*4.2.1 Content and dialogue validation*

As CF is a genetic disease, patients have grown up listening to and using medical terminology to aid in the management of their condition. Therefore, the medical data that can be recorded in the app is familiar to this cohort; however, the manner in which the data is requested may be new to these patients, and subsequently may require validation. A meeting was held with CF nurse specialists to discuss the instructions on how to enter data in the app. The CF Nurse specialists were enlisted for this task due to their extensible knowledge in communicating with this cohort. There is no imagery used within the app, however, there are two proposed graphs. The graphs and app instruction were modified until validation from the nurse specialists was given.

#### *4.2.2 Data information requirements*

As the data are not being transferred and viewed by other personnel, an opt-out service and DPA policy was not required in the app. As the CF Patient Passport was developed as part of a pilot study, information pertaining to all intentions of what data was to be collected and how it was then stored was provided to patients in a participant information sheet. It was anticipated that once the app was made available via app stores and over the web, these intentions would also need to be listed.

## *4.2.3 Data and data analysis*

Focusing on the outlined scenarios (travelling between centers, traveling abroad, and bridging the gap between the healthcare team) a meeting was held with the CF MDT to discuss which data should be recorded in the app to fulfill these objectives. From this meeting it was found that the mHealth passport should follow the same architecture as a patient file. In Ireland, a patient file can include information stored once (genotype, date of birth, genotype *etc.*), information that can sometimes be recorded (such as new medical conditions or procedures), and

#### *Designing Heterogeneous-mHealth Apps for Cystic Fibrosis Adults DOI: http://dx.doi.org/10.5772/intechopen.85512*

lastly data that is recorded at every clinical appointment (lung function, weight, height *etc.*). Therefore the mHealth passport is separated into three core sections and described below. To note, all data entered into the passport can be edited or deleted if desired. These sections can be seen in **Figure 2** (right).

*Section 1 My CF Information:* This section is targeted at the information in the patient file that are only recorded once. This data generally describes a patient profile such as date of diagnosis, genotype, sweat test results, allergies, contact numbers for the healthcare team, and allergies. This can be seen in **Figure 3** (left).

*Section 2 My Medical History:* This section is dedicated to the occasional data and is divided into two sections. "My Medical Procedures" and "My Medical Conditions". The first section is targeted towards procedures a CF patients may have undergone such as the insertion of a gastrostomy tube, or the removal of a portacath. The second section focuses on new conditions or diseases which may have developed, such as diabetes.

*Section 3 My Clinic Appointments:* The final section records data that are entered into a patient file at each clinical appointment. This data can include Blood Pressure (BP), weight, height, date, lung function (FEV1% and FVC%), bugs in mucus, new treatments. This section can also be used for phone calls with the healthcare team, GP Visits, and annual assessment.

#### *4.2.4 Security operations*

However, it can also be considered as a Wellbeing/Lifestyle app as it may improve health behaviors among this cohort as they become more aware of their own

All evaluations performed with patients received ethical approval from the Clinical Research Ethics Committee in Cork. The app is currently available on the

To ensure that the app can be deployed to both Android and iOS, Cordova PhoneGap [21] was used to develop the mHealth passport. PhoneGap uses web technologies such as HTML, CSS, and JavaScript in addition to Frameworks for navigations and layouts. For this passport, Framework 7 [22] is incorporated into the app to ensure a consistent layout/style across both Android and iOS. The language and dialogue used in the app is simple so that it can be understood by nonmedical persons. All graphs are developed using the Highcharts.js framework [23]. This section will discuss the validation of content and dialogue within the applica-

tion before discussing the data that can be recorded via the passport app.

As CF is a genetic disease, patients have grown up listening to and using medical terminology to aid in the management of their condition. Therefore, the medical data that can be recorded in the app is familiar to this cohort; however, the manner in which the data is requested may be new to these patients, and subsequently may require validation. A meeting was held with CF nurse specialists to discuss the instructions on how to enter data in the app. The CF Nurse specialists were enlisted for this task due to their extensible knowledge in communicating with this cohort. There is no imagery used within the app, however, there are two proposed graphs. The graphs and app instruction were modified until validation from the nurse

As the data are not being transferred and viewed by other personnel, an opt-out service and DPA policy was not required in the app. As the CF Patient Passport was developed as part of a pilot study, information pertaining to all intentions of what data was to be collected and how it was then stored was provided to patients in a participant information sheet. It was anticipated that once the app was made available via app stores and over the web, these intentions would also

Focusing on the outlined scenarios (travelling between centers, traveling abroad, and bridging the gap between the healthcare team) a meeting was held with the CF MDT to discuss which data should be recorded in the app to fulfill these objectives. From this meeting it was found that the mHealth passport should follow the same architecture as a patient file. In Ireland, a patient file can include information stored once (genotype, date of birth, genotype *etc.*), information that can sometimes be recorded (such as new medical conditions or procedures), and

medical data/symptoms.

*4.1.3 Ethics and regulations*

*4.2.1 Content and dialogue validation*

*4.2.2 Data information requirements*

specialists was given.

need to be listed.

**114**

*4.2.3 Data and data analysis*

**4.2 Back-end**

Google Play store in Ireland and is GDPR compliant.

*Cystic Fibrosis - Heterogeneity and Personalized Treatment*

As the data is being stored on the smartphone, security precautions are put in place for local storage. First, the mHealth app is password protected (as seen in **Figure 2** left). In the event of a forgotten password, a randomly generated password is created within the app and emailed to the user. All data stored in the CF Patient Passport is optional. Any data that is recorded is encrypted using the Advanced Encryption Standard (AES) algorithm and stored in a local SQLite database. If the app is uninstalled from the device, the databases will also be deleted.

**Figure 2.** *Login screen (left) and main menu in the passport (right).*

specialists that the app will be offered to CF adolescents transferring to CF adult care and CF adults already registered in the hospital. If the patients are interested in using the app a workshop will be given by nurses on how to use the app and the data that can be recorded. The nurses will then assist the patient in entering any historical and profile data. Time is then allocated during clinical visits for patients to enter

In this section, further testing and reviews conducted on the app are discussed.

The purpose of this test was to evaluate the performance of this app and its design. Seven participants without CF were enlisted who all owned Android devices. The decision to recruit non-CF participants was intended to identify performance and design issues and to remedy them. For the stress test, participants from a similar age range to the target CF adult cohort were chosen. Five participants (three females and two males) between 19 and 51 were recruited. The technical capability of this participants varied, some participants were novices at using tech-

The participants were asked to download the mHealth passport onto their smartphones and test for 3 months. During this time participants were required to enter, edit, and delete data to "My CF Information" and "My Medical History" a minimum of once a month. However, they were requested perform the same tasks in the "My Clinic Appointments" more frequently (once a week). Each month the participants sent a report of any issues they encountered using the app (such as

At the end of this stress test it was found that there were no major performance issues and the users did not find the mHealth passport difficult to use. The primary issue reported on was a style issue that occurred on different phone screen resolutions whereby the submit button to enter data would remain behind the keyboard (users must close the keyboard before being able to submit). Another issue reported was the lack of clarity or structure when entering dates into the mHealth app. The final issue reported on was that the default "Go" button on the smartphone keyboard did not move to the next text field as expected. Following this feedback, the styling was adjusted and retested on different devices to ensure the submit button was no longer hidden, a calendar was implemented to enter in the date, and finally functionality was created and bound to the "Go" button to ensure users could navigate through the form items. The above solutions were implemented in prepa-

The CF Patient Passport was then presented to CF nurse specialists, CF physiotherapists and respiratory consultants for review. During this review, the app pur-

pose, aesthetics, dialogue, content, and functionality was reviewed. Slight modifications are recommended by the reviewers to improve the quality of data entered and prevent errors. Examples of this feedback included the incorporation of a drop-down menu which contains all possible bugs that can be growing in mucus as opposed to the patient manually entering this data. Similarly, in places where

Following on from the results of the reviews and testing, future plans for the

this data with a CF nurse or during non-contact time.

*Designing Heterogeneous-mHealth Apps for Cystic Fibrosis Adults*

*DOI: http://dx.doi.org/10.5772/intechopen.85512*

deployment of this mHealth app are outlined.

nology, while others were ICT professionals.

ration for pilot testing with CF adult patients.

*4.4.2 Peer review*

**117**

performance, usability, or general feedback) via email.

**4.4 Deployment**

*4.4.1 Stress test*

**Figure 3.**

*Menu from the "My CF Info" section (left) and list of saved clinical appointments in "My Clinic Appointments" (right).*

## **4.3 Front-end**

In keeping with the mHealth pipeline discussed previously, the User Interface (UI) and User Experience (UX) of the app are discussed.

#### *4.3.1 User interface (UI)*

A meeting was held with CF nurse specialists and physiotherapists to discuss the plausibility of an Adaptive UI. From this meeting it was determined that a UI model was not required. It was considered that perhaps an Adaptive Navigation model may be beneficial for the use cases as described in 6.5.1 under Preparation; however, this was later dismissed as data recorded and shown in the app is at the patient's discretion.

Informal discussions between the CF nurse specialists and the CF adults attending clinic found that this cohort would prefer the UI to be designed so that it does not appear to be a mHealth app. As such, the icon that was to appear on the main screen of the user's smartphone does not contain any indications that the app is for CF; hence this icon is named "My Passport". Furthermore, the style and UI elements in the app were designed so that they do not appear to be "medical" or "clinical". Similarly, all menus and buttons were created to reflect the data collected.

#### *4.3.2 User experience (UX)*

On reviewing diabetic patient passports, a number of issues which could prevent the use of such of an intervention was found. Of interest to the UX aspects of this mHealth app is outlining how the app should be implemented into the current care system. A solution for this is discussed in Section 3.2. It is agreed by CF nurse

specialists that the app will be offered to CF adolescents transferring to CF adult care and CF adults already registered in the hospital. If the patients are interested in using the app a workshop will be given by nurses on how to use the app and the data that can be recorded. The nurses will then assist the patient in entering any historical and profile data. Time is then allocated during clinical visits for patients to enter this data with a CF nurse or during non-contact time.
