Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02715219 |
| Other study ID # |
NMRR-14-1642-23836 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 25, 2016 |
| Last updated |
January 30, 2017 |
| Start date |
June 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
January 2017 |
| Source |
Clinical Research Centre, Malaysia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Asthma is an important chronic disease and a significant public health problem. Prevalence
of asthma is on the rise in all regions of the world, affecting all ages but more commonly
among children.The burden and suffering caused by chronic respiratory disease has been
identified by the World Health Organization (WHO) as a priority. In Malaysia, asthma is
among the commonest medical conditions treated in health clinics giving rise to considerable
morbidity and mortality (Bahari, Mohd Nur & Rahman, 2003).Much of the morbidity from asthma
is believed to be due to factors such as denial of having a chronic condition (GINA, 2002),
poor knowledge of the disease process and medication use (Gibson et al., 2004) , poor
understanding on the use of inhalers (Thapar, 1994) and poor self-management (Wilson et al.,
1993; Hilton, Sibbald, Anderson & Freeling, 1986). Patient education is becoming an
essential area of service provision, with our increasing population of people with chronic
diseases and conditions requiring long-term management in the community. Inadequate patient
education has been cited as a potential cause of re-attendance and the optimal format of
education is uncertain. Numerous studies worldwide have evaluated the impact of patient
education and indicated that each of the above components is amenable to asthma education
(GINA, 2002). Thus, patient education has become a key component of asthma management for
asthma patients at all age groups (Lai, et al., 2002; Harrison, 1998). Despite the means to
control asthma effectively, many asthma sufferers in Malaysia are not availing themselves of
such strategies, leading to avoidable problems that can range from frequent asthma attacks
to even death in certain circumstances. Much of the morbidity from asthma is believed to be
due to factors such as denial of having a chronic condition (Gibson, et al., 2004), poor
knowledge of the disease process and medication use (Thapar, 1994), poor understanding on
the use of inhalers (Wilson, et al., 1993) and poor self-management (Lai, et al., 2002;
Hilton, Sibbald, Anderson & Freeling, 1986). However the effectiveness of patient education
for asthma in a hospital-based setting in Malaysia has not been previously evaluated and
remains a puzzle to the researcher. With the concern the researcher would like to explore
the effectiveness of Asthma Education Programme in improvement of patients' knowledge
regarding asthma, medication adherence and inhaler technique.
Research question. Does an Asthma Education Programme result in improvement of patient's
knowledge regarding asthma disease and inhaler technique?
Research aims. i. To compare patient knowledge regarding asthma disease between intervention
and control group . ii. To compare patient inhaler technique between intervention and
control group. iii. To assess the association between patient's demographic data and health
outcomes (Knowledge and inhaler technique).
Study design. This is an experimental study a clinical trials. The period of this study is
six month which is start from July 2015 to January 2016.
Study Setting This study will be conducted in Ampang Hospital a government public tertiary
specialist hospital in Ampang, Selangor Malaysia.
Population (N). Asthmatic patients who treated in Ampang Hospital during the study period.
Target Population. Asthmatic patients who will be presented in Asthma Bay, Respiratory
Clinic or who are admitted to general medical wards for uncontrolled acute asthma attack.
Sample Size (n). The sample size of the study calculated using formula of hypothesis testing
for difference in proportions and the researcher determine effect size of 15% as significant
change, so the study need at least 129 subjects in each of arm.
Inclusion Criteria.
- Patient above age of 18 years.
- Have confirmed diagnosis of bronchial asthma in the medical record.
- Have used inhaler medication past 1 year.
Exclusion Criteria.
- Patient with significant medical comorbidity such as heart disease, chronic obstructive
pulmonary disease, chronic renal disease, stroke, psychiatric problem or inability to follow
instruction.
Sampling method. Patients who are presented in Asthma Bay, Respiratory Clinic and been
admitted to general medical ward and fulfil the inclusion criteria will be recruited to be
subject of the study. Patients' will be given an explanation about the study and written
consent will be obtained who are agreeing to participate in the study. Patients will be
randomized using simple computer randomization.
Instrument. The data for the study will be collected utilizing three adapted instrument from
previous study and the permission to use the questionnaire will be obtained through email.
Questionnaire (Part A) : Demographic data Part A consist of information about subjects
demographic data, such as age, sex, race, education level, history of childhood asthma and
number of ward admission or ED visits in the past one year. In the post test questionnaire
this part will be omitted but the subsequent layouts were similar.
Questionnaire (Part B) : Asthmatic patients' knowledge about their disease. Part B consists
of twenty close ended question, to assess respondents' basic knowledge on their disease,
medication and treatment maintenance. The questionnaire adapted from previous study by Baez
Saldana, et.al (2007). Responses will be made on selection of three choice of answer which
is "a", "b" or "c".
Questionnaire (Part C) : Multiple checklist of inhaler technique. To evaluate the
respondents' inhaler technique a single page with multiple checklist created by Vicky
Kritikos will be adapted. The checklists contain six types of inhaler technique medication,
such as Metered Dose Inhaler (MDI) with spacer, MDI, Turbuhaler, Accuhaler, Intranasal
device and Handihaler. Subjects will be asked by investigator to demonstrate how they use
the inhaler medication individually. Incorrect step of inhaler technique will be highlighted
and emphasis during the AEP.
Validity and Reliability. The validity and reliability of instruments content will be
checked by expertise panel such as a respiratory physician and pilot study will be held for
test-retest and Cronbach alpha test.
Data Collection. There are three phases involve in data collection of this study. Following
Ethic Committee approval the researcher will meet up with Head Department of Emergency
Department, Medical and respiratory physician in charge of Respiratory Clinic to notify them
about the study and formal letter explaining the purpose of the study and copy of ethical
approval will be given to them.
Phase 1: Recruitment and randomization. Patients who are fullfill the subjects inclusion
criteria in those units will be approached and subject will be given briefly explanation
about the study and written consent will be obtained. Subjects (single blind study) will be
randomized using simple computer randomization. Subjects in intervention group will be given
an appointment date to attend the an Asthma Education Programme and subjects in control
group will routinely go for the normal follow up.
Phase 2: Baseline data collection and AED session for intervention group. Baseline data
collection for subject in control group will be held in wards or Respiratory Clinic and for
subject recruited from Asthma Bay the baseline data will be collected during their routine
follow up in Respiratory Clinic. Upon completion collection of baseline data subject will be
given appointment date 4 weeks or same day clinic visit for second session of data
collection. For intervention group the baseline data collection will be held prior to Asthma
Education Programme and appointment date will be given after 4 weeks for second data
collection.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.
4. Pamphlet will be given to subjects which is prepared by Bahagian Pendidikan Kesihatan
Kementerian Malaysia containing vital information about Asthma disease and management.
Phase 3: Second data collection, After four weeks collection of the baseline data, both
group of subjects who are attending follow-up in Respiratory Clinic or by appointment given
by the researcher will be required to answer the same questionnaire and demonstrate their
inhaler technique.
Data Analysis The collected data will be reviewed by researcher and cross-check by two
independent individuals. The data will be entered into Statistical Package for Social
Science (SPSS) version 20 and will be analysed using descriptive and inferential
statistical. Questionnaire Part A will be analysed using frequency and mean statistical, the
result will be displayed in tables.To analyse the association between subjects' demographic
data and knowledge status and inhaler technique Chi-square test or independent t-test will
be used. Part B of the questionnaire containing of 20 items asking regarding respondents'
knowledge of their disease, medication and treatment maintenance. ". Responses will be made
on a three choice of answer. Each of the correct answer will be given scores 1, and 0 scores
for wrong answers. Researchers will determined the status of respondents' knowledge in two
categories, which is the total score from 15 to 20, is in category of good knowledge and
total score from one to 14 is in poor knowledge category. In order to obtain result
descriptive statistic (mean(SD) analysis will be performed. For result comparison between
statistic (mean (SD) analysis will be performed. For result comparison between intervention
and control group Independent t- test analysis will be used. Part C of the questionnaire is
to evaluate the respondents' inhaler technique using a single page with multiple types of
inhaler technique checklist such as Metered Dose Inhaler (MDI), MDI with spacer, Turbuhaler,
Accuhaler, Intranasal device and Handihaler.
Ethical Considerations The study is registered and approved by National Medical Research
Register, Malaysia.
