ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

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]

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]

The primary outcome measure is inhaler technique score (out of 9), assessed 3 months after the educational intervention (inhaler technique education).

Timepoint [1]

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]

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]

Patients will be assessed at baseline and 3 months following baseline.

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

114

Accrual to date

Final

Recruitment outside Australia

Country [1]

Jordan

State/province [1]

Amman

Funding & Sponsors

Funding source category [1]

University

Name [1]

Applied Science University

Address [1]

Applied Science University Private
Shafa Badran
PO Box 111931
Amman
Jordan

(we do not include street names in the addresses in Jordan)

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Jordan Ministry of Health

Ethics committee address [1]

P.O Box 86
Amman, 11118, Jordan

Ethics committee country [1]

Jordan

Date submitted for ethics approval [1]

16/04/2009

Approval date [1]

11/05/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Iman Amin Basheti

Address

Iman basheti
940344
Amman
11194
Jordan

Country

Jordan

Phone

962 799048003

Fax

962 6 5515 017

ibasheti@usyd.edu.au

Contact person for scientific queries

Name

Dr Iman Amin Basheti

Address

Iman Basheti 940344
Amman
11194
Jordan

Country

Jordan

Phone

962 799048003

Fax

962 6 5515 017

ibasheti@usyd.edu.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

Source	Title	Year of Publication	DOI
Embase	Interventions to improve inhaler technique for people with asthma.	2017	https://dx.doi.org/10.1002/14651858.CD012286.pub2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically