Effect of Implementing an Educational Module About Inhaler Use on Severity of Dyspnea and Adherence to Inhalation Therapy Among Patients with Chronic Obstructive Pulmonary Disease

One of the most important routes for medication administration to treat chronic obstructive pulmonary disease patients is the inhaled one. If this method is not proper, medications will not be effective. The aim of this study was to determine the effect of implementing an educational module about inhaler use on severity of dyspnea and adherence to inhalation therapy among patients with chronic obstructive pulmonary disease. A purposive sample of 140 patients with COPD was selected and divided randomly and alternatively into two equal groups, 70 in each. The study was conducted at Chest department and Medical outpatient clinics of Menoufia University and Shebin El-Kom Teaching Hospitals. Five tools were utilized for data collection: Structural interview questionnaire, Bristol COPD knowledge questionnaire, Pressurized metered dose inhaler performance observational checklist, Shortness of breath questionnaire and Morisky Medication adherence scale. Results: 62.9% of study group and 54.3% of control group complained of severe dyspnea pre education, while 44.3% of study group and 54.3% of control group still complained of severe dyspnea one month post education. The improvement of dyspnea among study group than control group was not significant. However medication adherence was significantly improved among study group compared to control group post education. Conclusion: educational module about inhaler use significantly led to improve medication adherence and decrease dyspnea severity however the difference in dyspnea severity among both groups is not significant. Recommendations: Patient's education about correct inhaler use should be ongoing process for all COPD patients and the correct use of inhaler should be observed throughout patient's life.


Introduction
Chronic obstructive pulmonary disease (COPD) is a major health condition that characterized by irreversible progressive air flow limitation that leads to increase worldwide prevalence, morbidity and mortality [1]. In this condition, the airway becomes damaged making it increasingly difficult for air to pass in and out [2]. Moreover it affects the quality of life and economic status for those patients [3].
Most of the available information about COPD is from highly income countries. However, accurate epidemiological data are difficult and expensive to collect. In 2005 WHO estimated that, there are 210 million people diagnosed with COPD and three million patients were died of COPD. These deaths represent 5% of all deaths globally but approximately 90% of them occur in low income countries. In 2002, COPD was the fifth leading cause of death that will become the third cause worldwide in 2030. [4,5]. According to statistics by country for COPD (2013), the extrapolation of undiagnosed prevalence rate of COPD in Egypt is 4,197,651 and the diagnosed prevalence rate is 3,777,886 [6]. COPD is highly associated with over exposure to environmental factors especially tobacco smoke that is responsible about 80 to 90% of cases, occupational dust and air pollution [7]. Cough, sputum production and dyspnea on exertion as well as fatigue and sleep disturbances are the primary symptoms of COPD [1,8]. It also affects patients' physical functions, working and recreations activities, and emotional status as well as sexual relations [9].
Dyspnea is the subjective experience of unpleasant discomfort with breathing. It is a cardinal symptom of chronic obstructive pulmonary disease (COPD). The more progress, the more its severity and magnitudes that have negative impact on patient's abilities and quality of life to the extent that patients become isolated, often describing themselves as existing rather than living. Refractory dyspnea is a common and difficult symptom to treat in patients with advanced COPD. The most important question about the ideal management is whether various therapies are effective or not [10,11].
The most important line of management strategies for COPD are risk reduction such as smoking cessation and proper vaccination for Influenza and Pneumococcus, symptoms relief and prevention of exacerbations [12]. These can be achieved by pharmacological management especially bronchodilator to relieve bronchospasm and reduce airway obstruction, corticosteroids to improve symptoms and oxygen therapy to prevent acute dyspnea [1]. Medications can be given by inhalation or orally, however the inhaled rout is the preferred one because by this route, patients may need low dose with faster action and fewer adverse effects. Moreover, medications go directly to the target region of respiratory tract [13,14]. For this reason the inhaled route is the route of choice for the treatment of most bronchial diseases especially COPD. The inhalation technique influences the drug deposition in the lung and enhances the effectiveness of the treatment for the patients with COPD although inhalation technique is often incorrect in many COPD patients [15].
There are many factors that affect the effectiveness of inhaled drugs such as patient's age, sex and education, duration of the disease, type of inhalers and correct inhalation technique [16]. However majority of COPD patients' incorrectly perform the inhalation technique. Many clinical studies reported that up to 90% of those patients show incorrect technique. This may lead to decrease disease control, increase the absenteeism from work or school, unnecessary increase in medication dosage, increase risk of side effects, non adherence to inhaled medication and exacerbations manifestations especially deterioration of dyspnea that requires oral corticosteroid treatment [17]. Many COPD patients are non adherent to the inhaled drugs so mortality rate is susceptible to increase more than twice among those patients compared to patients who adhere to the inhaled medications [18,19].
Although COPD cannot be cured, optimal management provides symptom control, slows progression of the disease, and may improve the quality of life. Management of COPD becomes suboptimal due to poor adherence to evidencebased guidelines and under diagnosis or when patients fail to adhere to prescribed treatment regimens [20,21]. Adhering to inhaled medications is one of the most important factors for managing COPD in both clinical and ambulatory settings. In a recent study, it was shown that there was a significant decrease in the frequency of dyspnea, cough, sputum purulence or wheeze [18].
Moreover in a previous study, the instructions given repeatedly to COPD patients about inhalation technique contributed to adherence to therapeutic regimen that had a significant effect on health status [18]. Regular evaluation of inhalation technique is important to optimize treatment effectiveness and the inhalation technique can be significantly improved by brief instruction given by any trained health care personal on correct inhaler technique [17]. So this study aimed to determine the effect of implementing an educational module about inhaler use on severity of dyspnea and adherence to inhalation therapy among patients with chronic obstructive pulmonary disease.

Aim of the Study
The aim of the study was to determine the effect of implementing an educational module about inhaler use on severity of dyspnea and adherence to inhalation therapy among patients with chronic obstructive pulmonary disease.

Research Hypotheses
The following research hypotheses were formulated to achieve the aim of the study: a. Patients who follow educational module instructions about inhalation technique show a significant reduction in severity of dyspnea than patients who don't. b. Patients who follow educational module instructions about inhalation technique exhibit medication adherence than patients who don't.

Design
A quasi experimental research design was utilized to achieve the aim of this study.

Setting
The current study was conducted at Chest department and Medical outpatient clinics of Menoufia University and Shebin El-Kom Teaching Hospitals.

Subjects
A purposive sample of 140 patients with chronic obstructive pulmonary disease was selected by using the following power analysis equation:-Adherence to Inhalation Therapy Among Patients with Chronic Obstructive Pulmonary Disease

Power Analysis
The patients to be selected were determined by using the following equation: n= (z2×p × q)/D2. Since the actual prevalence of COPD was 10%, and a value of 0.025 was chosen as the acceptable limit of precision (D). Based on these assumptions, the sample size was estimated to be 140 patients. They were divided alternatively into two equal groups 70 patients in each.
Study group (1) received a detailed education and training about correct inhalation technique along with routine medical care such as administration of oxygen therapy and nebulizer.
Control group (2) was exposed to routine medical care only.

Inclusion Criteria
Subjects were considered eligible for the study if they had the following criteria: Adult conscious patients. Under inhalation therapy. Complained of dyspnea. Carry regular visits to medical outpatient clinics every one to three months. Free from any associated disorders.

Sampling Technique
The sample size was determined and calculated using EPI info program and it was estimated to be 138 patients at coefficient interval 99%. The researchers increased the sample size to 140 patients.

Tools
For the aim of the study and to collect the necessary data, five tools were utilized by the researchers. These tools were as follow:

Tool I: Structured Interviewing Questionnaire
It was constructed by the researchers to collect data about biosociodemographic data. It covered the following two parts: Part one: Sociodemographic Data. It was comprised of seven items related to patients' age, sex, marital status, educational level, occupation, working hours and home status. Part two: Medical data. It was concerned with information related to medical data such as smoking status, patients' present complaints, use of oxygen, history of inhaler use, previous hospitalization, family history of lung diseases and environmental factors that may increase the intensity of symptoms.

Tool II: Bristol COPD Knowledge Questionnaire (BCKO)
It was developed by White et al., (2006) [22]. The questionnaire was translated into Arabic, back translated and linguistically validated then utilized by the researchers to assess patient's COPD related knowledge. It consisted of sixty five statement about COPD symptoms (such as ankle edema, fatigue, chest pain, dyspnea, sputum and rapid weight loss), manifestations of chest infection, benifits of exercises for COPD, importance of smoking cessation, vaccination and medications especially inhaled bronchodilators, antibiotics and chorticosteroides.
Scoring system: Each item was given a score of one if the answer is correct and zero if the answer is wrong or don't know, then all scores were summed. The possible score ranged from zero to sixty five and the patients were categorized into two groups based on their scores: A BCKO score of 28 or more was considered high knowledge, while a score of less than 28 was considered low knowledge score.
Reliabilty   [23] tested the reliability of the english version of the questionnaire, it was demonstrated to be 0.82 with strong test re-test agreement. while the researchers used a test re-test method to test reliabilty of the questionnaire after translation, it was 0.84.

Tool III: Pressurized Metered Dose Inhaler
Performance Observational Chicklist It was developed by the researchers according to the guidelines of the inhaler manufacture to assess patient's performance of pressurized metered dose inhaler such as removing the cap, holding inhaler uprightly, breathing out gently, putting mouthpiece between teeth and breathing in slowly through mouth, etc. The number of chicklist's steps were eleven. The patient was given one degree for each step that was performed accurately or zero for inaccurate technique or skipped step then all degrees were summed. Subjects were considered to have good performance if he had seven degrees or more. The more the degree, the higher the performance.

Tool VI: Shortness of Breath Questionnaire
It was developed by Eakin et al., (1998) [24] and used by the researchers to rate patient's breathlessness and assess which physical activity that may percipitate breathlessness. It consisted of 24 listed phsical activities to be assessed if it perciptitate dyspnea or not such as shortness of breathing at rest, at walking on a level at own pace, walking upstairs, while eating, dressing, doing dishes, and shopping.
Scoring system: the questionnaire is a six point likert scale rated from zero to five in which: Zero is not at all breathlessness 1. is very mild breathlessness 2. is mild breathlessness 3. is avarage breathlessness 4. is severe breathlessness 5. is maximum breathlessness or unable to do the activity because of breathlessness. The total scores were summed that ranged from zero to one hundered twenty with higher score indicated inability to do any activity because of breathlessness. Reliability: Tabberer et al., (2015) [25] tested the reliability of the questionnaire. They found that this questionnaire had high internal consistency (Cronbach's alpha = 0.936) with high test re-test reliability (Pearson's correlation coefficient = 0.86). Morisky et al., (1986) [26] and used by the researchers to assess patient's adherence to the prescribed inhaled medications. It consisted of eight questions about adherence to the prescribed medications such as did patient sometimes miss the medication, did he/she stopped taking the medication for reason other than forgetting or have the patient stopped taking medication without telling the doctor.

Tool V: Morisky Medication Adherence Scale (MMAS) It was developed by
Scoring system: each item was given a score of zero if patient adhere to the prescribed medications and one for nonadherence, then all scores were summed given a score of: Zero means high adherence 1-2 means medium adherence 3-8 means low adherence Reliability: Moharamazad et al., (2015) [27] told that a test re-test reliability showed good reproducibility (r= 0.94)

Methods
(1) Data was collected from the beginning of March 2014 to the end of August 2015.
(2) An official approval was obtained from hospitals' director and the head nurses of the Chest department and Medical outpatient clinics after an explanation of the aim of the study.

Tools Development
The first and third tools were developed by the researchers after extensive review of the relevant literature. While the second tool was developed by White et al., (2006) [22] and translated into Arabic by the researchers, fourth one developed by Eakin et al., (1998) [24] and the fifth tool developed by Morisky et al., (1986) [26].
First and third tools were tested by a panel of five experts in the field of Nursing and Medicine to determine its content validity, relevance and completeness. While the second tool was translated into Arabic, back translated and linguistically validated by the same panel of experts.
The reliability of the first and third tools were tested by using a test re-test method and the 4 Pearson correlation coefficient. It was 0.91 for tool I and 0.94 for the third tool. Also the second tool was tested for reliability by the researchers after translation into Arabic by using a test re test method. It was 0.84. (3) A formal consent to participate in this study was obtained from all participants after explaining the aim of the study and they were assured that all collected data would be absolutely confidential and only will be used for the study' aim. The researchers emphasized that participation in the study is entirely voluntary and anonymity of the patients were assured through coding data. Subjects were also informed that refusal to participate in the study would not affect their care.

Pilot Study
A pilot study was conducted prior to data collection on 14 patients (10%) to test all tools for clarity, objectivity, relevance, feasibility and the applicability of the tools. Also it was conducted to identify any problem associated with administering the tools and measure the time needed for data collection then the necessary modifications were carried out accordingly. Data included in pilot study was excluded from the current study

Data Collection
The patients who fulfilled the inclusion criteria were selected and divided randomly and alternatively into two equal groups Study group (1) received a detailed education and training about correct inhalation technique along with routine medical care such as administration of oxygen therapy and nebulizer. Control group (2) was exposed to routine medical care only.
The study was conducted in four consecutive phase. These phases were:-

Assessment Phase
The first interview was carried out by the researchers for each participant of both groups for collecting baseline data about sociodemographic and medical data, COPD related knowledge, severity of dyspnea, and medication adherence level. The interview carried out often in the patient's room with hospitalized patients or in the waiting area of outpatient clinics if he/she wasn't hospitalized. It took about 25 to 30 minute using tool I, tool II, tool VI and tool V. Then the researchers utilized the third tool (observational checklist) to assess each participant of both groups for their performance of inhaler use.

Planning Phase
Based on assessment phase and extensive literature review [2,6]

Evaluation Phase
Evaluation of all subjects of both groups was done twice during the study period. The first time post two weeks from last session and the other after one month using all tools. A comparison between both groups was carried out to determine the effect of education about inhaler use on severity of dyspnea and adherence to inhalation therapy among patients with chronic obstructive pulmonary disease.

Statistical Analysis
The collected data were organized, tabulated and statistically analyzed using SPSS software (Statistical Package for the Social Sciences, version 16, SPSS Inc. Chicago, IL, USA). For quantitative data, the range, mean and standard deviation were calculated. For qualitative data, comparison between two groups and more was done using Chi-square test (χ 2 ). For comparison between means of two groups of parametric data of independent samples, student t-test was used. For comparison between more than two means of parametric data, F value of ANOVA test was calculated. Correlation between variables was evaluated using Pearson's correlation coefficient (r). Significance was adopted at p<0.05 for interpretation of results of tests of significance [28]. Table 1 illustrated that the mean age for study group was 57.77±12.43 years and for control group was 56.77±11.37 years. More than three fourths of both study and control groups were married (78.6% and 87.1% respectively). About one third of them had secondary education (37.1% for study group and 30.0% for control group). Regarding working hours, about half of both study and control groups (59.3% and 48.4% respectively) worked eight hours per day. In relation to the home condition, it was show that the majority of both groups had sun in their houses (85.7% and 88.6% respectively) and proper room ventilation (84.3% and 88.6% respectively). Also about two thirds of both groups had sewage (68.6% and 62.9% respectively. Lastly about one third of study group (31.4%) and more than half of control group (51.4%) gave up smoking. Table 2 revealed that about two thirds of both study and control groups (62.9% and 71.4% respectively) visited output clinic once per week. More than one third of both groups (42.9% and 37.1%) complained of productive cough, wheezing, and dyspnea. All subjects of both groups (100%) used oxygen during attack. Regarding duration of inhaler use, the majority of both groups (80.0% and 82.9% respectively) used the inhaler from two or more years. All of them (100%) received training about inhaler use but none of them (0.0%) followed up this training. As regard family history of lung diseases, the majority of both groups (81.4% and 87.1% respectively) didn't have positive family history. Smoke was the most aggravating factors for the disease manifestations about one third of both groups (32.9% and 41.4% respectively). Table 3 showed that about one quarter of both study and control groups (24.3% and 25.7% respectively) had low knowledge score at pre intervention. These scores were improved after two weeks and one month post intervention. 100% of study group and 74.3% of the control group had a high knowledge score two weeks and one month post intervention. Statistically significant differences were existed between both groups two weeks and one month post intervention. Figure 1 revealed that mean total performance score of inhaler use for study group was significantly improved throughout the study period from 6.06 ± 0.63 pre interventions to 9.71 ± 1.10 two weeks and one month post intervention. While the mean total performance score for control group remained stable all over the study period at 6.13 ± 0.74. Statistical significant differences existed between both groups two weeks and one month post intervention at (p = 0.0001). Table 4 demonstrated that about two thirds of study group I (62.9%) and more than half of control group II (54.3%) complained of severe dyspnea, while one month after education only 44.3% of study group still complained of severe dyspnea compared to 54.3% of control group with insignificant differences existed between both groups. Table 5 showed that only 4.3% of study group adhere moderately to medication pre intervention that was significantly improved to 47.1% two weeks and one month post intervention. But control group remained stable all over the study period with 10% of them had moderate adherence to medication. There were statistical significant differences between both groups two weeks and one month post intervention. Table 6 revealed that there was statistical significant difference between dyspnea severity scores in relation to disease duration among study group. Table 7 showed that no statistical significant differences were existed between medication adherence levels in relation to selected sociodemographic characteristics among study and control groups. Table 8 shows that a negative correlation was found among dyspnea severity score and knowledge score for study group post intervention.    Table 5. Levels of medication adherence among both studied subjects pre, two weeks and one month post-education (n=140).

Morisky medication adherence
The studied COPD patients (n=140)  Table 7. Mean scores of medication adherence pre education among studied subjects in relation to sociodemographic data and duration of disease (n=140).

Discussion
The inhaled medications are the corner stone of therapy among patients with obstructive lung diseases and the inhaler is the only device for administrating the medication effectively which allows the drugs to be highly deposited in the lungs and it also minimizes the systemic adverse drug reaction [29].
Education of patients and their families has a major concern in recent years. This has been motivated by patient's needs for knowing more about their diseases so any health care personal should consider the self management as an important aspect for patient's recovery [22]. New evidence reported that control of COPD symptoms can be improved by brief verbal instructions and demonstration of correct inhaler technique [17].
Biosociodemographic characteristics of studied subjects: The results of present study found that the mean age of study group was 57.77±12.43 years and 56.77±11.37 years for control group. This finding is in line with Salah et al., (2013) who stated that the mean age of their sample was 55±5.7 years [30] and Tel et al., (2012) who found that the mean age of their patients was 66.03±11.33 years [31]. Also Wisniewski et al., (2014) revealed that the mean age of their studied patients was 63.7±7.1 years [32]. This may be related to the incidence of COPD is growing among older age.
Concerning sex, the current study reported that more than half of studied subjects of both groups were male. These percentages are less than the percentage of Salah et al., (2013) and Akinci and Yildrin (2013) who stated that most of their sample was male [30,33]. This may be due to the lower sample size of the current study in relation to their sample size. The majority of both groups of the current study were married. This is consistent with the mean age of them.
Regarding home condition, the present study revealed that the home of majority of both groups was in good condition (sun entered the home, the houses were not crowded, good ventilated, and had sewage), so home condition is not a factor for the disease's symptoms.
National Heart, Lung and Blood Institute (2013) stated that patients with a history of smoking are more vulnerable to COPD [34]. This is in line of our study which showed that more than two thirds of studied subjects had history of smoking. They were either current or former smokers. While the current smokers represented about one third of both study and control groups for the present study. This is in line with Wisniewski et al., (2014) and Fernandz et al. (2014) [32,35].
The mean years of disease duration for subjects of the current study was 11.11±3.52 years for study group and 11.23±3.78 years for control group. This result is near the results of Akinci and Yildrin (2013) [33] who found that the mean years of disease duration for their sample was 9.1±8.5 years.
The results of the present study showed that all subjects of both groups received pervious training about inhaler use but all of them didn't follow this training. These findings are in accordance with the findings of Fadaei et al., (2016) who found that approximately all of their subjects were trained in this regard but didn't follow these training [36]. These findings were explained by Restrepo et al., (2008) who reported that retention of instructions about appropriate use of inhaler is lost over time [37].
It was stated that patient's education is one of the most important roles for a nurse in any health care setting and the nurse provides the patients with the needed information for self care to ensure continuity of care [38]. In the current study, it was noticed that the total knowledge score of study group was improved than control group post education by two weeks and one month. The result is in line with Khdour et al., (2009) and Jarab et al., (2012) who reported that the study group showed improvement of COPD knowledge when compared with control group [39,40]. Also El-Sayed et al., (2012) found a statistical improvement of total knowledge score among study group than control group post education [41].

Performance of inhaler use
Correct inhaler technique is very important, however previous studies reported that incorrect inhaler technique is common among patients with asthma or COPD [16,42]. These studies coincide with the results of our study which stated that pre education, the mean total performance of inhaler use was low for both study and control groups. While after education by two weeks and one month, there was a significant improvement in mean total performance score of inhaler use among study group than control group. These results are supported by National asthma council (2008) which stated that large body of evidence from randomized trials have shown that patient's inhaler technique can be improved by education [17]. Also Fadaei et al., (2014) revealed that using inhaler correctly requires the patients to be informed about proper use instructions [36].
Severity of dyspnea One of the most severe symptoms of chronic obstructive pulmonary disease is dyspnea and its severity increases as the disease progresses [43]. The inhaled bronchodilators are considered a corner stone for treating dyspnea but incorrect inhaler use can reduce medication effectiveness that can lead to symptoms exacerbation especially dyspnea [44,45]. This is in agreement with the results of the current study which showed that more than half of both groups had severe dyspnea pre correct inhaler's education. Improvement in dyspnea severity was observed among study group after one month than control group; however this improvement is not statistically significant. This result didn't support hypothesis number one. This may be due to the short follow up period and the improvement of dyspnea may require long follow up period however the better result observed among study group suggested that the education about correct inhaler technique is beneficial. This is supported by  who mentioned that patient's education about correct inhaler technique showed increase the effectiveness of the inhaled medication and relieving symptoms especially dyspnea [46].
The results of the current study showed that there was a statistical significance difference between mean dyspnea severity scores in relation to disease duration among study group. This may be related to the severity of the disease increase with increase duration of the disease and so manifestations such as dyspnea increase in severity.

Medication adherence
Although medical treatment of chronic obstructive pulmonary disease has advanced, non adherence to medication regimen poses a significant barrier to optimal management [37]. Non adherence to medication regimens is common among COPD patients because of chronic nature of the disease and the use of multiple medications especially they are often prescribed areolized medications to use from two to six times daily [47,48]. Haupt et al., (2008) stated that chronic obstructive pulmonary disease patients display significant low adherence to treatment [49]. Agh et al., (2011) showed that patients adhered to treatment poorly when they had several drugs prescribed [50]. This is in line with the result of the present study which illustrated that pre education, majority of both groups had low adherence to medication regimen.
It was reported that patient's knowledge of the disease process as well as the recommended treatment are critical for optimal medication adherence in patients with COPD [51]. Also several observational studies have shown that training patients on inhaler use improve not only inhalation technique but also adherence to treatment and so disease control [52,53]. This illustrates the finding of the current study that showed significant improvement in medication adherence among intervention group than control group after education about correct use of inhaler. This result supported hypotheses number two. Also this result is supported by pervious cross sectional study that revealed that instruction about inhalation technique repeatedly provided for chronic obstructive pulmonary disease patients contributes to therapeutic adherence [53].
The results of the current study revealed that mean medication adherence among both study and control groups didn't differ according to age, educational level of participants and their disease duration. This result in line with other studies carried by Wisniewski et al., (2014) and Agh et al., (2011) who reported that patient's age was not a factor that increase their adherence to treatment [32,50]. Moreover Wisniewski et al., (2014) didn't find any relation of medication adherence with education [32].

Conclusion
Based on the results of current study, it was concluded that, education about chronic obstructive pulmonary disease and correct inhaler use was effective in significantly improving total knowledge score among study group than control group. Also Poor inhalation technique is common among subjects of both groups and correct inhaler technique education appears vital to significantly improve performance of inhaler among study group than control group.
Severity of dyspnea reduced among study group than control group after correct inhaler education however the reduction of dyspnea severity was not significant. Moreover education about proper inhalation technique resulted in significant improvement of adherence to inhalation therapy among study group than control group.

Recommendations
Based on the findings of the current study, the following recommendations can be suggested: 1. Patients with chronic obstructive pulmonary disease must be regularly evaluated for their inhaler technique and reinforced to maintain correct technique because it can be deteriorated again after education.

A colored booklet about proper inhalation technique
supported by pictures for almost each step should be distributed to all COPD patients. 3. Replication of the study using a large probability sample from a broad geographical area to allow greater generalization of the results. 4. Replications of the study with long period of follow up to allow for greater understanding the effect of inhaler technique on dyspnea severity and allow for greater generalization of the results.