THE EFFECTIVENESS OF WRITTEN ASTHMA ACTION PLAN ON ASTHMA CONTROL AND QUALITY OF LIFE AMONG PAEDIATRIC ASTHMATIC PATIENTS
ABSTRACT
Background: Bronchial asthma is a chronic disease affecting the worldwide population including children. The goal of paediatric asthma management is to achieve good asthma control for the children to live a healthier life.
Objectives: To study the effect of Written Asthma Action Plan (WAAP) on the asthma control and quality of life among paediatric asthmatic patients.
Methods: An interventional study was conducted from February to June 2016 involving
120 participants, aged from 6 to 12 years old who had partly controlled and uncontrolled asthma. 61 children were allocated to the intervention group that received WAAP with standard asthma education while 59 children were in control group who were only given standard asthma education. The asthma control and quality of life scored using Asthma Control Questionnaire (ACQ) and Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was assessed at baseline and at three months. Repeated measure analysis of variance (ANOVA) was used to analyse mean score difference of both groups after the intervention.
Results: There was a significant improvement in asthma control and quality of life after three months follow up. For the analysis of ACQ, there was no significant difference of mean score for asthma control at baseline in between groups, [F(df)=1.17(1,119), P=0.282]. However, at three months, there was a significant different of mean score
between groups, [F(df)=7.32(1,119), P=0.008). The mean score (SD) in the interventional group was 0.96(0.53) and in control group was 1.21(0.49). Time-group interaction analysis using RM ANOVA showed significant different of mean score changes [F(df)=5.03(1,116), P=0.027] where lower mean score was seen in the interventional group indicating better asthma control.
For analysis of PAQLQ, there was no significant difference of mean score for quality of life baseline for both groups. Again, there was a significant mean score changes for the quality of life [F(df)=10.9(1,119), P=0.001] at three months follow up where those in interventional group scored mean (SD) score of 6.19 (0.45), and control group was 5.94(0.38). Time-group interaction using RM ANOVA showed significant mean score changes [F(df)=11.55(1,116), P=0.001] where higher score was seen in interventional group indicating better quality of life.
Conclusions: Written asthma action plan (WAAP) resulted in greater improvement of asthma control and quality of life among asthmatic children. Thus, it is advocated to be given along with standard asthma education as a part of the management of asthma in children.
TABLE OF CONTENT
TITLE
ACKNOWLEDGEMENT ii
LIST OF TABLES vi
LIST OF FIGURES vii
LIST OF APPENDICES viii
ABBREVIATIONS ix
ABSTRAK x
ABSTRACT xii
CHAPTER 1 INTRODUCTION 1
1.1 Justification of Study 6
CHAPTER 2 LITERATURE REVIEW 8
Asthma Control8
Definition of Asthma Control8
Factors Affecting Asthma Control9
Asthma Education13
Written Asthma Action Plan14
Quality of Life16
Written Asthma Action Plan on the Asthma Control and Quality of Life . 16
Delivering Asthma Education and Asthma Action Plan17
CHAPTER 3 OBJECTIVES 20
General objective20
Specific objectives20
Research Questions20
Research Hypothesis20
Operational Definition21
CHAPTER 4 METHODOLOGY 22
Trial Design22
Participants22
Interventions23
Sample size23
Randomisation24
Research Tools and Implementation25
Blinding28
Statistical analysis29
Ethical consideration29
CHAPTER 5 RESULTS 31
Sociodemographic data of studied subjects31
The effectiveness of Written Asthma Action Plan on the asthma control based on Asthma Control Questionnaire (ACQ) score32
The effectiveness of Written Asthma Action Plan on the quality of life based on Paediatric Asthma Quality of Life Questionnaire (PAQLQ) mean score36
CHAPTER 6 DISCUSSION 41
Sociodemographic Profile41
The effectiveness of Written Asthma Action Plan on the Asthma Control 47
The effectiveness of Written Asthma Action Plan on Paediatric Asthma Quality of Life50
CHAPTER 7 CONCLUSION 55
CHAPTER 9 RECOMMENDATIONS 57
REFERENCES 58
APPENDICES 68
LIST OF TABLES
Table 5. 1 Socio-demographic characteristics between asthma patient with WAAP and without WAAP 31
Table 5. 2 Comparison of ACQ score between asthmatic patients with WAAP and without WAAP based on time-group interaction 33
Table 5. 3 PAQLQ total and subdomain mean score between asthmatic patients with WAAP and without WAAP 36
Table 5. 4 Comparison of subdomain of PAQLQ score between asthmatic patients with WAAP and without WAAP based on time-group interaction 37
LIST OF FIGURES
Figure 2. 1 Conceptual Framework 19
Figure 3. 1 Asthma control assessment (Global Initiative for Asthma, 2017) 21
Figure 4. 1 Study Flowchart 30
Figure 5. 1 Profile plot of asthma control questionnaire 34
Figure 5. 2 Histogram of residual mean ACQ during baseline and follow up 35
Figure 5. 3 Scatter diagram of residual versus predicted for mean of ACQ during baseline and follow up 35
Figure 5. 4 Profile plot of PAQLQ 37
Figure 5. 5 Scatter diagram of residual versus predicted for mean of PAQLQ during baseline and follow up 39
Figure 5. 6 Histogram of residual mean PAQLQ during baseline and follow up 40
LIST OF APPENDICES
Appendix A: Maklumat Kajian 68
Appendix B: Consent Form 73
Appendix C: Assent Form 75
Appendix D: Consent for Publication 76
Appendix E: Letter of Ethical Approval 78
Appendix F: National Medical Research Registry Approval 81
Appendix G: Case report form 83
Appendix H: Asthma Control Questionnaire (Malay Form) 84
Appendix I: Paediatric Asthma Quality of Life Questionnaire (Malay Form) 87
Appendix J: Written Asthma Action Plan (Malay Form) 92
Appendix K: Asthma Education Pamphlet 93
Appendix L: Certificate of Good Clinical Practice (GCP) 94
ABBREVIATIONS
ACQ – Asthma Control Questionnaire ANOVA – Analysis of Variance GINA - Global Initiative for Asthma
HSNZ – Hospital Sultanah Nur Zahirah, Kuala Terengganu MDI – Metered dose inhaler
PAQLQ – Paediatric Asthma Quality of Life Questionnaire PEFR – Peak Expiratory Flow Rate
QoL – Quality of Life
RM ANOVA – Repeated measure analysis of variance SPSS – Statistical Package for Social Sciences
USA – United States of America WAAP – Written Asthma Action Plan
CHAPTER 1
INTRODUCTION
Asthma is one of the health burden affecting adults in every country including children (Global Initiative for Asthma, 2017). Globally, it was estimated that asthma accounted for 250,000 deaths per year where more asthma death was seen in countries where essential medications of asthma are not easily accessible (World Health Organization, 2007). Worldwide prevalence of asthma in 2007 as reported by the World Health Organisation was 300 million people. It was estimated that there will be 100 million of newly diagnose asthma in the next decade (World Health Organization, 2007). As reported by United States National Health Interview Survey in 2014, it showed that the prevalence of bronchial asthma was increasing in trend particularly among paediatric and adolescent age groups. The prevalence of asthma of those under 18 years old in the United States in 2015 was 6.2 million of population (United States Department of Health and Human Services, 2015). According to International Study of Asthma and Allergies in Childhood (ISAAC) III, even though overall difference in prevalence of asthma worldwide is reducing particularly in western countries, but the prevalence of younger children age of 6-7 years old to be diagnosed with asthma is increased (Neil Pearce, 2007).
In Malaysia, the prevalence of childhood asthma in 1995 was about 10% as per survey conducted by ISAAC phase I study (The Global Asthma Network, 2014). However, this may not be a true representative of the burden of childhood asthma in Malaysia as the survey was only conducted in three centres in Malaysia. Better reflection on the prevalence of childhood asthma in Malaysia can be obtained from 2006 National Health Morbidity Survey (NHMS III), where it showed that the prevalence of childhood asthma was 7.1% (Institute Public Health, 2008). The prevalence of asthma in younger age group was higher among male and adolescent
age group and it was associated with living in an urban or rural area (Institute Public Health, 2008). For example, a study conducted in Selangor which is an urban area in 2010 revealed that the prevalence of childhood asthma is 24%, which is higher among Malays compared to Indians and Chinese population (Roslan et al., 2011). However, different study conducted among aborigines in rural Pahang in 2007 till 2009 showed that the prevalence of childhood bronchial asthma is only 1.5% (Ngui et al., 2011).
Although the prevalence of childhood asthma in Malaysia was about 7% to 24% depending on the different areas of the country, the control was not optimised. Among paediatric asthmatic patients, 65.2% of them were having persistent asthma symptoms (Institute Public Health, 2008). They posed poorer morbidity due to asthma compared to those in the US. For example, about 53% of Malaysian asthmatic children will miss school due to asthma attack, with average day loss of 3.6 days as compared to those in US which was 48% (Institute Public Health, 2008; Prevention, 2013). The unscheduled doctor visit due to exacerbation of asthma was about 82%, in which about one-third of them visit emergency department for acute exacerbation of asthma. More than one-fifth of them reported limitation of physical activity due to the illness (Institute Public Health, 2008). Data published by World Health Organisation in May 2014 showed the Malaysia’s prevalence of mortality due to overall asthma was 1.3% of total deaths even though it is a preventable cause of death.
Bronchial asthma is a heterogenous disease, caused by chronic reversible airway obstruction. The mechanism is a rather complex process where it involves airway inflammation and bronchial hyper-responsiveness leading to intermittent airflow obstruction, dyspnoea, chest tightness, wheezing, and cough (Global Initiative for Asthma, 2017). The asthmatic attack among paediatric age group usually triggered
by respiratory tract infection. Other triggering factors are cold temperature, exercise, emotional liability, allergens, and air born irritants such as mould, animal fur, pollen, smoke and house dust mites (Clancy and Blake, 2013). Predictors of development of asthma in paediatric include family history of asthma, personal history of allergy, and associated comorbidities such as allergic rhinitis, sinusitis, adenoidal hypertrophy, and urticaria. (Dan et al., 2016).
When an asthmatic patient is exposed to triggering factors such as dust, smokes, cold weather, or viral infection of the respiratory tract, it will trigger the inflammatory cells infiltration to the airways which includes eosinophils, neutrophils, lymphocytes and mast cells (National Heart, 2007). These inflammatory cells will release inflammatory mediators causing bronchial smooth muscle constriction causing bronchial airway narrowing and subsequently airflow limitation which causing cough and wheezing. As the inflammatory process becomes more persistent and progressive, there will be remodelling of the airway causing permanent change in the airway, for example, thickening of sub-basement membrane, sub-epithelial fibrosis, airway smooth muscle hypertrophy, blood vessel proliferation and mucous gland hyperplasia and hypersecretion (National Heart, 2007).
Environmental factors play important role in asthma trigger and exacerbation. It was hypothesized that ‘Western’ environment is a precipitating risk factor for development of asthma, indicating urbanisation and reduction of childhood exposure to ‘good’ microorganism that is protective against allergies and asthma (Chung, 2016). A local study conducted in Universiti Kebangsaan Malaysia Medical Centre (UKMMC), Kuala Lumpur in 2015 showed there was an increased risk of bronchial asthma in those who exposed to lorry fume, congested roads and indoor carpet indicating environmental factors contributing to development of asthma (Idris et al.,
2016). This reflected why the burden of asthma is higher in more urbanised and industrialised area as compared to rural areas (Institute Public Health, 2008).
Asthma is diagnosed mainly from the history of variable respiratory symptoms and confirmation of airflow limitation (Global Initiative for Asthma, 2017). The respiratory symptoms include wheeze, shortness of breath, chest tightness and cough. In paediatric asthma case, investigations such as spirometry, exhaled nitrite oxide and skin prick test are not usually carried out. If the airflow limitation is to be confirmed, the response to bronchodilator therapy is taken as improvement of FEV1 of more than 12% or improvement of PEFR of 20%. However, the changes may not be seen in mild asthmatics (Ministry of Health Malaysia, 2014 ).
Goals of asthma therapy in children are to maintain their normal activities including participation in exercise and sports events, prevent absentees from school, no visit to emergency department and hospitalisation due to exacerbation of asthma, no side effects of the medications, hence to improve morbidity and mortality (Ministry of Health Malaysia, 2014 ). This goal can be achieved by compliance with medical care and follow ups. This is a difficult tasks to be accomplished by heath care providers as NHMS III showed that 69% of asthma patients did not have proper follow ups (Institute Public Health, 2008). Asthmatic status among the patients need to be monitored in term of control and compliance. Both care takers and patients should be educated during the follow ups (Ministry of Health Malaysia, 2014 ). Thus, the importance of compliance to the medications and follow ups among asthmatic patients should be emphasized to the care takers.
Management of asthma should be individualised. Pharmacological management of asthma basically divided into two which are anti-inflammatory and
bronchodilator (Global Initiative for Asthma, 2017; Ministry of Health Malaysia, 2014
). Anti-inflammatory medication used in asthma mainly corticosteroid and leukotriene inhibitors. Based on the asthma control, the pharmacological management can be either step up or step down according to the stepwise approach of mediation adjustment as proposed by Global Initiative of Asthma (GINA) (Global Initiative for Asthma, 2017). However, the problem with the use of corticosteroid in paediatric asthmatic patients is reduction of the rate of growth in children (Philip, 2014). The growth rate reduction depends on the dose and the type of inhaled corticosteroid (ICS) molecules used (Philip, 2014). However, the slower growth rate was not cumulative beyond the first year of using ICS, thus the use of ICS outweighs the harm to achieve good asthma control (Zhang et al., 2014). Thus, every asthmatic child who use inhaled corticosteroid, it is a good routine by physician to monitor the growth of the children.
Other than pharmacotherapy, asthma education is also vital in controlling asthma and reducing the severity of an exacerbation. It empowers patients and caretakers in active management of asthma. Asthma education includes education on how to recognise sign and symptoms of asthma, avoid the triggering factors, education on physical activities, information on the medications and individualised written asthma action plan (Ministry of Health Malaysia, 2014 ).
Asthma action plan is introduced as an integral part of asthma self-care management (Global Initiative for Asthma, 2017; Ministry of Health Malaysia, 2014 ). It is an individualised plan that divides the asthma severity based on the symptoms. By symptoms recognition, caretakers can initiate the rescue therapy at home if needed. It empowers patients and caretakers in initiating acute asthmatic attack at home (Khan et al., 2014). It improves caregivers’ understanding on the use of inhalers during exacerbation before coming to emergency department for treatment. A study in
Singapore showed that the understanding of the asthma and the use of devices are better among those educated with asthma action plan, and the decision to visit the physician does not change (Ngiap Chuan Tan, 2013)
1.1 Justification of Study
Many asthmatic children in Malaysia had persistent asthma symptoms despite availability of the treatment (Institute Public Health, 2008). Poor compliance and poor knowledge are among the contributory factors leading to persistent symptoms (Rakhee Yadav, 2014). Asthma control as stated by many literatures can be achieved by adherence to medications and asthma education. The use of asthma action plan improved parental knowledge and confidence in managing their children with asthma attack (Ngiap Chuan Tan, 2013). Both parties (patients and parents) can recognise the early exacerbation episodes at home and prompt initial management at home can be commenced, thus reducing and improving the severity and morbidity of the illness.
Even though asthma action plan is advocated in many guidelines, the positive effect on it is not well established. A study in Trinidad comparing paediatric asthmatic patients receiving standard asthma care versus asthma action plan did not find significant improvement of the asthma outcomes in term of asthma symptoms and morbidity (Khan et al., 2014). A local study in a tertiary centre in Kuala Lumpur unable to demonstrate a significant impact of asthma action plan on the asthma control, quality of life and unscheduled doctors visit among paediatric asthmatic patients (Wong et al., 2013). However, the study was done among elder paediatric asthmatic patients, with mean age group was 12 years old. The study included all
asthmatic patients regardless of the severity of asthma where many of their patients had controlled asthma at baseline of study.
Since there was conflicting of evidence on the use of written asthma action plan (WAAP), thus this study was conducted to assess and promote on the effectiveness of WAAP in achieving better asthma control and improving quality of life among partly controlled and uncontrolled bronchial asthma among younger age children.
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