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Trial registered on ANZCTR


Registration number
ACTRN12610000159055
Ethics application status
Approved
Date submitted
14/02/2010
Date registered
18/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving health outcomes for Jordanian outpatients with asthma
Scientific title
Assessing the effectiveness of Inhaler Technique Labels on asthma patients' inhaler technique
Secondary ID [1] 1405 0
None
Universal Trial Number (UTN)
Trial acronym
Improving health outcomes for Jordanian outpatients with asthma
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 256815 0
Condition category
Condition code
Respiratory 256967 256967 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is conducted to assess the current asthma control, asthma knowledge, inhaler technique and the source and content of previous educational advice about inhaler use, Peak FLow Meter (PFM) use, use of asthma medications and other alternative treatments for outpatients in Amman, Jordan who are using asthma controller medications by Turbuhaler, Diskus or Metered Dose Inhaler (MDIs). This will be done by a 15 minute interview with the patients at baseline.
The second part of the trial will compare the effect on inhaler technique and asthma outcomes of inhaler technique labels, used as part of inhaler technique education (verbal plus physical demonstration), compared with inhaler technique education alone, in patients receiving asthma controller medications by Turbuhaler or Diskus. Patients will be randomised to receive one of the two educatrional methods at baseline. The educational session will take about 10 minutes. Patients will be met at their doctor's clinic by the researcher 3 months following baseline and will be assessed on their inhaler technique during a 10 minute session.
Intervention code [1] 256023 0
Treatment: Devices
Comparator / control treatment
Patients with asthma receiving inhaler technique education (verbal and physical demonstration) with no technique labels
Control group
Active

Outcomes
Primary outcome [1] 257851 0
The primary outcome measure is inhaler technique score (out of 9), assessed 3 months after the educational intervention (inhaler technique education).
Timepoint [1] 257851 0
This study is a 3 month single-blind randomised parallel group active-controlled study. Patients will be assessed at baseline and 3 months following baseline.
Secondary outcome [1] 263299 0
Improvements in Asthma Control for patients from baseline to 3 months following baseline. This will be done by verbally explaining to the patient the steps to follow in their inhaler use, physically showing them how to complete each step in the technique, then placing a label with the steps of the technique on their inhalers, highlighting their initiall mistakes.
Timepoint [1] 263299 0
Patients will be assessed at baseline and 3 months following baseline.
Secondary outcome [2] 263300 0
Current asthma control status (to be assessed using the validated Asthma Control Test questionnaire) for patients using Turbuhaler, Accuhaler and MDI preventer inhalers in correlation to their inhaler technique score out of nine (which will be assessed based on their inhaler technique demonstration skills, where one point will be awarded for each step (9 steps checklists) demonstrated correctly by the patient.
Timepoint [2] 263300 0
At baseline

Eligibility
Key inclusion criteria
Inclusion criteria will include patients >=14 years of age, have a doctor-diagnosis of asthma, currently using inhaled corticosteroids with or without long acting B2 agonists via Turbuhaler or Diskus, and have been on the same asthma medication and dose for a minimum of one month prior to study enrolment.
Minimum age
14 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they do not self-administer their medication, do not speak or understand Arabic, are not able to return for all visits, or are involved in another clinical 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)
During the study, patients with asthma who are visiting the respiratory clinics of the Jordanian University Hospital (A public hospital) and Al Eslami hospital (A private hospital) in Amman will be approached by the researcher for participation. Those who are eligible (using Metered dose inhalers, Turbuhalers or Diskus), agree to be involved in the study and provide written informed consent will be enrolled. Patients will be randomised to active and control using a computerized list (excel with numbers from 1 to 300), with stratification according to baseline level of asthma control (based on the Asthma Control Test questionnaire with a cut point of less than or equal to 19) and type of inhaler. Allocation to Control and Active groups was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients who are using one of the dry powder preventer inhalers (Turbuhaler and Diskus) will be randomised to one of two interventions using a computerized list, with stratification according to baseline level of asthma control as assessed by the Asthma Control Test (with a cut point of less than or equal to 19) and type of inhaler. Randomisation will be double-blind (Education of inhaler technique and followup assessment of technique will be delivered by different researchers. The second researcher will be blineded to the type of education delivered to the patients by the first researcher)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2496 0
Jordan
State/province [1] 2496 0
Amman

Funding & Sponsors
Funding source category [1] 256521 0
University
Name [1] 256521 0
Applied Science University
Address [1] 256521 0
Applied Science University Private
Shafa Badran
PO Box 111931
Amman
Jordan

(we do not include street names in the addresses in Jordan)
Country [1] 256521 0
Jordan
Primary sponsor type
University
Name
Applied Science University
Address
Applied Science University Private
Shafa Badran
PO Box 111931
Amman
Jordan

(we do not include street names in the addresses in Jordan)
Country
Jordan
Secondary sponsor category [1] 255832 0
None
Name [1] 255832 0
Address [1] 255832 0
Country [1] 255832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258569 0
Jordan Ministry of Health
Ethics committee address [1] 258569 0
P.O Box 86
Amman, 11118, Jordan
Ethics committee country [1] 258569 0
Jordan
Date submitted for ethics approval [1] 258569 0
16/04/2009
Approval date [1] 258569 0
11/05/2009
Ethics approval number [1] 258569 0
MB1/6525

Summary
Brief summary
This study is a 3 month single-blind randomised parallel group active-controlled study, examining the effectiveness of inhaler technique education plus inhaler technique labels, compared with inhaler technique education alone.
During the Outpatient study, patients with asthma who are visiting the respiratory clinics of the Jordanian University Hospital (A public hospital), Al Basheer hospital (public hospital) and Al Eslami hospital (A private hospital) in Amman will be approached by the researcher for participation. Those who are eligible, agree to be involved in the study and provide written informed consent. Data to be collected from the patients at this point will include their demographic data, asthma control test, name of asthma medications used, time of inhaler use, previous advice received on asthma inhaler use, use of other asthma treatments, asthma knowledge test, and Peak Flow Meter use. Patients will be assessed on therir inhaler technique (MDI, Turbuhaler and Diskus) by the researcher using validated inhaler technique checklists, with placebo inhalers provided by AstraZeneca (Amman, Jordan) and GSK (Amman, Jordan). The placebo inhaler used for each patient will be labeled with the patient’s ID number and initials, and stored in a plastic bag for use at subsequent visits.
Patients who are using one of the dry powder preventer inhalers (Turbuhaler and Diskus) will be randomised to one of two interventions using a computerized list, with stratification according to baseline level of asthma control as assessed by the Asthma Control Test (with a cut point of less than or equal to 19) and type of inhaler. Randomisation will be single-blind, and the focus on inhaler technique will be concealed from participants until after the baseline assessments have been completed. Following randomisation, each patient’s inhaler technique will be optimized following one of two counseling methods. For Group A (“Education + inhaler label”), counseling will be based on previous published research findings by the research group. The researcher will educate the patient using a specialized ‘‘Show and Tell’’ Inhaler Technique counseling service going through each step on the checklist (in Arabic) to describe and demonstrate correct use. This cycle of assessment and counseling will be repeated up to three times if necessary, until the patient demonstrates correct technique on all steps. At the completion of counseling, the researcher will use a highlighter pen to identify any incorrect steps from the patient’s initial assessment on an ‘‘Inhaler Technique Label’’ which is preprinted with the relevant checklist (in Arabic). The researcher will attach the highlighted label to the patient’s own controller medication inhaler (not the box), without covering any essential information. Patients in Group B (“Education alone”) will receive the same counseling as above but without the inhaler technique labels. All participants will be assessed on their inhaler technique, asthma control, and lung function, 3 months after the baseline visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30846 0
Address 30846 0
Country 30846 0
Phone 30846 0
Fax 30846 0
Email 30846 0
Contact person for public queries
Name 14093 0
Dr Iman Amin Basheti
Address 14093 0
Iman basheti
940344
Amman
11194
Jordan
Country 14093 0
Jordan
Phone 14093 0
962 799048003
Fax 14093 0
962 6 5515 017
Email 14093 0
ibasheti@usyd.edu.au
Contact person for scientific queries
Name 5021 0
Dr Iman Amin Basheti
Address 5021 0
Iman Basheti 940344
Amman
11194
Jordan
Country 5021 0
Jordan
Phone 5021 0
962 799048003
Fax 5021 0
962 6 5515 017
Email 5021 0
ibasheti@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary