None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.