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Introduction to the Project

The problem of sickle cell disease (SCD) has been developing at an exponentially high rate, causing multiple fatal outcomes in patients, as well as making them vulnerable to numerous infectious diseases (Badawy et al., 2017). The issue must be addressed as a global concern that affects vulnerable and disadvantaged groups in remote areas. Applying hydroxyurea-based therapy (HU therapy) combined with the use of a pill packaging system and a mobile application to instances of SCD provides one approach to treating the disease and preventing the further spread of SCD, at the same time catering to the needs of people that have been affected by SCD.

In this context, a pill packaging system is associated with the use of pill boxes, blisters, packs of blisters, unit-dose systems, or blended systems to organize taking a required dose of medications regularly (Conn et al., 2015; Lorenzini & Hellström, 2017). The application of these systems during HU therapy is viewed as a beneficial intervention for patients with SCD.

To understand the gravity of the problem, it is important to consider the nature of the malady. The development of SCD is linked to decreased levels of hemoglobin in red cells. Thus, SCD is a group of inherited red blood cell disorders when red blood cells become hard and sticky and & die early, which causes a constant shortage of red blood cells (Centers for Disease Control and Prevention, 2017, para. 1). When red blood cells move through small and narrow blood vessels, they become stuck and prevent a normal blood flow, causing pain as well as other health problems (Adams-Graves & Bronte-Jordan, 2016).

Therefore, it is important to ensure that SCD patients adhere to their medication to relieve their state. The project is aimed at analyzing the outcomes that the combination of applying HU along with a pill packaging system and a mobile application has on medication adherence in SCD patients.

Numerous approaches toward managing SCD exist, and HU therapy is among them. HU is defined as an antimetabolite drug that increases the amount of important fetal hemoglobin (Hb F) in individuals red blood cells. Furthermore, HU inhibits ribonucleoside diphosphate reductase, preventing changes in the red blood cells (Hosseini et al., 2016; Keikhaei, Yousefi, & Bahadoram, 2016).

As a result of HU effects, the red blood cells do not change their shape and form and remain flexible not to affect the blood flow in vessels (Keikhaei et al., 2016). This effect leads to preventing the development of the pain syndrome in patients with SCD, but to observe positive outcomes, it is necessary to take HU for several weeks (Araujo et al., 2016; Wilson & Nelson, 2015). Therefore, patients adherence to this medication is of critical importance to prevent or relieve pain and improve their quality of life (Badawy et al., 2017).

When designing a treatment method based on the use of HU, it is vital to keep in mind that adhering to HU is a complex therapy that requires proper patient perceptions (Badawy et al., 2017). Since HU therapy implies direct collaboration between medical professionals and the patient and active education of the patient, designing a communication channel that will enable a nurse to administer HU-based treatment is essential.

HU-based therapy will assist patients with SCD in managing a pain crisis because of preventing clots in blood vessels that cause pain (McGann et al., 2016). Patient outcomes can also be improved by the utilization of a pill packaging system that implies the arrangement of the necessary pills in boxes for each intake for patients convenience (Conn et al., 2015). It is noteworthy that the effectiveness of HU-based therapy supported by the employment of a pill packaging system when treating SCD has not received much attention among researchers.

Chapter One includes a synopsis of the background of this project and the problem statement. The purpose of the current project and the clinical question will be further provided in this chapter. Chapter One also overviews the potential advancement of scientific knowledge this project can offer, the projects significance, and the rationale for the chosen methodology. This chapter describes the project design and methodology and provides the definitions of the employed terms and concepts. Chapter One outlines the projects assumptions, limitations, and delimitations.

Background of the Project

The problem of SCD has been studied in depth, yet no treatment that can remove all symptoms and cure patients completely has been found to date. In the United States, at least 100,000 people currently suffer from SCD (Centers for Disease Control and Prevention, 2017). While on a global scale, the problem might not seem drastic, in some areas, including most of the African continent, the rates of SCD reach as high as 30% of the population (Badawy et al., 2017; Kutlar et al., 2019). Studies show that the cause of SCD lies in the genetic mutation of hemoglobin (Badawy et al., 2017; Kutlar et al., 2019). Addressing the problem of SCD and curing the disease completely would necessitate performing a meticulous genome study, which is currently impossible (Badawy et al., 2017).

In the present and past, SCD is primarily treated with hydroxyurea as the main approved drug to address this state. To support the HU-based therapy, supportive care measures were proposed to patients (Adams-Graves & Bronte-Jordan, 2016). Furthermore, for the past two decades, patients with SCD received such options as chronic blood transfusions as well as the stem cell transplantation that are rather costly in comparison to taking HU (Badawy et al., 2017).

Therefore currently, it is important to focus on how to improve HU therapy in order to increase the degree of pain control for patients (McGann et al., 2016). The use of pill packaging systems and mobile applications as reminders is viewed as important to contribute to adherence to hydroxyurea in patients (Huang, 2000; McGann et al., 2016; Telen, 2016). The reason is that those patients, who take hydroxyurea regularly, suffer from pain crises rarely (Badawy et al., 2017; Hosseini et al., 2016; Huang, 2000).

Problem Statement

It is not known whether a combination of HU facilitated by the use of a pill packaging system as an approach to organizing patients medications and the use of a mobile application can have a positive impact on the adherence to hydroxyurea for patients with SCD. Although SCD might seem a minor concern on a global scale, especially when compared to other disorders and diseases, its scope is significant for the United States because SCD is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017). Developing an intervention for managing SCD is a necessary step in meeting the needs of SCD patients.

Although numerous strategies have been designed to address SCD, little progress has been made so far in terms of SCD prevention and control. Furthermore, the use of such pill packaging systems as pill organizers to simplify the process of taking drugs and increase adherence to minimize pain episodes also needs examination in the context of HU therapy (Badawy et al., 2017; Conn et al., 2015).

HU is one of a few therapies that have delivered promising outcomes to date, suggesting that its effects on SCD patients and populations vulnerable to SCD should be explored in depth. It is believed that the application of HU will allow for alleviating the painful experiences typical of SCD patients (Badawy et al., 2017). A lack of information on the positive and negative aspects of using HU presents an additional obstacle to managing the problem and makes the further study of HU an urgent measure (Lê et al., 2015). The use of pill packaging systems needs detailed investigation since only some aspects of pill intake management were previously examined by researchers including Huang (2000) and Kopelowicz et al. (2015).

The need for this project is in the fact that is necessary to determine the potential of taking hydroxyurea in combination with using pill packaging systems and a mobile application for reminders for increasing medication adherence and addressing pain crises. Sufficient studies have not been conducted regarding the effects of taking HU with the help of pill packaging systems or mobile applications on patients medication adherence and possible pain experiences (Badawy et al., 2017; McGann et al., 2016). It is essential to evaluate the combination of the HU-based therapy and a pill packaging system, as well as using a mobile application in order to identify the relationship between this approach and medication adherence affecting the quality of patients life.

This project will contribute to solving the problem of patients pain episodes providing information on opportunities for improving the well-being of people with SCD with the help of affecting their adherence to HU. The limited amount of evidence supporting the positive effects of HU combined with the use of a pill packaging system and facilitated by using a mobile app signifies the need for immediate research. A recent article has indicated that the application of HU deserves scrutiny as a potential strategy to ameliorate the conditions of current SCD patients (Badawy et al., 2017).

Purpose of the Project

The purpose of this quantitative descriptive project was to determine to what degree HU therapy combined with using a pill packaging system and a mobile application could affect possible changes in the adherence of SCD patients to their medication. The use of a pill packaging system and a mobile application as an independent variable will be measured with reference to the application or not of this intervention by patients with SCD.

The medication adherence as a dependent variable will be measured with reference to the regularity of taking HU. The discussion of positive and negative outcomes of the proposed therapy combined with the pill packaging intervention contributes to creating strategies that may help to address pain episodes associated with the disease in question. The project explores the opportunities for the management of SCD in patients, especially African Americans (Lê et al., 2015). The examination of interventions, such as the combination of HU therapy with pill packaging systems and a mobile application oriented toward improving the adherence to HU is important to determine the effectiveness of these interventions to decrease such effects of SCD as pain crises.

The problem of low quality of life and the physical discomfort afflicting SCD patients and associated with pain must be managed as an evident concern. The application of an approach based on HU may lead to vast improvements among people with SCD when coupled with using convenient pill packaging systems and a mobile application (Badawy et al., 2017). The opportunities that HU combined with a pill packaging system provides must be examined to enhance the current quality of nursing care and ensure that the level of awareness rises among SCD patients, their parents, at-risk groups, and general audiences.

To address the problem, it is necessary to explore the nature of SCD and the effects that HU therapy facilitated by a pill packaging system and a mobile app produces on patients. The current approach to the effort to cure SCD associated with blood transfusions and transplantations allows for helping only a small group of patients due to the high costs of procedures (Wilson & Nelson, 2015). An analysis of the advantages and disadvantages of the HU-based pill packaging system contributes to solving and problem and provides an opportunity to design a framework for managing the need of any SCD patient or a group of patients.

Clinical Question

The project in question strives to determine whether HU therapy enhanced by a pill packaging system and a mobile application can be associated with the higher levels of medication adherence to prevent pain episodes in patients with SCD. Therefore, this project determined how the specified strategy contributes to increasing medication adherence among patients and enables nurses to increase their competency levels. The opportunity for using pill packaging systems and a mobile application can also serve as a method of sustaining the high quality of life in SCD patients because of addressing pain.

The following clinical question guides this quantitative project:

Q1: In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?

In this question, HU therapy based on using pill packaging systems and a mobile app as an independent variable is defined by following the intervention by SCD patients. Thus, possible changes in medication adherence in patients with SCD are the dependent variable, and the data on it were collected with the help of a questionnaire. It is important to determine whether the intervention, such as the use of HU therapy with pill packaging systems and a mobile application can promote medication adherence in patients with SCD.

Advancing Scientific Knowledge

It is critical to encourage the advancement of scientific knowledge associated with the management of SCD to address and prevent pain episodes or crises that are observed when HU is taken irregularly and medication adherence is low.

When considering the rationale for the project, it is important to mention the lack of studies that handle the topic of HU in combination with pill packaging and other systems to increase medication adherence as a possible solution to SCD-related pain. Currently, a significant gap exists in the scientific knowledge of HU as a tool for improving the quality of SCD patients lives by increasing their adherence to HU and relieving their pain, as well as promoting patient education concerning the use of mobile applications as reminders (Kopelowicz et al., 2015; Lê et al., 2015).

The findings of the studies that are currently available provide reasons to believe that the application of HU therapy can facilitate patient control, which will lead to a drop in the levels of pain common in SCD patients (Centers for Disease Control and Prevention, 2017). The focus must be on the need to study the opportunities that HU and pill packaging systems, as well as mobile app reminders, provide for SCD patients.

The application of the proposed strategy based on HU, pill packaging systems, and a mobile app is likely to lead to a change in medication adherence and pain cycles observed in SCD patients (Badawy, Thompson, & Liem, 2016; Badawy et al., 2017). According to Wilson and Nelson (2015), HU therapy provides a relatively cheap and possibly effective alternative to existing approaches, most of which are quite costly.

Stettler, McKiernan, Adejoro, and Walczak (2015) made the following specific claim: Despite evidence demonstrating the benefits of hydroxyurea in patients with SCD and frequent pain crises, this analysis suggests that more than 3 of 4 patients who might benefit were not treated with this safe and inexpensive drug (p. 1671). The current barriers to treatment include the refusal to acknowledge that HU therapy delivers impressive results and that significant outcomes can be achieved through high-level medication adherence (Badawy et al., 2017).

The few studies that explore the link between HU and the quality of SCD patients lives prove that HU can potentially benefit people suffering from SCD. The opportunities under consideration occur due to the presence of elements that help to address the vasoocclusive crisis (VOC) in HU (Centers for Disease Control and Prevention, 2017). A few studies that do serve to tackle the problem of pain management in patients having SCD with the help of HU and delve into the mechanics of the process have proven HUs efficacy (Badawy et al., 2017).

These studies have provided reasons to believe that the adherence to HU can help to reduce the pain experienced by patients with SCD. HU can counteract the activation of platelets in SCD patients that typically leads to inflammation and further aggravation of the SCD condition (Kutlar et al., 2019). The use of HU, in turn, will help to reduce inflammation and alleviate negative experiences (Lorenzini & Hellström, 2017; Zhang, Xu, Manwani, & Frenett, 2016). The described intervention with a focus on combining HU therapy with a pill packaging system and a mobile app can allow for improving medication adherence and addressing pain (Badawy et al., 2017).

Although the impact of the provision of HU therapy facilitated by a pill packaging system is unknown, recent research on the effects of pill packaging systems in treating similar conditions suggests improved patient outcomes (Lorenzini & Hellström, 2017). The use of a pill packaging system and mobile reminders in apps in HU-based therapy is expected to improve the quality of patients lives through increasing the adherence to HU.

The theory of planned behavior is a theoretical model that supports the project and tends to explain how the usage of pill packaging systems can lead to changes in medication adherence in patients. This theory was developed by Icek Ajzen, who determined particular factors affecting changes in peoples individual behaviors. Ajzen (1985) claimed that peoples attitudes, behavioral control, and subjective norms should be viewed as predictors of an individuals decision to choose a behavior.

The process of decision making and selecting a behavior (in this project, the behavior is adherence or not to medications) is based on a persons evaluation influenced by the mentioned predictors. The project adds to explaining how this theoretical model can be applied to the topic of taking medications regularly to improve health outcomes and advances the approach to modeling patients behavior with the help of proposing some instruments, like pill packaging or a mobile app (Rich, Brandes, Mullan, & Hagger, 2015).

Significance of the Project

The project has practical significance for improving medication adherence in patients with SCD who need to take hydroxyurea regularly, following their specific regimen, in order to guarantee the prevention of pain episodes. This project provides new insights into the realization of HU therapy with reference to using pill packaging systems and a mobile application (Mango Health) in order to ensure patients do not forget to take pills regularly. Therefore, the project provides numerous significant issues to address, as well as the opportunity for improving the well-being and life conditions of SCD patients with reference to affecting their adherence to medications.

Indeed, the analysis of the effects that the HU therapy supported by the pill packaging technique produces, especially the effects that it has on pain management and adherence to the medication, will allow improving the current services for HU patients. As a result, if the combination of HU therapy with using pill packaging systems and a mobile app leads to increasing medication adherence, it is possible to expect the decrease in pain episodes in patients with SCD.

The application of the HU therapy enhanced by a pill packaging system and a mobile app may prompt the design of a new effective intervention to be used with SCD patients (Kutlar et al., 2019). This project promises great potential to provide a path to creating a more comfortable setting for addressing SCD-related concerns and helping patients to manage their condition while adding to both theory and practice.

There is a gap in research associated with the lack of literature on how pill packaging systems and mobile applications can relate to medication adherence (Haywood et al., 2014). However, this project contributes to addressing this gap, providing answers to the question of whether the application of pill packaging systems and mobile apps as reminders in patients with SCD can lead to increased medication adherence (Conn et al., 2015; Rich et al., 2015).

Furthermore, the project completion is significant for clinicians and practitioners working with SCD patients because the project provides an important opportunity to advance not only the understanding of the intervention but also practice of taking pills by patients (Huang, 2000; Nevitt, Jones, & Howard, 2017). The results of this project will be significant for professionals who work with patients with SCD who take hydroxyurea as there were no other studies on the relationship between HU therapy, pill packaging, using a mobile app and medication adherence (Lin et al., 2016). Therefore, it will be possible to improve the practice of providing HU therapy to guarantee taking pills regularly.

Rationale for Methodology

A quantitative methodology was chosen for the project to address the clinical question and determine the effects of applying HU therapy combined with pill packaging systems and the use of a mobile application on medication adherence in SCD patients. Thus, a quantitative methodology is more appropriate for conducting this project when comparing to a qualitative methodology and mixed methods because quantitative tools add to finding the relationships between independent and dependent variables (Trochim, Donnelly, & Arora, 2015).

A quantitative methodology allows for focusing on data provided in a numerical form, applying statistical tests to analyzing these data to make results more objective (Cokley & Awad, 2013). Finally, a quantitative methodology is effective to be applied when findings need to be generalized for a wider population, as it is typical in clinical practice (LibGuides, 2018; Trochim et al., 2015). As a result of using this methodology, the effects of the proposed intervention were analyzed thoroughly, causing possible changes in patients medication adherence to become evident.

The collection of quantitative data regarding the use of pill packaging systems in patients with SCD, as well as further statistical analysis of data, allows for concluding about the effectiveness of the combined intervention. Badawy et al. (2017) and Lê et al. (2015) among other researchers applied a quantitative method in order to examine different outcomes and effects of various interventions, including HU therapy, in patients with SCD.

Since the nature of the project is quantitative, it was possible to use a large sample size that allows for representing all target groups and embracing as many members of the SCD population as possible (Adesina, Brunson, Keegan, & Wun, 2017; Cokley & Awad, 2013). The proposed methodology helps find the relationship between applying HU therapy and pill packing systems, a mobile app, and adherence to the medication in SCD patients.

Nature of the Project Design

The design selected for this project is descriptive one to answer the clinical question on how the use of HU therapy combined with utilizing a pill packaging system and a mobile application can lead to increased medication adherence in patients with SCD. A descriptive approach was selected because it was necessary to apply the intervention (HU therapy combined with a pill packaging system and a mobile app) and describe how the intervention could be related to possible changes in patients medication adherence (Trochim et al., 2015).

Thus, a descriptive approach is effective to answer what-questions, therefore, it is appropriate to determine the outcomes of the intervention based on HU therapy and using pill packaging and a mobile app for medication adherence (Bell, Bryman, & Harley, 2018). In comparison to correlational or experimental designs, it requires the minimal involvement of an author and more time-efficient; it is the best choice to address the problem of using effective HU-based interventions for increasing medication adherence and addressing the pain crises (Bell et al., 2018; Cokley & Awad, 2013).

A descriptive design effectively supports the developed intervention based on using pill packaging and a mobile app as a solution to the practice problem of low medication adherence associated with pain episodes in SCD patients. The sample for this project included 75 patients with SCD who were asked to take hydroxyurea with the help of pill packaging systems and utilize the Mango Health mobile application for reminders. The data on the sample were collected with the help of a questionnaire developed by Huang (2000) in order to determine possible changes in patients medication adherence as a result of applying the intervention.

Definition of Terms

The following terms are used operationally in this project:

SCD

Sickle cell disease (SCD) is defined as a genetic red blood cell disorder caused by an autosomal recessive mutation that is likely to cause anemia unless appropriate measures are taken (Kutlar et al., 2019).

Hydroxyurea (Hydroxycaramide, HU)

It is a medication that allows for decreasing the number of pain episodes in patients with SCD due to affecting the red blood cells to make them round and rather flexible through increasing fetal hemoglobin and preventing blockages of blood vessels (Kutlar et al., 2019).

  • Pill packaging systems. A pill package system implies the use of some packages (such as blister packs or pill boxes) to help patients arrange their regular intake of medication (Conn et al., 2015).
  • Mango Health mobile application. Mango Health is a mobile application that offers users the information on their medication schedules and regimens and provides reminders (Kutty, 2020; Singh et al., 2016). Users of the app receive different types of rewards for taking their pills regularly (Haase, Farris, & Dorsch, 2017).
  • Medication adherence. Adherence to the medication is an extent to which patients take pills correctly, regularly, or according to a prescribed regimen with a focus on following directions strictly and taking pills on time (Badawy et al., 2017).

Assumptions, Limitations, Delimitations

The project has several limitations, most of which are linked directly to the methodology to be employed. The first limitation is associated with examining the results related to participants only in Charlotte, North Carolina. The second limitation is associated with the quantitative methodology and a descriptive design as incomplete records and questionnaire answers can affect the quality of statistical analysis, and incomplete data should be excluded.

Furthermore, due to the focus on obtaining complete and valid quantitative results, an important piece of information might be lacking. The limitations of the quantitative methodology do not allow for exploring qualitative changes in patients adherence to medication. The specified issues may be reviewed in a follow-up project addressing qualitative aspects of using a combination of HU and a pill packaging system, as well as using a mobile application. The timeframe in one month can also influence the results of the project, and further studies can be longer to receive more detailed information.

The key assumption that can be made at this point is that the adoption of the proposed intervention can have a positive outcome on medication adherence, consequently improving the quality of patients lives. Due to the changes in patients perception of taking pill regularly, individuals can have the likelihood of significantly changing their adherence to the medication. The integration of the specified pill packaging systems and a mobile application can facilitate reducing the levels of discomfort that SCD patients experience on a daily basis. As delimitations, the strategies for making the samples as diverse as possible and introducing methods for generalizing the end results should be used. It is believed that the selected approach leads to creating a comprehensive intervention for improving medication adherence in SCD patients.

Summary and Organization of the Remainder of the Project

The problem of SCD remains an unceasing threat to the well-being of people all over the world, including the population in the United States. The specific problem identified for this project is that it is not known whether a combination of HU therapy with a pill packaging system and a mobile application can have a positive impact on the adherence to hydroxyurea in patients with SCD. The reason is that the scope of SCD is large in the United States as this condition is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017).

The purpose of this quantitative descriptive project is to determine to what degree HU therapy combined with pill packaging and a mobile application can affect changes in the medication adherence of SCD patients, where the use of a pill packaging system and a mobile application is an independent variable, and medication adherence is a dependent variable. The clinical question formulated for this project is following: in patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?

The project has theoretical and practical significance for improving medication adherence in patients with SCD because of addressing the gaps in research and imporving clinical practice (Kutlar et al., 2019). A quantitative methodology and a descriptive design were chosen for the project to address the clinical question and the purpose and to determine the effects of applying the intervention on medication adherence in SCD patients. The enhancement of the intervention will enable the ability of patients to control their regular taking of hydroxyurea to improve their state and achieve positive results in addressing pain (Zhang et al., 2016).

This project is organized in a way to facilitate investigating the problem in depth by progressing from an overview of the issue with an analysis of the latest studies on the topic to a detailed consideration of the project methodology. Chapter Two will provide an overview of the current literature on the use of HU when in SCD patient treatment. Chapter Three will present the methodology that will be employed to address the set clinical question.

Chapter Four will include the graphic and written presentation of the results of this project. Chapter Five outlines the assessment of the findings along with discussion. Finally, the evaluation of the project results, recommendations for the implementation of SCD management practice, and considerations for further projects will be added. The layout of the chapters will be provided in the natural progression from the discussion of the problem to the assessment of the suggested solutions to the implications of the project results.

Literature Review

Sickle cell disease (SCD) affects a vast number of people, reducing the quality of their lives and increasing mortality rates drastically (Badawy et al., 2017; Hosseini et al., 2016). The problem of managing the disorder is fraught with numerous challenges that range from the necessity to address severe pain experienced by patients to the need of managing possible complications (Hosseini et al., 2016). Among the methods of managing the problem of SCD, taking hydroxyurea (HU) should be mentioned as a method of improving patients life quality by introducing a more elaborate pain management approach. Implementing an HU-based approach toward the management of SCD requires focusing on several aspects of the disease management simultaneously (McGann et al., 2016).

One of these aspects is adherence to the medication in SCD patients that can depend on a variety of factors, including the type of pill packaging systems used. The purpose of this quantitative descriptive project was to determine to what degree HU therapy combined with using a pill packaging system and a mobile application could affect possible changes in the adherenc

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