505
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
6/02/2015
Date last updated
6/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Regular Peak Flow Meter Utilisation on Asthma Self-Management
Scientific title
A crossover before-and-after randomised controlled-intervention pilot study, instigated by pharmacists, investigating whether regular peak flow meter utilisation with appropriate education can improve asthma control and engagement in asthma self-management in a Darwin population with previously diagnosed Asthma.
Secondary ID [1] 285958 0
None
Universal Trial Number (UTN)
U1111-1165-9890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 293888 0
Condition category
Condition code
Respiratory 294191 294191 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to explore the prospect of a pharmacist-instigated asthma self-management intervention; whether the introduction of a Peak Flow Meter with appropriate education can improve asthma control and engagement in asthma self-management.
The study was designed as a parallel before-and-after randomised controlled-intervention pilot study, conducted in four separate steps.
Step 1: The first meeting involved a guided survey (part 1: to gather the subjects’ baseline information) as well as two validated questionnaires (part 2: to assess the subject’s asthma knowledge and asthma control, and all participants were provided with asthma education.
Step 2: The second meeting involved the completion of the second survey by all participants (only part 2).
Participants allocated into the interventional group were provided with a peak flow meter, a diary to record their measurements, and education on how to use the device. The participants were encouraged to measure their peak expiratory flow every morning and whenever they feel that they may be experience airflow limitation. The participants allocated into the control group were not given any information about the PFM, however both groups’ asthma management was reviewed.
Step 3: At the third meeting all participants were asked to complete a third survey (only part 2). Participants in the control group were now provided with a PFM, a diary to record PEF measurements, and education on how to use the device (as per intervention group in Step 2).
In a follow-up, all participants were asked to complete a fourth survey (only part 2).
The meetings took place at a time and location convenient to the participant and researcher at 4-week intervals (+/-1 week), which took approximately 30 minutes per meeting.
Asthma education provided in the first meeting acted as a longitudinal control in order to exclude any improvement of asthma self-management due to asthma education during the introduction of the peak flow meter. Information about asthma and peak flow meter use was obtained through standardised material provided by the Asthma Foundation, the Pharmaceutical Society of Australia, evidence based researched information (e.g. journal articles, Asthma Management Handbook), and education delivered during the university course Bachelor of Pharmacy at Charles Darwin University.
Information provided included an explanation of asthma symptoms, aetiology and pathophysiology, relevant information about medications (e.g. relievers, preventers and symptom controllers) and asthma devices (including information about inhaler techniques and maintenance, benefits of certain devices, etc.). Further information was given about the perception of asthma symptoms, triggers, instructions on how to manage an asthma attack, and when to consult a doctor. Asthma management information comprised the treatment goals and self-management information on medication storage, breathing exercises, regular doctor reviews, AAP use, lifestyle modifications, exercise as well as diet and other medication that may influence asthma control. Further information was provided if requested such as on exercise-induced asthma, asthma-related diet and other considerations. The information was provided in accordance to individual’s treatment and needs. In addition, the subject inhaler technique was assessed, any questions were answered and written educational information was offered.
Intervention code [1] 290931 0
Treatment: Devices
Intervention code [2] 291016 0
Treatment: Other
Comparator / control treatment
The study was designed as a parallel before-and-after randomised controlled-intervention pilot study. The control group was not given the treatment device and their asthma management was compared to the intervention group that was given the treatment device. Four weeks after the intervention (carried out in the intervention group), the control group initiated the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293978 0
Assessment of effects of regular peak flow meter utilisation on asthma self-management assessed by validated questionnaires and formative feedback. The previously published validated questionnaires were the Asthma Control Questionnaire by Wheatbelt GP Network (Part 1), an asthma knowledge test from NIH MedlinePlus and the Asthma Control Test from Asthma UK (Part 2).
Timepoint [1] 293978 0
At four weeks after intervention commencement
Secondary outcome [1] 312270 0
Review of peak expiratory flow records
Timepoint [1] 312270 0
At intervention (during the second meeting when the peak flow meter was first introduced), and at four and eight weeks after the intervention commencement
Secondary outcome [2] 312524 0
To assess influence of peak flow meter utilisation on asthma control by the Asthma Control Test from Asthma UK
Timepoint [2] 312524 0
Four weeks (both groups) and eight weeks (intervention group only) after intervention (initiation of peak flow meter utilisation)
Secondary outcome [3] 312525 0
To assess if peak flow meter utilisation aids in recognising breathing difficulties by formative feedback.
Timepoint [3] 312525 0
Four weeks (both groups) and eight weeks (intervention group only) after intervention (initiation of peak flow meter utilisation)

Eligibility
Key inclusion criteria
1. Subjects must be 18 years old or over.
2. Subjects must be previously diagnosed with asthma by a doctor.
3. Subjects must be able to provide written informed consent.
4. Subjects must be able to understand information given and able to complete the survey.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects using a peak flow meter for their asthma self-management prior to the intervention.
2. Subjects unable to understand and comprehend the information provided.
3. Subjects unable to comply with the meeting requirements of this study.
4. Subjects refusing to participate in the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2013
Actual
22/06/2013
Date of last participant enrolment
Anticipated
Actual
24/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 290547 0
University
Name [1] 290547 0
Charles Darwin University
Country [1] 290547 0
Australia
Primary sponsor type
University
Name
Charles Darwin University
Address
Ellengowan Dr
Casuarina NT 0810
Country
Australia
Secondary sponsor category [1] 289241 0
Individual
Name [1] 289241 0
Julia Knobloch
Address [1] 289241 0
PO Box 339
Pyrmont 2009 NSW

Work Organisation:
Charles Darwin University
Ellengowan Dr
Casuarina NT 0810
Country [1] 289241 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292194 0
Human Research Ethics Committee
Ethics committee address [1] 292194 0
Ethics committee country [1] 292194 0
Australia
Date submitted for ethics approval [1] 292194 0
23/04/2013
Approval date [1] 292194 0
20/06/2013
Ethics approval number [1] 292194 0
H13072

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53974 0
Ms Julia Knobloch
Address 53974 0
PO Box 339
Pyrmont 2009 NSW

Work Organisation:
Charles Darwin University
Ellengowan Dr
Casuarina NT 0810
Country 53974 0
Australia
Phone 53974 0
+61404282705
Fax 53974 0
Email 53974 0
[email protected]
Contact person for public queries
Name 53975 0
Julia Knobloch
Address 53975 0
PO Box 339
Pyrmont 2009 NSW

Work Organisation:
Charles Darwin University
Ellengowan Dr
Casuarina NT 0810
Country 53975 0
Australia
Phone 53975 0
+61404282705
Fax 53975 0
Email 53975 0
[email protected]
Contact person for scientific queries
Name 53976 0
Julia Knobloch
Address 53976 0
PO Box 339
Pyrmont 2009 NSW

Work Organisation:
Charles Darwin University
Ellengowan Dr
Casuarina NT 0810
Country 53976 0
Australia
Phone 53976 0
+61404282705
Fax 53976 0
Email 53976 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

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