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

NCT02715219 | Completed DMC

• 1 other identifier: NMRR-14-1642-23836
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• The difference of subjects' knowledge score as assessed using a questionnaire.

  To compare patient knowledge status regarding asthma disease between two groups .

  4 weeks

Secondary Outcomes (2)

• The difference of patient inhaler technique status as assessed using a checklist.

  4 weeks

• The association between patient's demographic data and knowledge status, medication adherence and inhaler technique.

  4 weeks.

Study Arms (2)

intervention group

EXPERIMENTAL

Subjects in intervention group will be given an appointment date to attend the an Asthma Education Programme.

Other: Asthma Education Programme

control group

NO INTERVENTION

Subjects in control group will routinely go for the normal follow up in Respiratory Clinic without receive any intervention.

Interventions

Asthma Education Programme OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Officials

• Lilyiana Pengui, nursing

  Clinical Research Centre, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 22, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share