**3.1 Considerations from similar passports**

The issues with patient passports, as listed in the Section 1.3, pertain to diabetes passports only; however, these problems are transferable. As such, they have been considered in the design of the adult cystic fibrosis passport. Firstly, by deploying the CF passport as a mobile app a number of these pitfalls may be resolved. When considering the concerns the patients expressed for security and the possibility of identity theft, an mHealth passport can be secured via a username and password. Furthermore, if the phone was lost or stolen, all passport data will be encrypted and not easily accessible. As the passport will be in a digital form on a smartphone, issues regarding the patient being over encumbered or finding it difficult to carry the passport on their person are removed. Furthermore, as the data entered into the mHealth passport is minimal, there will be no smartphone memory usage issues. Finally, as the passport will be in an mHealth form, it is unlikely that a patient will forget their smartphone and subsequently reduces the risk of forgetting the passport at clinical appointments.

## **3.2 Considerations from MDT meeting**

The remaining issues, as highlighted by members of the diabetes healthcare team, were discussed with cystic fibrosis nurse specialists at the Cork University Hospital. The below discussed solutions were work shopped and agreed upon by consensus before being implemented into the app design. Firstly, identifying the point of care the app should be introduced was considered. In the current healthcare model, the passport shall be introduced to patients who have just transferred from pediatric to the adult orientated facility. However, the app can also be introduced to existing adult patients. During this introduction, a CF nurse specialist will explain the aim of this app and why it will be of use to the patient, the data that can be entered into the passport, and when/how to use this app when meeting members of their healthcare team. The nurse will then assist the patient in entering data that can help set up their profile in the app (e.g. contact information for their healthcare team, genotype). The patient will then be made aware that all data entered into the app is voluntary and cannot be viewed outside the app. The nurse will also explain to the patient that the patient is responsible for entering data into the app.

Finally, concerns surrounding time to enter information into the passport was discussed. In Ireland, An adult CF clinic appointment can last approximately 1 hour and 15 minutes. During this clinic, patients meet each member of the MDT. The first member of this team is a CF nurse specialist who will encourage the patient to enter the data into their passport while the nurse enters the data into their patient file. Between meeting each member of the MDT there is approximately 15 minutes of free time. Therefore, if similar to the diabetic patients, the CF patients feel as though they would prefer to spend the time with the medical team member, they can enter the information during this free time instead.

Considering the benefits of a patient passport and the patient insight provided by the Patient mHealth Survey, it can be stipulated that such a tool would be beneficial to adult CF patients. Hence, this research will develop and evaluate a patient passport targeted at adults with cystic fibrosis. However, unlike the aforementioned passports, the proposed passport will be developed as a mobile application. The agenda for this app is to provide CF adults with their basic medical information and also to allow them to record their medications, along with medical data from clinical appointments. In doing this, adult CF patients may become more aware of their condition and symptoms. Additionally, three scenarios have been identified in which the proposed app may be of use to a CF adult. Firstly, it can allow a patient to receive immediate care when travelling abroad. Secondly, it will allow patients to receive care if travelling between adult CF centers. Lastly, it can be used to communicate between healthcare team members. These scenarios and the design of the passport app with reference to the General mHealth Design Pipeline will be discussed further in the following section.

It is anticipated that the app will be first offered to CF adolescents transferring to adult care. However, it can also be suggested to any CF adult. The app will be made available on both iOS app store and Google Play store, in addition to being made available on the Cork Hospital CF Centre web page. Patients will be given time during clinical appointments to enter the data with the CF nurse specialists, or they

All data collected through the app will be stored locally on the device. It shall not be transmitted or viewed by any other personnel. The data recorded will not be analyzed; however, some data shall be visualized in two interactive graphs. The first graph will display Weight over time, and the second will display lung function as FVC% and FEV1%. An example of this graph can be seen in **Figure 1**. The graph is interactive and can allow users to touch different points on the plot to view its corresponding information. The user can also save reminders for clinical appoint-

The proposed CF Patient Passport can be considered as both an In Vitro app and

a Wellbeing/Lifestyle app. The passport is intended to record a patient's basic medical information and simultaneously plot data on a graph; as such, it is considered an In Vitro app. It is not considered a Medical Device, as this data is not being used to perform a diagnostic or any immediate decision making for the patient.

can enter the data during non-contact time.

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

*Designing Heterogeneous-mHealth Apps for Cystic Fibrosis Adults*

ments or take medications through the app.

*4.1.2 Application type*

**Figure 1.**

**113**

*Lung function (FEV1, FVC) in "My Clinic Appointments".*

## **4. General mHealth design pipeline overview**

This section will discuss the design and development of the app under the headings Preparation, Back-End, Front-End, and Deployment, in accordance to the mHealth Design Pipeline described by Vagg et al. [8]. To note, a series of informal scoping meetings was held with the CF nurse specialists from the Cork adult CF unit (>10). Post initial development a further formal meeting with the entire CF multidisciplinary team was held to sign off on the CF passport app.

#### **4.1 Preparation**

Before developing or designing the CF Patient Passport, the app's purpose, app type, ethics, and regulations are defined. These considerations are discussed and outlined in the proceeding sub-sections.

#### *4.1.1 Purpose*

This section will discuss the components necessary to create a written report before developing the app. Firstly and agenda for the mHealth passport is outlined, so that the app can be implemented into the current health care model and have a positive impact on the patient. Identifying the proposed agenda of the app was discussed with members to serve the patient were identified and are listed below.

*Scenario 1 Traveling between CF centers:* In Ireland, there are five CF focused centers. Patients can transfer between these centers for varying medical or personal reasons. However, as patient data is stored as a hardcopy, there may be a delay between the patient arriving at the center and the medical professional accessing their clinical data. In this scenario, the mHealth passport can ensure that the patient can provide their basic medical data when arriving to the new unit. Such information can include recent lung function history, medications, allergies, genotypes.

*Scenario 2 Travelling abroad:* As quality of life and survival rates increase, more and more CF patients are travelling abroad. In this scenario if the patient would require any medical care when travelling abroad, the mHealth passport would ensure that the patient could provide their basic medical data (and contact information for their healthcare team) to the attending medical professional.

*Scenario 3 Bridging Gaps between the healthcare team:* In Ireland, it can be approximately 3–4 months between clinical appointments in the adult unit. Between appointments, patients may visit a General Practitioner (GP) and begin an antibiotic treatment and this data must be entered into their patient file at their next clinical appointment. The details of the new antibiotics can be either forgotten, or only partially remembered. In this scenario the app can record any interaction with any member of their health care team as well as new prescriptions or changes to care to provide a broader view of their care.

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

It is anticipated that the app will be first offered to CF adolescents transferring to adult care. However, it can also be suggested to any CF adult. The app will be made available on both iOS app store and Google Play store, in addition to being made available on the Cork Hospital CF Centre web page. Patients will be given time during clinical appointments to enter the data with the CF nurse specialists, or they can enter the data during non-contact time.

All data collected through the app will be stored locally on the device. It shall not be transmitted or viewed by any other personnel. The data recorded will not be analyzed; however, some data shall be visualized in two interactive graphs. The first graph will display Weight over time, and the second will display lung function as FVC% and FEV1%. An example of this graph can be seen in **Figure 1**. The graph is interactive and can allow users to touch different points on the plot to view its corresponding information. The user can also save reminders for clinical appointments or take medications through the app.

## *4.1.2 Application type*

data from clinical appointments. In doing this, adult CF patients may become more aware of their condition and symptoms. Additionally, three scenarios have been identified in which the proposed app may be of use to a CF adult. Firstly, it can allow a patient to receive immediate care when travelling abroad. Secondly, it will allow patients to receive care if travelling between adult CF centers. Lastly, it can be used to communicate between healthcare team members. These scenarios and the design of the passport app with reference to the General mHealth Design Pipeline

This section will discuss the design and development of the app under the headings Preparation, Back-End, Front-End, and Deployment, in accordance to the mHealth Design Pipeline described by Vagg et al. [8]. To note, a series of informal scoping meetings was held with the CF nurse specialists from the Cork adult CF unit

Before developing or designing the CF Patient Passport, the app's purpose, app type, ethics, and regulations are defined. These considerations are discussed and

This section will discuss the components necessary to create a written report before developing the app. Firstly and agenda for the mHealth passport is outlined, so that the app can be implemented into the current health care model and have a positive impact on the patient. Identifying the proposed agenda of the app was discussed with members to serve the patient were identified and are listed below. *Scenario 1 Traveling between CF centers:* In Ireland, there are five CF focused centers. Patients can transfer between these centers for varying medical or personal reasons. However, as patient data is stored as a hardcopy, there may be a delay between the patient arriving at the center and the medical professional accessing their clinical data. In this scenario, the mHealth passport can ensure that the patient can provide their basic medical data when arriving to the new unit. Such information can include recent lung function history, medications, allergies, genotypes. *Scenario 2 Travelling abroad:* As quality of life and survival rates increase, more and more CF patients are travelling abroad. In this scenario if the patient would require any medical care when travelling abroad, the mHealth passport would ensure that the patient could provide their basic medical data (and contact infor-

mation for their healthcare team) to the attending medical professional. *Scenario 3 Bridging Gaps between the healthcare team:* In Ireland, it can be approximately 3–4 months between clinical appointments in the adult unit.

Between appointments, patients may visit a General Practitioner (GP) and begin an antibiotic treatment and this data must be entered into their patient file at their next clinical appointment. The details of the new antibiotics can be either forgotten, or only partially remembered. In this scenario the app can record any interaction with any member of their health care team as well as new prescriptions or changes to

(>10). Post initial development a further formal meeting with the entire CF

multidisciplinary team was held to sign off on the CF passport app.

will be discussed further in the following section.

*Cystic Fibrosis - Heterogeneity and Personalized Treatment*

**4. General mHealth design pipeline overview**

outlined in the proceeding sub-sections.

care to provide a broader view of their care.

**4.1 Preparation**

*4.1.1 Purpose*

**112**

The proposed CF Patient Passport can be considered as both an In Vitro app and a Wellbeing/Lifestyle app. The passport is intended to record a patient's basic medical information and simultaneously plot data on a graph; as such, it is considered an In Vitro app. It is not considered a Medical Device, as this data is not being used to perform a diagnostic or any immediate decision making for the patient.

**Figure 1.** *Lung function (FEV1, FVC) in "My Clinic Appointments".*

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 medical data/symptoms.

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

*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

*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,

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.

deleted if desired. These sections can be seen in **Figure 2** (right).

*Designing Heterogeneous-mHealth Apps for Cystic Fibrosis Adults*

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

have developed, such as diabetes.

GP Visits, and annual assessment.

*4.2.4 Security operations*

**Figure 2.**

**115**

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