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Influence of patientsí education on their Asthma control


- candidate number15291
- NTR NumberNTR4126
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2013
- Secondary IDs 
- Public TitleInfluence of patientsí education on their Asthma control
- Scientific TitleInfluence of patientsí education on their Asthma control
- ACRONYMN/A
- hypothesisThe aim of this study is to evaluate the level of asthma control of patients seen at the pneumology out-patient clinic of the University Hospital of Brussels and to determine if education on the inhalation technique and information about their therapy could influence asthma control.
- Healt Condition(s) or Problem(s) studiedAsthma control, Education, Inhalation technique
- Inclusion criteriaa) Patients have to be 18 years or older,
b) Diagnosed with asthma (recorded diagnosis in accordance with GINA criteria for asthma) for more than one year and
c) Receiving a maintenance therapy with Inhaled Cortico Steroids. (ICS)
- Exclusion criteriaa) Prior enrollment in the study and
b) Patients who canít read or write Dutch, French or English.
c) Recent (within six weeks) an asthma exacerbation
d) current smokers with an history of 5 pack years
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate31-dec-2014
- Target number of participants100
- InterventionsOne out of two randomized patients will get a brief specific add on session for about 10 minutes, of inhalation education and information about their therapy
- Primary outcomeAs primary end point we will use the asthma control test (ACT), Asthma Control Questionnaire ACQ Ėscore
- Secondary outcomesecondary common lung function parameters Forced expiratory volume in one second(FEV1) and fraction of expired nitric oxide (FeNO) pre and post education and instructions.
- TimepointsDuring the same session we will ask all patients to return to the out-patient clinic after 3 months at their normal follow-up visit for visit 2.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Daniel Schuermans
- CONTACT for SCIENTIFIC QUERIES Daniel Schuermans
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryBackground: Despite the availability of effective treatments aimed at controlling asthma symptoms, up to 50% of patients with asthma remain poorly controlled. Several studies in the US, UK and other European countries among adults and children with asthma suggest that education and information of an asthmatic patient is the cornerstone of therapy adherence. Successful asthma management is 10% medication and 90% education.
Objective: The aim of this study is to evaluate the level of asthma control of patients seen at the pneumology out-patient clinic of the University Hospital of Brussels and to determine if education on the inhalation technique and information about their therapy could influence asthma control.
Methods: After their usual normal consultation procedure, including routine lung function measurements, patients will be asked to participate in this educational study. After informed consent is obtained, subjects are interviewed to determine their demographic characteristics, asthma history, asthma control by the validated Asthma Control Test score (ACT)17, Asthma Control Questionnaire (ACQ)23 and knowledge about their disease and treatment. After completing the survey, routine actions on consultation pneumology will continue: including a supplementary check of inhaler technique. One out of two randomized patients will get a brief specific add on session for about 10 minutes, of inhalation education and information about their therapy, eg. medication use (group one) . The other group (group two) will continue their usual normal consultation procedure. All patients will be asked to return after 3 months at their normal next visit, to the out-patient clinic to redo routine lung function measurements, asthma control questionnaires and check of inhaler technique. Acquired data will be statistical analyzed.
- Main changes (audit trail)
- RECORD19-aug-2013 - 2-sep-2013


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