Video education versus face-to-face education on inhaler technique for patients with well-controlled or partly-controlled asthma: A phase IV, open-label, non-inferiority, multicenter, randomized, controlled trial
Video education versus face-to-face education on inhaler technique for patients with well- controlled or partly-controlled asthma: A phase IV, open-label, non-inferiority, multicenter, randomized, controlled trial
Hye Jung Park 1 2
Min Kwang Byun 1 2
Jae-Woo Kwon 2
Woo Kyung Kim 0 2
Dong-Ho Nahm 2
Myung-Goo Lee 2
Sang-Pyo Lee 2
Sook Young Lee 2
Ji-Hyun Lee 2
Yi Yeong Jeong 2
You Sook Cho 2
Jeong-Hee Choi 2
Byoung Whui Choi 2
0 Department of Internal Medicine, Dongguk University Ilsan Hospital , Goyang , Korea , 4 Department of Allergy & Clinical Immunology, Ajou University Hospital , Suwon, Korea, 5 Pulmonary , Allergy & Critical Care Medicine, Hallym University Chuncheon Sacred Heart Hospital , Chuncheon , Korea , 6 Department of Internal Medicine, Gachon University Gil Hospital , Incheon , Korea , 7 Department of Internal Medicine , Seoul St. Mary's Hospital, The Catholic University Medical College of Korea , Seoul , Korea , 8 Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, CHA Bundang Medical Center, CHA University , Seongnam , Korea , 9 Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Gyeongsang National University Hospital , Jinju , Korea , 10 Division of Allergy and Clinical Immunology, Department of Internal Medicine, Asan Medical Center , Seoul, Korea, 11 Pulmonary , Allergy & Critical Care Medicine, Hallym University Dongtan Sacred Heart Hospital , Hwaseong , Korea , 12 Department of Internal Medicine, Chung-Ang University Hospital , Seoul , Korea
1 Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine , Seoul , Korea , 2 Department of Internal Medicine, Kangwon National University Hospital , Chuncheon , Korea
2 Editor: Thomas Penzel, ChariteÂ - UniversitaÈtsmedizin Berlin , GERMANY
hospitals in South Korea from 30 November 2015 to 01 June 2016. Subjects were randomly
Data Availability Statement: Data underlying the
study cannot be made publicly available due to
ethical restrictions on personal data imposed by
the IRB committees of the hospitals involved in the
study. Interested researchers may contact the
Institutional Review Board of the Gangnam
Severance Hospital, Yonsei University Health
System (phone number +82-2019-4601, 4603,
4624, 4626) to request a copy of the data.
Additional Supplementary Information files are
Education on inhaler technique is critical for effective asthma treatment. However,
traditionally used face-to-face education is time-consuming, costly, and often laborious. The current
study evaluated the efficacy of a newly developed video-based inhaler technique education
A total of 184 subjects with well-controlled or partly-controlled asthma were enrolled from 12
divided into two groups in a 1:1 ratio; a control group that received face-to-face education,
and a study group that received video education. All subjects received fluticasone
propionate plus salmeterol xinafoate (Fluterol® 250/50 inhalation capsules) for 12 weeks. The
primary outcome measure was forced expiratory volume in the 1st second (FEV1) at 12
weeks. The secondary outcome measures were change in FEV1 at 4 weeks, change in
asthma control test (ACT) score, and changes in various inhaler technique parameters.
available from the Dryad Digital Repository: https://
Funding: This study was supported by research
grants from Hanmi Pharmaceutical Co., Ltd. The
funders had no role in study design, data collection
and analysis, decision to publish, or preparation of
Competing interests: The authors have declared
that no competing interests exist.
These measures were assessed with a non-inferiority margin of 10% between the control
group and the study group.
FEV1 was significantly improved at 12 weeks in the control group and the study group. After
adjustment, FEV1 improvement was not significantly inferior in the study group compared to
the control group. The secondary outcome measures, including change in FEV1 at 4 weeks,
ACT score, and various parameters pertaining to inhaler technique and satisfaction at 4 and
12 weeks did not differ significantly in the two groups. In subgroup analysis of elderly
subjects and subjects with well-controlled asthma, FEV1 was significantly improved at 12 weeks
in the study group but not the control group.
The newly developed video education technique investigated functioned as a suitable
substitute for face-to-face education on inhaler technique (dry powder inhalation capsule) in
patients with stable asthma, particularly in elderly patients and patients with well-controlled
Asthma is a chronic inflammatory airway disease, the prevalence of which is increasing
worldwide with changes of environment and genetic interaction [1±4]. Inhalers are the most
common way to deliver asthma medications. Inhaled medications include corticosteroids, which
are the most effective control drugs [5±7], and long-acting β2 agonists, which are used as
additional therapy for poorly controlled asthma. Inhaled medication is preferred over oral
medication, because inhaled medication can be delivered directly to the airways in high
concentrations while minimizing systemic bioavailability and increasing the risk±benefit ratio of
drugs. However, the prevalence of inhaler misuse including failure to properly prepare the
inhaler, failure to correctly place the inhaler, failure to breathe in and out appropriately, failure
of the patient to hold their breath after inhalation, and failure to rinse their mouth after
selfadministration reportedly ranges from 15±94% [8±14]. In addition, many patients evidently
have a false perception of their inhaler technique [
]. Inhaler misuse should be corrected,
because it leads to poorly controlled asthma [
]. The 2016 report published by the
Global Initiative for Asthma encourages clinicians to check for inaccurate inhaler use and
provide adequate education [
Various education methods of inhaler technique have been developed to improve asthma
management. Written instructions on how to use an inhaler, verbal instructions augmented
by physical demonstrations [
], pharmacist instructions on proper inhaler technique [20±
22], physician-centered education programs [
], and teach-back methods that include patient
demonstrations back to healthcare providers [
] all improve patient satisfaction, asthma
control, and prognoses. Group lectures and demonstrations, videos and multimedia
internetbased training [
], and teach-to-goal video programs have further improved the success rates
of education on inhaler technique [
]. However, all these methods are time-consuming,
costly, and labor-intensive. Some educational programs can only be implemented after
intensive training of healthcare providers. Moreover, some video-based programs require
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specialized equipment and the installation of complex software. Because there is no widely
accepted education method, many institutions use their own resources (e.g., education by a
nurse or medical resident, unofficial videos) to improve the success rates of inhaler technique
We developed a simple new educational video that can reduce the time, cost, and effort
required to educate patients on effective inhaler use. We surmised that video-based education
did not need to demonstrate superiority to face-to-face education. Non-inferiority should be
considered sufficient with regard to the usefulness of video-based education, because
videobased education could reduce the time, cost, and effort required to educate patients on the
proper use of their inhalers. We hypothesized that our newly developed education method was
not inferior to the conventional face-to face education method. The current study aimed to
evaluate the efficacy of this newly developed video-based education method (one-way
education) with regard to with inhaler technique in terms of degree of asthma control, patient
satisfaction, inhaler technique, and drug compliance in patients with well-controlled or
partlycontrolled asthma, compared to conventional face-to-face education by a healthcare provider
Materials and methods
This study was conducted in 12 hospitals in South Korea. Registration dates ranged from 30
November 2015 (date of first patient registration) to 01 June 2016 (date of last patient
registration). Follow-up periods ranged from 22 February 2016 (end of the first follow-up) to 30
August 2016 (end of the last follow-up). Subjects were enrolled if they were adults (> 19
years), had well-controlled or partly-controlled asthma (asthma control test [ACT] score 16±
25), required inhaler treatment (Fluterol1; Hanmi Pharmaceutical, Seoul, Korea) as
determined by the investigator, and had provided written informed consent to participate in the
study. Exclusion criteria were as follows: history of hypersensitivity to fluticasone propionate
or salmeterol xinafoate (the components of the drug used in the study); cardiac tachycardia;
untreated fungal or bacterial respiratory infection (including tuberculosis); moderate to severe
bronchiectasis; status asthmaticus or asthma emergency requiring intensive treatment; chronic
obstructive pulmonary disease; having received systemic steroids within 2 weeks of screening;
hypersensitivity to lactose or milk; pregnant or lactating women, women who were planning
to become pregnant, and women who were not willing to use appropriate methods of
contraception. Patients who had received previous medication (naive, oral medication, or inhaler),
except those who were currently using Fluterol1 or similar inhalation devices (e.g., Onbrez
Breezhaler1 [Novartis, Basel, Switzerland], Spiriva HandiHaler1 [Boehringer Ingelheim, Inc.,
Ingelheim am Rhein, Germany]) were eligible for inclusion in this study.
The study was designed to evaluate the efficacy and safety of video education (one-way
education) compared to face-to-face education (two-way education) for asthma control in patients
with well-controlled or partly-controlled asthma. It was a phase IV, open-label,
non-inferiority, multicenter, randomized controlled trial. Subjects who met the inclusion criteria were
randomly assigned to either the control group or the study group for 12 weeks in a 1:1 ratio, via
stratified block randomization. Group assignment was not revealed to the investigators or the
study subjects. The subjects were stratified by study center and prior experience with asthma
inhalers. Subjects visited their registered site at weeks 4 and 12 (visits #2 and #3, respectively)
to evaluate the degree of asthma control, satisfaction with inhaler use, and whether they use
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inhaler properly. In addition, all adverse events occurring during the study period were
documented, and safety was assessed via vital signs and acute exacerbation data.
Video education method
Subjects assigned to the study group watched a 10-minute video on a laptop computer when
they visited their registered site at day 1 and weeks 4 and 12 (visits #1, #2, and #3, respectively).
The video could be viewed repeatedly until the viewer could fully understand the instructions.
The video was developed by Hanmi Pharmaceutical and contained detailed information on
how to use the inhaler device. The video was comprised of three parts: (1) An explanation of
the device's structure by an unseen narrator, accompanied by an on-screen picture of the
device; (2) device demonstration by an expert; and (3) a summary of how to use the device by
an unseen narrator [https://doi.org/10.5061/dryad.7vn81m1], while showing a picture
indicating the direction of the device [S1 File]. In addition, manuals on how to use inhaler
medications were provided to the subjects to reinforce the knowledge acquired during the video
session. The total duration of each video session was 10 minutes.
Face-to-face education method
The face-to-face education (two-way education) method was set up by the investigators who
were responsible for education on inhaler technique. The optimal education strategy for
correct inhaler technique was adjusted to each subject's needs, and inhalation errors were
minimized via patient demonstration of the inhaler technique and error correction by the
investigator. This process was comprised of five parts: 1) Face-to-face, step-by-step explanation of the
inhaler use manual by the investigator (S1 File); 2) confirmation by the investigator that the
subjects used the inhaler properly; 3) error correction and re-education according to each
subject's needs; 4) reassessment and confirmation by the investigator that the subjects used the
inhaler properly; and 5) provision of a manual to the subjects to reinforce the knowledge
acquired during the face-to-face education session.
Data collection and definitions
We collected detailed data pertaining to comorbidity, including various vascular, pulmonary,
neurologic, endocrine, myocardial, renal, liver, and gastrointestinal diseases. We used
Charlson's comorbidity to classify comorbidity condition. Charlson's comorbidity index was
calculated in accordance with the literature [
]. Predicted lung function (%) was calculated as
previously described by Quanjer et al. [
]. This equation can be applied globally in different
ethnic groups in subjects aged 3±95 years.
The drug used in the inhaler system utilized by all patients in the study (Fluterol1) contains a
combination of 250 μg fluticasone propionate and 50 μg salmeterol xinafoate per capsule.
Fluterol1 was approved for maintenance treatment in asthma and chronic obstructive pulmonary
disease by the Ministry of Food and Drug Safety of Korea on 22 January 2014. Capsules
containing fluticasone/salmeterol are inserted into a small device, and to inhale the medication
users must press the button and breathe through the mouthpiece rapidly.
The primary endpoint of this study was forced expiratory volume in the 1st second (FEV1) as
determined via spirometry at 12 weeks. In stable asthma with short-term treatment, changes
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in FEV1 are more sensitive than changes in exacerbation rate and ACT score [
was performed in accordance with the American Thoracic Society recommendations [
] by a
specially trained nurse, The secondary outcomes assessed in each group were FEV1 change at
4 weeks compared to baseline, change in ACT score, change in inhaler technique score,
number of critical errors, percentage of optimal inhaler technique subjects, feeling of satisfaction
with inhaler (FSI-10) [
], and adherence rate (%) at 4 and 12 weeks compared to baseline (S2
File). These outcomes were observed and assessed by the investigator.
Data obtained from the study subjects were analyzed using the full analysis set (FAS),
per-protocol set (PPS), and safety set. To assess group differences in baseline characteristics, the t-test
or Wilcoxon rank-sum test were used for continuous variables, and Pearson's chi-square test
or Fisher's exact test were used for categorical variables. To evaluate the non-inferiority of the
difference between the two groups (study group vs. control group), analysis of covariance
(ANCOVA) incorporating FEV1 at baseline, prior experience with an inhaler for asthma, and
sex was performed. If the lower limit of the two-sided 95% confidence interval of the
leastsquare means difference between the two groups was greater than -10%, the study group was
considered non-inferior compared to the control group. Post-hoc subgroup analysis was
performed to assess associations between primary outcomes and age and ACT score. Power
calculation analysis showed that with a change in the FEV1 standard deviation of 18.03% and a
noninferiority margin of 10%, a power of 90% and alpha of 0.025 would require 69 subjects per
group. The confidence interval used in safety assessment was calculated based on the code
developed by John C. Pezzulla (http://www.sample-size.net/confidence-interval-proportion/).
All statistical tests were performed with a two-sided significance level of 0.05.
This study was approved by the Ethics Committee of the National Evidence-Based Healthcare
Collaborating Agency. The protocol was also approved by the institutional review board of
each participating center (approval dates varied, but all were between 23 November 2015 and
01 February 2016) (S3±S5 Files). All patients provided written informed consent to
participation in the study. The authors confirm that all previous and ongoing trials related to this drug/
intervention are registered. This current trial is registered in the ClinicalTrial.gov registry
(number NCT03110874). Although registration in the ClinicalTrial.gov registry was delayed,
the study complied with the CONSORT checklist.
A total of 185 subjects were screened for eligibility. One patient who had an ACT score of 10
was excluded based on the inclusion criteria. The remaining 184 were randomized into a
control group (face-to-face education/two-way education; n = 92) and an study group (video
education/one-way education; n = 92). A total of 7 patients were lost to follow-up (never returned
to their respective clinics after their initial visit). Thus, 177 subjects were included in the safety
analysis (the safety set; control group n = 88, study group n = 89). Two early drop-outs were
subsequently excluded, leaving a FAS of 175 subjects (control group n = 87, study group
n = 88). Of these, 44 were excluded. Ultimately, the per-protocol set (PPS) analyzed included
131 subjects (control group n = 65, study group n = 66) (Fig 1).
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Fig 1. Study flow.
In the control group the mean age ± standard deviation was 52.0 ± 15.3 years, and in the study
group it was 52.5 ± 16.7 years (p = 0.62). There were significantly more male subjects in the
study group (55.2%) than in the control group (37.5%) (p = 0.02). There were no significant
differences in the distributions of height, weight, prevalence of current smokers, education
level, family history of asthma, family history of allergy, or duration of asthma between the two
groups. The respective proportions of subjects with prior experience using an asthma inhaler
were 88.6% and 90.8% in the control and study groups (p = 0.64). Charlson's comorbidity
index did not differ significantly in the two groups (p = 0.55) (Table 1).
FEV1 improvement after 12 weeks in the control and study groups
In the FAS analysis, FEV1 was significantly improved in the control group (from 85.3 ± 1.7%
[mean ± standard error of the mean] to 89.4 ± 1.6%; p < 0.01) and the study group (from
84.8 ± 1.6% to 88.1 ± 14.2%; p < 0.01). The difference in FEV1 improvement between the two
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(n = 87)
52.5 ± 16.7
163.4 ± 9.6
65.2 ± 11.2
5.7 ± 6.2
0.09 ± 0.38
groups was not significant after adjustment for FEV1 at baseline, prior experience using an
asthma inhaler, and sex (p = 0.60) (Fig 2A). In PPS analysis, there was also a significant
improvement in FEV1 in both groups, but no significant difference in the improvement
between the two groups (p = 0.70) (Fig 2B).
Fig 2. FEV1 improvement after 12 weeks in FAS (A) and PPS analysis (B). The t-test or Wilcoxon's signed rank test were used to analyze improvement within
groups, and ANCOVA was used for comparisons of improvement between the two groups. The data are presented as the mean (dot) and standard error of the
mean (bar). FEV1, forced expiratory volume in the 1st second; FAS, full analysis set; PPS, per-protocol set.
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FEV1 improvements after 4 weeks in the control and study groups
In FAS analysis, FEV1 was significantly improved in the control group (from 85.3 ± 1.7% to
88.7 ± 1.6%; p < 0.01) and the study group (from 84.8 ± 1.6% to 89.2 ± 1.5%; p < 0.01). There
was no significant difference between the FEV1 improvements in the two groups after
adjustment for confounding variables (p = 0.24) (Fig 3A). PPS analysis showed the same trends as
FAS analysis (Fig 3B).
ACT improvements after 4 and 12 weeks in the control and study groups
In FAS analysis, in the control group there were significant improvements in ACT from
baseline (19.6 ± 0.3; mean ± standard error of the mean) at 4 weeks (21.3 ± 0.3, p < 0.01) and 12
weeks (22.3 ± 0.3, p < 0.01). In the study group there were also significant improvements in
ACT from baseline (19.9 ± 0.3) at 4 weeks (21.9 ± 0.3, p < 0.01) and 12 weeks (22.2 ± 0.3,
p < 0.01) (Fig 3C). The results of PPS analysis were similar to those of FAS analysis (Fig 3D).
Inhaler technique at 4 and 12 weeks in the control and study groups
In FAS analysis, in the control group there were significant improvements in inhaler technique
score from baseline (7.4 ± 0.1; mean ± standard error of the mean) at 4 weeks (7.7 ± 0.1,
p < 0.01) and 12 weeks (7.8 ± 0.1, p < 0.01). In the study group, there were also significant
improvements in inhaler technique from baseline (7.1 ± 0.1) at 4 weeks (7.7 ± 0.1, p < 0.01)
and 12 weeks (7.8 ± 0.1, p < 0.01). There were no significant differences in inhaler technique
improvements between the two groups at 4 weeks (p = 0.86) or 12 weeks (p = 0.86) after
adjustment for confounding variables (Fig 3E). PPS analysis yielded similar results (Fig 3F).
Other secondary outcomes at 4 and 12 weeks in the control and study
In FAS and PPS analysis, the control and study groups did not differ significantly from each
other with regard to the number of critical errors, the number of subjects with optimal inhaler
technique, FSI-10, or adherence rates at 4 weeks or 12 weeks (Table 2).
Post-hoc subgroup analysis for the primary outcome according to age and
baseline ACT score
In subjects aged < 60 years and subjects with partly-controlled asthma (ACT score 16±19),
FEV1 was significantly improved at 12 weeks in the control group and in the study group,
and there was no significant difference between the two groups. However, in elderly subjects
(aged 60 years) and subjects with well-controlled asthma (ACT score 20±25), FEV1 was
significantly improved at 12 weeks in the study group but not in the control group. However,
there was no significant difference between the two groups (Table 3).
The teaching methods investigated in the current study did not directly induce adverse events.
However, some adverse events that were unrelated to the teaching methods did occur. The
incidence of adverse events reported in the safety set was 32.6% (95% CI 25.6±39.8%) in the
control group, and it was 30.7% (95% CI 24.1±38.0%) in the study group. The most common
adverse events were respiratory symptoms including upper respiratory infection, rhinorrhea,
and cough (14.8% [95% CI 8.0±23.7%] and 18.0% [95% CI 12.6±30.4%] in the study group
and the control group, respectively), followed by gastroenterology discomfort and muscle
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Fig 3. FEV1 improvement in the FAS (A) and PPS (B), ACT improvement in the FAS (C) and PPS (D), and inhaler technique score
improvement in the FAS (E) and PPS (F). The t-test or Wilcoxon's signed rank test were used to analyze improvement within groups,
and ANCOVA was used for comparisons of improvement between the two groups. The data are presented as the mean (dot) and
standard error of the mean (bar). FEV1, forced expiratory volume in the 1st second; ACT, asthma control test; FAS, full analysis set; PPS,
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Number of subjects with optimal inhaler technique
FAS, full analysis set; PPS, per protocol set; FSI-10, feeling of satisfaction with inhaler
P-value between two groups was obtained by ANCOVA analysis adjusted with FEV1 at baseline, prior experience of inhaler for asthma, and sex;
Data are presented as mean ± standard deviation or number (%)
ACT, asthma control test; FAS, full analysis set; PPS, per protocol set
, P-value for improvement obtained by paired t-test;
², P-value between two groups obtained by ANCOVA analysis adjusted with FEV1 at baseline, prior experience of inhaler for asthma, and sex
Insignificant P-value for improvement was presented as bold
Data are presented as mean ± standard deviation
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pain. The incidence of drug-specific adverse reactions was 4.5% (95% CI 1.2±11.1%) in the
control group, and in the study group it was 5.7% (95% CI 1.9±12.8%). The incidence of
serious adverse events in the control group was 1.1% (95% CI 0.0±6.2%; 1 case, road traffic
accident), and in the study group it was 3.4% (95% CI 0.7±9.5%; 3 cases, neck/shoulder pain, germ
cell cancer, and leg pain). There were no statistically significant differences in the rates of
adverse events between the two groups (p > 0.05).
We developed a video education method that is cheap and can be easily installed on various
types of hardware. The video education method was not inferior to conventional face-to-face
education, which is time-consuming, costly, and labor-intensive. In order to achieve the
desired therapeutic effects of an inhaler, the correct dose should be inhaled directly into the
airway through the correct use of the inhaler. Incorrect inhaler use leads to insufficient drug
efficacy, patient dissatisfaction, and poor asthma control and prognosis [
Therefore, proper inhaler education is crucial to achieving the desired therapeutic effects. Notably
however, adequate inhalation education is not fully practiced due to a lack of medical staff,
associated financial costs, and a lack of sufficient equipment. Educational videos provided by
inhaler manufacturers are used unofficially in many institutions. However, quantitative
comparative studies investigating inhaler education using video education or other methods are
rare. In the present study, we showed that educational videos could replace face-to-face
education on inhaler technique, particularly in elderly subjects and in subjects with well-controlled
asthma. Clinicians could use this new method to educate their patients on correct inhaler use.
This study showed that both face-to-face education and video education promote correct
inhaler use and yield similar clinical outcomes. Although many studies have reported sufficient
inhaler technique success rates, studies involving comparisons of clinical outcomes between
methods are rare. The endpoints in the current study included lung function (FEV1) and
symptoms (ACT), which are the most important measures of asthma management.
Improvements in these measures met minimal clinically important difference criteria [
]. In addition
to correct inhaler technique performance, inhaler satisfaction and compliance associated with
the video education method were not inferior to those associated with face-to-face education.
In addition, video education appeared to be equally as safe and effective for providing training
in the techniques required to use a new device as face-to-face education.
Interestingly, in the current study elderly subjects and subjects with well-controlled asthma
benefited more from educational videos. Elderly people tend to exhibit poor device technique,
and it has been suggested that poor cognition and impaired vision may be two of the
underlying reasons for this [
]. Therefore, many clinicians have investigated methods to
achieve proper device technique in elderly patients [
]. We found that video education was a
good method for demonstrating correct inhaler technique to elderly people. This result may
have been due to the slow and clear explanatory nature of the content of the educational video.
In addition, patients with well-controlled asthma may be relatively poorly motivated with
regard to engaging in face-to-face education. Older adults can replay the video as many times
as needed, without feeling self-conscious or guilty about asking their healthcare provider for
further explanation. Such phenomena may be particularly relevant in low-resource clinics like
Korea where the doctor does not receive additional remuneration for the time spent providing
inhaler education. Thus, an educational video could prove superior. Therefore, we recommend
the use of educational videos in the elderly and in patients with well-controlled asthma.
We tried to minimize bias during the analysis, and to make the results robust. First, we
adjusted critical parameters to obtain reliable results. Sex distribution differed significantly in
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the two groups, therefore we adjusted the analysis for sex. Although prior experience with an
asthma inhaler did not differ significantly in the two groups, this factor was also adjusted for
because it has been suggested that prior experience with a different inhaler device may
negatively affect the results of inhaler technique education pertaining to a new device [
without experience will find learning the inhaler technique more difficult than subjects with
experience. In addition, baseline FEV1 was adjusted to match baseline lung function. We
adjusted the analysis for three factors using ANCOVA. Second, we conducted both FAS and
PPS analysis, and the results of each were similar. Third, various parameters pertaining to
inhaler technique including the number of critical errors, the number of subjects with optimal
inhaler technique, FSI-10, and adherence rates were analyzed, and the results of these analyses
showed the same trends.
The results of the current study are applicable to patients with well-controlled asthma and
partly-controlled asthma. Patients with uncontrolled asthma should be carefully educated and
managed. From the outset, we considered that patients with uncontrolled asthma would need
more intensive education and management than that provided by a simple video education
program. For this reason, we decided to only enroll patients with well-controlled or
Video education can be applied easily in most institutes. It does not require high-quality
equipment, complex software, substantial space, or significant financial outlay. It is very cheap
and simple. Clinicians can deliver this educational program via various types of hardware
(including computers, tablets, and even mobile phones), and begin using the video
immediately to educate their patients. Patients can watch such a video independently in 10 min. No
help from clinicians, nurses, or paramedics is required. After watching the video, patients do
not require any further help or processing.
This study had some limitations. First, it included many patients with stable asthma
without recent exacerbation who had previous experience with inhaler use. These patients may
not have been ideal candidates with regard to demonstrating significant improvements in
symptoms and lung function. The small improvements in FEV1 and ACT scores in the two
groups in the study may reflect this. However, if education on inhaler technique was not
sufficient, clinical outcomes may have been worse than baseline. Therefore, we did not consider
these to be confounding factors. Second, face-to-face education varies in different
institutions and with different healthcare providers. However, we tried to reduce this variation by
issuing formal instructions to all participating healthcare providers aimed at promoting
standardization (at least to the extent that was possible) in this regard. Third, the asthma
management regimes and the corresponding educational video investigated in this study only
pertained to the use of one type of inhaler, Fluterol1. The effectiveness of the educational
video method should be verified with various types of inhalers. Fourth, this study was not
blinded and the role of the investigators in the intervention may have influenced the results
because it was a multicenter intervention trial. Fifth, we excluded many women of
reproductive age due to uncertainty of the safety of the use of inhalers containing long-acting
bronchodilators in such patients; and this may have skewed the results. Lastly, additional
longterm studies including many patients with severe asthma should be conducted, to confirm
the results of the present study.
The above-described newly developed educational video tool may constitute a suitable
substitute for face-to-face education on inhaler technique in stable asthma patients. Beyond this, in
elderly asthmatics and patients with well-controlled asthma video education may be even be
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more beneficial than face-to-face education. This new method has the potential to enhance
patient education on inhaler technique in various contexts, and improve asthma management.
S1 File. Handout with usage instruction.
S2 File. Definitions of study endpoints.
S3 File. Study protocol in Korean.
S4 File. Study protocol in English.
S5 File. CONSORT 2010 checklist.
The authors thank Ms. Yukyung Chang from the Statistics Team of C&R Research Inc. for
performing the statistical analyses.
Conceptualization: Hye Jung Park, Sook Young Lee, Byoung Whui Choi.
Data curation: Min Kwang Byun, Jae-Woo Kwon, Woo Kyung Kim, Dong-Ho Nahm,
Myung-Goo Lee, Sang-Pyo Lee, Ji-Hyun Lee, Yi Yeong Jeong, You Sook Cho, Jeong-Hee
Choi, Byoung Whui Choi.
Formal analysis: Hye Jung Park, Min Kwang Byun.
Funding acquisition: Min Kwang Byun, Byoung Whui Choi.
Investigation: Woo Kyung Kim, Dong-Ho Nahm, Ji-Hyun Lee, Yi Yeong Jeong, You Sook
Cho, Jeong-Hee Choi.
Methodology: Min Kwang Byun, Jae-Woo Kwon, Myung-Goo Lee, Sang-Pyo Lee, Sook
Young Lee, Byoung Whui Choi.
Project administration: Min Kwang Byun, Byoung Whui Choi.
Resources: Min Kwang Byun, Jae-Woo Kwon, Woo Kyung Kim, Dong-Ho Nahm,
MyungGoo Lee, Sang-Pyo Lee, Sook Young Lee, Ji-Hyun Lee, Yi Yeong Jeong, You Sook Cho,
Jeong-Hee Choi, Byoung Whui Choi.
Software: Woo Kyung Kim, Dong-Ho Nahm, Sang-Pyo Lee, Ji-Hyun Lee, You Sook Cho,
Supervision: Min Kwang Byun, Jae-Woo Kwon, Sang-Pyo Lee, Sook Young Lee, Ji-Hyun Lee,
You Sook Cho.
Validation: Dong-Ho Nahm, Myung-Goo Lee, Yi Yeong Jeong, Jeong-Hee Choi, Byoung
Visualization: Hye Jung Park, Min Kwang Byun.
13 / 15
Writing ± original draft: Hye Jung Park, Min Kwang Byun.
Writing ± review & editing: Hye Jung Park, Min Kwang Byun.
14 / 15
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