Review of mHealth apps for adolescents with chronic conditions revealed a paucity of evidence-based apps, in contrast to the thousands of apps available on the app market that are not evidence-based or user or professional informed [18]. A prototype tailored mHealth asthma app was developed based on a past tailored program using touch-screen computer [19]. The social cognitive theory [20] and tailoring [10] were used to develop a new mHealth child asthma app. This is useful in children with insufficient self-management ability because their communication levels are developmentally immature. The interpersonal approach to education had a greater effect than the tailored approach [10]; however, establishing a one-on-one relationship is difficult. Therefore, this program used the tailored approach to communication as it was most similar to the interpersonal approach. Individual interviews with caregivers were used to collect information and develop tailored messages. The prototype app was developed based on tailored program issues from past research [19] that did not involve children with asthma and their caregivers in their app design.

The mHealth child asthma app comprised a combination of asthma knowledge, behavior change, target behaviors, and theory applications. There were 3 main goals for this app: to increase caregivers’ feelings of self-efficacy in their asthma management, to increase asthma knowledge, and to continue self-management behavior of controlling asthma symptoms.

The app’s protocols comprised 3 content areas: asthma knowledge, monitoring symptoms, and behavior change (Figure 1). This app was developed for infants and toddlers aged 0 to 6 years, school-going children aged 7 to 9 years and 10 to 12 years according to their developmental stages. Contents of the child asthma app for children aged 0 to 6 years and their caregivers were asthma knowledge (pictorial book about asthma clinical condition, causal factors, and complicating factors; quiz), self-monitoring of medications and symptoms, and tailored feedback according to the Japanese pediatric asthma control test [21]. Contents of this app for children aged 7 to 12 years and their caregivers were asthma knowledge (manga as a Japanese-style comic regarding asthma, medication, exercise-induced asthma, and stress management; quiz), self-monitoring of medication and symptoms, and tailored feedback according to the Japanese pediatric asthma control test.

A qualitative study was conducted, and data were analyzed using thematic analysis [22]. As part of the study, we conducted semistructured interviews, and their narratives were analyzed.

Children participants aged 0 to 12 years diagnosed with persistent asthma by allergy specialists at the National Center for Child Health and Development were recruited. The types of persistent asthma, such as severity, treatment regimen, and treatment duration, were not considered. Participants were excluded if their involvement was deemed inappropriate by the pediatrician because of their mental and physical conditions. We used purposive sampling, which gathers information-rich cases that manifest the phenomenon under investigation. Participants who matched the inclusion criteria were selected by their electronic medical record. Researchers approached caregivers of children with asthma who regularly visit the hospital through telephone. A total of 31 caregivers who met the inclusion criteria by telephone were contacted. After obtaining the temporary consent to participate in the study over the telephone, caregivers and children with asthma provided consents during the next outpatient visit.

We contacted pairs of children with asthma and caregivers. Participants received a mobile phone to demonstrate the prototype of the child asthma app and tried the app for 10 to 15 minutes in the interview room during their outpatient visit. After the prototype app trial, each participant was interviewed once for approximately 7 to 22 minutes (average 14 minutes). Interviews were conducted in an outpatient private room by one researcher, a nurse specializing in pediatric allergies from March 2019 to August 2019.

Data were gathered through semistructured interviews. An interview guide that matched the study aim was prepared. The researcher presented the interview guide and items to participants. The first author (MI), a researcher trained to carry out qualitative interviews, conducted all interviews. During each interview, the interviewer encouraged participants to talk freely about the proposed beneficial features of the app based on their experiences and provided opportunities to express features they felt had not been covered. The interviewer had no prior relationship with the participants.

Demographic information of participants, such as age, sex, age at onset of asthma, and relationship with caregivers, was collected. Interview contents were assessed using 4 viewpoints for each caregiver and children aged 7 to 12 years: (1) good aspects of the app, (2) proposed beneficial features of child asthma app, (3) notification (alert function) frequency and usage frequency, and (4) specific improvements of the app. Additional demographic information, such as age of asthma onset and treatment duration, was also collected. The app trial was conducted once for approximately 10 to 15 minutes before the interview; thereafter, these viewpoints points were mainly discussed to identify the portion of the app that needed modification and grasp the proposed beneficial features of the app. The interview guide was confirmed among 5 researchers before the study. The interview was recorded using a digital voice recorder after obtaining the assent of participants.

All recorded data were transcribed verbatim in Japanese. A thematic analysis was used to identify codes and themes (subcategories and categories) from the qualitative data [20]. Thematic analysis can be used to develop a novel theoretical framework and identify the common meanings and themes of an existing model. The qualitative data were analyzed in 4 phases: (1) becoming familiar with the collected data, (2) generating the codes and collating similar data for each code, (3) naming content-characteristic words and grouping them as categories, and (4) exploring themes agreed upon by 4 research members who engaged in consensus decision making. Each theme in this study was derived from interview data. Research members included 2 pediatric nurses (MI and MN) and 3 pediatricians specializing in allergies (YM, KY, and MN). After initial coding of each transcript, the researchers discussed and identified a set of main themes, categories, and subcategories.

The Japanese National Center for Child Health and Development committee for ethics in research of social medicine (approval number: 2028) and the university committee for ethics in research involving human subjects approved this study. Participants who met the inclusion criteria together with their caregivers were informed verbally and in writing about the aim, significance, and methods of the study. They were informed of their rights as voluntary participants, including the right to withdraw from the study, data anonymity, protection of confidential information, handling and disposal of data, and the possibility of results being published. After receiving this information, participants 7 to 12 years old provided informed written assent, and caregivers of all participants provided written consent. COREQ guidelines [23] were followed.

Out of the total 31 caregivers who were contacted by telephone, 4 caregivers of 1- to 12-year-old children (2 girls and 2 boys) did not participate because they were unable to contact us by telephone several times, and it was difficult to secure the time of the outpatient visit. A total of 27 pairs of caregivers and children were interviewed. Participant characteristics are shown in Table 1. Participants were divided into the developmental stage groups: children younger than 7 years old (n=10) and children 7 to 12 years old (n=17). The majority of caregivers were between the ages of 40 and 49 years. Two viewpoints in the prototype of the child asthma app were identified: good aspects of the app and proposed beneficial features for the app.

Four themes (confirmation of asthma knowledge, child-caregiver interaction, app design, and child’s interest) comprising the good aspects of the app were identified for children older than 7 years old with asthma and their caregivers. Moreover, 5 themes (new knowledge, manga, child’s interest, app design, self-management trigger, and app operability) comprising the good aspects of the app for 7 to 12 years old children with asthma and their caregivers were also determined. In addition, 6 themes (asthma knowledge, elements for continuous, universal design, monitoring, and functions) on the proposed beneficial features of the app were identified for children with asthma and their caregivers.

Children with asthma and their caregivers captured the features of asthma knowledge as good aspects of the app. On the one hand, they wanted elements of continuity in the app, such as quiz, manga, and games, among others. Hospital outpatients identified requiring more knowledge about the diseases through the smartphone app [24]. In addition to providing asthma knowledge, ways should be devised for 7- to 12-year-old children with asthma and even their caregivers to learn asthma knowledge while continuously accessing the app. Manga about asthma in this study was highly acclaimed by 7- to 12-year-old children with asthma. The concept of entertainment education [25], entertainment media that provide educational information intended to increase psychological readiness toward the desirable behavior change, such as television, digital games, and comics, has potentially become an effective communication strategy to implement the health message for the high-risk population [26]. Several educational programs have adapted manga as an effective learning tool, known as an educational manga [27,28]. Additionally, previous studies [29,30] challenged the application of manga or comic book for patient education targeting children. By incorporating Japanese culture manga into the app, 7- to 12- year-old children can easily accept new information that results in high educational effects. Serious games without entertainment, enjoyment, or fun as their primary purpose [31], have emerged as a new generation of videogames meant to provide education and training [32]. Although serious games designed for asthma education have evolved with advances in technology, results of their evaluation remained similar across studies, with clear improvements in knowledge but little to no change in behaviors and clinical outcomes [33]. Therefore, although game elements were useful in terms of gaining asthma knowledge, it was suggested that they were unsuitable for self-management and behavior change.

Two themes that were good aspects of this app were the child’s interest and design and operability, which were commonly reported by 7- to 12-year-old children with asthma and their caregivers. Additionally, findings on the proposed beneficial features of the app suggested that children with asthma and their caregivers wanted a universal design that could easily be used by everyone. The design and development of a self-management app included validation of app features through user-centered design methods [34,35]. The patient-centered universal design of the app should also be improved, and its feasibility determined. Furthermore, caregivers of children with asthma should also enhance the basic functions and operability, not complex functions. Children aged 7 to 12 years with asthma and their caregivers required notifications, reminders, monitoring, and alerts. This supports the findings of previous studies [36] on asthma management mHealth app for adolescents. In addition, caregivers' needs for app monitoring were to be able to share the monitoring content with their pediatrician during their outpatient visits. The sharing of symptom monitoring in children's daily lives promotes communication between children with asthma and their caregivers and pediatricians and maintains good relationships. Moreover, sharing of monitoring content helps pediatricians make treatment decisions by understanding the appearance of detailed asthma symptoms of the children. The monitoring and alerting functions should be developed not only for the ease of use but also for the pace of the user. In future app improvements, ways to set monitoring items and notifications by the users themselves should be devised. In particular, 7- to 12-year-old children with asthma wanted to keep records in monitoring while having fun. As for the monitoring function of children with asthma, incentives obtained by the child’s continuous medication intake and input symptoms are necessary.

This study had several limitations. Findings derived from 27 children and 26 caregivers at one children’s hospital were used to identify the proposed beneficial features of the app in children with asthma and their caregivers and are limited to that population. In addition, the majority of participants were boys and the majority of caregivers were mothers. Pediatric asthma has a high prevalence in boys in Japan, as is true worldwide. Furthermore, although the number of double-income families is increasing in Japan, mothers still attend the outpatient visit of children. However, in Japan, patients who go to children’s hospital are those with severe asthma and are likely to use the app frequently for long term. Therefore, the results were useful in understanding the needs of the target population: children younger than 7 years old and 7 to 12 years old with asthma and their caregivers. In addition, this study has clarified caregiver-reported proposed beneficial features of the app that in children younger than 7 years old were not as they reported. Children less than 7 years old were having difficulty for answering the questions accurately given their limited language function and cognitive development; therefore, caregivers were asked to answer their needs.

Additionally, since school-aged children aged 7 to 12 years often do not have their own mobile phones, their caregivers’ mobile phones were used. However, as shown in the results of this study, despite the child’s inconvenience in using the app, using a caregiver’s mobile phone can lead to communication and interaction between them and their caregivers. Furthermore, the study did not determine whether the app changed the participant’s behavior. Moreover, there are very few apps for child asthma management in Japan; therefore, we did not include questions in the interview on the topics of “why they would not use an app” and “what they did not like.” We also did not consider the 4 patients who declined to participate as being any different from the participants. However, considering that the app provides potentially more information is very important. Finally, it would be worth reiterating that the app was only tried for approximately 15 minutes at the time of the interview; the conditions would be very different if they were used at home. The next step should be to develop and complete the contents and features of the app including the results of this study. To continue the self-management behavior of asthma in children with asthma and their caregivers, communication and interactions between the child and caregiver should be enhanced through the app. In addition, it is necessary to consider behavior changes associated with the app usage.

One of the strengths of this study was that it included preschool children aged 0 to 6 years and school going children aged 7 to 12 years who were not previously targeted by app developers. Additionally, another strength was that it incorporated manga; therefore, children with asthma and their caregivers could have fun while learning about asthma. The app included monitoring symptoms and medication, asthma control, and tailored messages so that it could be used continuously rather than in a single sitting.

Based on the results of this study, the app was improved and completed. The completed app is now undergoing formal feasibility and usability testing in children with asthma and their caregivers. Data collection from 2 to 12 years old children, such as usage data of app features and their collection of behavior changes, will help evaluate its feasibility, usability, and operability. The process and content evaluation of the app will help identify the contents for effective patient education in preschool and school going children aged 0 to 12 years with asthma and their caregivers.

Children with asthma and their caregivers perceived the good aspects of the app about learning the asthma knowledge with fun, including manga, child–caregiver interaction, contents that interest children, and easy-to-read design such as colors. Children with asthma and their caregivers wanted not only the asthma knowledge but also the enhanced monitoring and notification functions of the app, elements that could be continuously used by children, and universal design that can easily be used for everyone.