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The Effect of an AEP on Patient's Knowledge Regarding Asthma Disease and Inhaler Technique: RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715219
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Lilyiana Binti Pengui, Clinical Research Centre, Malaysia

Brief Summary:

Asthma is an important chronic disease that causes a significant public health problem and the commonest medical conditions treated in health clinics giving rise to considerable morbidity and mortality. Several studies suggested that improvement of patient knowledge has become a key component of asthma management. In the study setting the education material for Asthma patient is available however the proper cannel to deliver it to patient remains a puzzle to the researcher, therefore this study is trying to close the gap between Asthma education material and patient.The aim of the study is to investigate the effectiveness of an Asthma Education Program (AEP) result in improvement of patient's knowledge, medication adherence and inhaler technique.This is an experimental study a clinical trials. Data will be gathered utilising three an adapted instrument to assess patient knowledge of their disease, medication adherence and inhaler technique. Patients who are came to Asthma Bay in Emergency Department, Respiratory Clinic for routine follow up and admitted to ward will be recruited as study subjects. Subject who are agree to enrol in the study will be randomized into intervention and control group. Subjects in intervention group will be undergone one session of an AEP, however there are no intervention for control group but continue routinely follow up in Respiratory Clinic. To obtain the study result descriptive and inferential statistical analysis will be performed. To analyse the statistical significant of the change in patients' health outcome the pre and post of AEP independent t-test or chi-square test will be used.The expected finding of this study is to determine the effectiveness of AEP result in of patients' knowledge regarding asthma disease, medication adherence and inhaler technique, pre and post of AEP.

Keywords: asthma, asthma education program.


Condition or disease Intervention/treatment Phase
Chronic Respiratory Disease Other: Asthma Education Programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of an Asthma Education Programme on Patient's Knowledge Regarding Asthma Disease and Inhaler Technique: Randomized Control Trial
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: intervention group
Subjects in intervention group will be given an appointment date to attend the an Asthma Education Programme.
Other: Asthma Education Programme
The Asthma Education Programme consists of four items. 1. Education video for Asthmatic patient adapted from Info Sehat by Bahagian Pendidikan Kesihatan Kementerian Kesihatan Malaysia which is explaining about Asthma disease, medication and patient responsibility in Asthma management. 2. Small group discussion with subject's to help them understand better in Asthma management. 3. Face to face demonstration and teaching of inhaler technique by three trained nurse in small group range of two to five subjects. At the end of the AEP subject will received a 4. Pamphlet will be obtain from Patients' Education Unit in Ampang Hospital containing vital information about Asthma disease and management. The intervention estimated will take 1 hour to 1 hour 30 minutes to be completed.

No Intervention: control group
Subjects in control group will routinely go for the normal follow up in Respiratory Clinic without receive any intervention.



Primary Outcome Measures :
  1. The difference of subjects' knowledge score as assessed using a questionnaire. [ Time Frame: 4 weeks ]
    To compare patient knowledge status regarding asthma disease between two groups .


Secondary Outcome Measures :
  1. The difference of patient inhaler technique status as assessed using a checklist. [ Time Frame: 4 weeks ]
    To compare patient inhaler technique between two groups.

  2. The association between patient's demographic data and knowledge status, medication adherence and inhaler technique. [ Time Frame: 4 weeks. ]
    To compare the association result between two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have confirmed diagnosis of bronchial asthma in the medical record.
  • Have used inhaler medication past 1 year.

Exclusion Criteria:

  • Patient with significant medical comorbidity
  • heart disease
  • chronic obstructive pulmonary disease
  • chronic renal disease
  • stroke
  • psychiatric problem or inability to follow instruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715219


Sponsors and Collaborators
Clinical Research Centre, Malaysia
Investigators
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Principal Investigator: Lilyiana Pengui, nursing Clinical Research Centre, Malaysia
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Responsible Party: Lilyiana Binti Pengui, Principal investigator, Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT02715219    
Other Study ID Numbers: NMRR-14-1642-23836
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases