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Faculty of Medicine and Health Sciences

Prevalence of Insulin Adherence and the Associated Factors among Patients with Type 2 Diabetes Mellitus at Queen Elizabeth II Hospital,

Sabah

Yong Siew Yee

Master of Science 2020

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Prevalence of Insulin Adherence and the Associated Factors among Patients with Type 2 Diabetes Mellitus at Queen Elizabeth II Hospital, Sabah

Yong Siew Yee

A thesis submitted

In fulfilment of the requirements for the degree of Master of Science (Nursing)

Faculty of Medicine and Health Sciences UNIVERSITI MALAYSIA SARAWAK

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i

DECLARATION

I declare that the work in this thesis was carried out in accordance with the regulations of Universiti Malaysia Sarawak. Except where due acknowledgements have been made, the work is that of the author alone. The thesis has not been accepted for any degree and is not concurrently submitted in candidature of any other degree.

………

Signature

Name: Yong Siew Yee

Matric No.: 17020087

Faculty of Medicine and Health Sciences Universiti Malaysia Sarawak

Date :

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ACKNOWLEDGEMENT

Throughout the writing of this thesis, I have received a great deal of support and assistance. First and foremost, I would like to thank Almighty God for giving me the

strength, knowledge, and opportunity to undertake this research study and to persevere and complete it satisfactorily. Without His blessings, this achievement would not have been possible.

In my journey towards this Master degree programme, I would like to express my sincere gratitude to my main supervisor, Dr. Greta Miranda Goh, senior lecturer at the Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak. She has been there providing her heartfelt support, motivation and invaluable guidance throughout my quest for knowledge of research and writing of this thesis. My sincere thank also goes to my co-supervisor, Dr. Loh Huai Heng, Associate Professor at the Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak for her encouragement and insightful comments in the completing this thesis.

I have the great pleasure in acknowledging my gratitude to the Ministry of Health, Malaysia, for granting me a scholarship and study leave with pay to pursue my postgraduate study.

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I would also like to express my sincere gratitude to Dr. Hj Razak Bin Tambi, Director of Queen Elizabeth II Hospital and Dr. Fung Yin Khet, Head of Medical Department of Endocrinology Unit in Queen Elizabeth II Hospital, for their support and cooperation in allowing me to achieve my goal.

Last but not least, I would like to thank my family, especially my husband, Chan Kien Loong, for their utmost encouragement and spiritual support throughout my life. This would not have been possible without their unwavering and unselfish love, and support is always given to me.

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ABSTRACT

Non-adherence to prescribed insulin treatments is the utmost important therapeutic problem to be resolved among patients with type 2 diabetes mellitus (T2DM). Inadequate adherence could elevate the progression of the disease, reduces the effectiveness of diabetes treatment and leads to early morbidity, poor quality of life, and imposes a significant burden on both the individual patient and the health care system. This study aims to examine factors influencing insulin adherence among patients with T2DM at the Diabetes Clinic, Queen Elizabeth II Hospital (QEH II). A cross-sectional study was conducted among T2DM outpatients who were on insulin treatments alone or combination with oral antidiabetic drugs (OADs) in the Diabetes Clinic, Queen Elizabeth II Hospital.

Data were collected via self-administered validated questionnaires using Medication Compliance Questionnaire (MCQ), Health Belief Model (HBM) Diabetes Scale, and Patient Health Questionnaire (PHQ-8). A total of 360 patients took part in this study. The majority were female (n=218, 60.6%) whose age ranged from 28 – 87 years (54.07 ± 13.62 years). There was a significant correlation between insulin adherence with all the HBM constructs. The identified factors that affected the HBM constructs towards insulin adherence were age, years of diagnosed diabetes, duration on insulin injection, insulin regimens, diabetes complications, and depressive symptoms. Overall, the perceived benefits, depression, and self-efficacy predicted 51.6% of the variance in insulin adherence.

Keywords: T2DM, insulin adherence, barriers, perceptions and beliefs, depression

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Status Kepatuhan Rawatan Insulin dan Faktor-Faktor yang Berkaitan di kalangan Pesakit Diabetes Mellitus Jenis 2 di Hospital Queen Elizabeth II, Sabah

ABSTRAK

Ketidak-patuhan rawatan insulin merupakan masalah terapeutik yang paling penting untuk diselesaikan di kalangan pesakit Diabetes Mellitus Jenis 2 (T2DM). Pematuhan yang tidak mencukupi mempercepatkan kemerosotan penyakit, mengurangkan keberkesanan rawatan diabetes dan membawa kepada morbiditi awal, kualiti hidup yang tidak baik, dan memberi beban yang signifikan kepada pesakit individu dan sistem penjagaan kesihatan. Kajian ini bertujuan untuk mengenal pasti faktor-faktor yang mempengaruhi kepatuhan insulin di kalangan pesakit T2DM di Klinik Diabetes, Hospital Queen Elizabeth II (HQE II). Kajian kuantitatif dengan menggunakan pendekatan keratan rentas dilakukan di kalangan pesakit luar T2DM yang menjalani rawatan insulin sahaja atau kombinasi dengan OAD di Klinik Diabetes, Hospital Queen Elizabeth II. Data dikumpul melalui soal selidik Medication Compliance Questionnaire (MCQ), Skala Diabetes Health Belief Model (HBM), dan Patient Health Questionnaire (PHQ-8).

Sejumlah 360 pesakit mengambil bahagian dalam kajian ini. Majoriti adalah wanita (n=218, 60.6%) dengan julat usia 28 - 87 tahun (54.07 ± 13.62). Terdapat korelasi yang signifikan antara pematuhan insulin dengan semua HBM. Faktor yang dikenal pasti mempengaruhi HBM terhadap pematuhan insulin adalah umur, tahun menghidap diabetes, tempoh suntikan insulin, rejimen insulin, komplikasi diabetes, dan gejala murung. Secara keseluruhannya, perceived benefits, keyakinan diri dan depresi meramalkan 51.6%

daripada varians dalam pematuhan insulin.

Kata kunci: T2DM, kepatuhan kepada insulin, halangan, persepsi, kepercayaan, murung

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TABLE OF CONTENTS

Page

DECLARATION i

ACKNOWLEDGEMENT ii

ABSTRACT iv

ABSTRAK v

TABLE OF CONTENTS vi

LIST OF TABLES xi

LIST OF FIGURES xii

LIST OF ABBREVIATIONS xiii

CHAPTER 1: INTRODUCTION 1

1.1 Study background 1

1.2 Problem statement 2

1.3 Research objectives 4

1.3.1 General objective 4

1.3.2 Specific objectives 4

1.4 Research questions 4

1.5 Significance of the study 5

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vii

1.6 Operational definitions 6

1.6.1 Type 2 diabetes mellitus (T2DM) 6

1.6.2 Insulin treatment 6

1.6.3 Adherence 6

1.6.4 Perceptions and beliefs 7

1.6.5 Depression 7

1.7 Summary 8

CHAPTER 2 : LITERATURE REVIEW 9

2.1 Chapter overview 9

2.2 Type 2 diabetes mellitus 10

2.3 Adherence versus compliance 11

2.4 Prevalence of non-adherence to insulin treatment 13

2.5 Factors associated with insulin non-adherence 16

2.5.1 Patient-related factors 17

2.5.2 Diabetes-related factors 20

2.5.3 Social / economic-related factors 23

2.5.4 Health care team and system-related factors 24

2.6 Measurement of insulin adherence 25

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2.7 Theoretical framework related to insulin adherence 27

2.8 Predictors of insulin adherence based on the HBM 34

2.9 Summary 36

CHAPTER 3 : MATERIALS AND METHODS 37

3.1 Chapter overview 37

3.2 Research design 37

3.3 Research setting and study population 38

3.3.1 Inclusion and exclusion criteria 38

3.3.1.1 Inclusion criteria 38

3.3.1.2 Exclusion criteria 39

3.4 Sampling method 39

3.5 Sample size 41

3.6 Research instruments 42

3.6.1 Section A: Demographic and medical characteristics 43 3.6.2 Section B: Medication Compliance Questionnaire (MCQ) 43 3.6.3 Section C: Health Belief Model (HBM) Diabetes Scale 43

3.6.4 Section D: Patient Health Questionnaire (PHQ-8) 44

3.7 Pilot Study 45

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3.8 Data collection 47

3.9 Data analysis 48

3.10 Ethical consideration 50

3.11 Summary 50

CHAPTER 4 : RESULTS 52

4.1 Chapter overview 52

4.2 Demographic characteristics 52

4.3 Medical characteristics 53

4.4 Prevalence and reasons for insulin non-adherence 55

4.5 Perceptions and beliefs on insulin treatments 58

4.6 Correlation of the HBM constructs and insulin adherence 61 4.7 Comparison of patients’ perceptions and beliefs towards insulin

adherence based on the demographic characteristics, diabetes-related factors, and depressive symptoms

62

4.8 Prediction of insulin adherence based on the HBM constructs and depression

66

4.9 Summary 67

CHAPTER 5 : DISCUSSION AND CONCLUSION 68

5.1 Chapter overview 68

5.2 Summary of major findings 68

5.3 Prevalence of insulin adherence among T2DM patients 69

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5.4 Perceptions and beliefs in relation to insulin adherence 73 5.5 Comparison of patients’ perceptions and beliefs towards insulin

adherence based on the demographic characteristics, diabetes-related factors, and depressive symptoms

77

5.5.1 Age 78

5.5.2 Gender 79

5.5.3 Duration of diabetes and insulin injection 80

5.5.4 Diabetes treatment type and the complexity of insulin regimen 81

5.5.5 Diabetes complications 83

5.5.6 Co-morbidities and depression 84

5.6 Predictors of insulin non-adherence among patients with T2DM 87

5.7 Strengths and limitations 89

5.8 Implications for practice and protocol 91

5.9 Recommendation for future research 93

5.10 Conclusion 95

REFERENCES 96

APPENDICES 110

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xi

LIST OF TABLES

Page

Table 3.1 Cronbach’s alpha reliability of scales 46

Table 4.1 Demographic characteristics of survey participants (n=360) 53 Table 4.2 Medical characteristics of survey participants (n=360) 54 Table 4.3 Summary of the MCQ score and insulin adherence status (n=360) 55 Table 4.4 Range, mean and standard deviation of the MCQ (n=360) 55 Table 4.5 MCQ scores obtained by the study samples (n=360) 56 Table 4.6 Descriptive analysis of reasons for insulin non-adherence 57 Table 4.7 Range, mean and standard deviation of the HBM constructs

(n=360)

58 Table 4.8 Patients’ perceptions and beliefs by using the HBM diabetes scale

(n = 360)

60 Table 4.9 Matrix of correlation coefficient of the HBM constructs and

insulin adherence (n=360)

62 Table 4.10 Mean and standard deviation on insulin adherence and the HBM

constructs based on the patients’ characteristics (n = 360)

65 Table 4.11 Results of stepwise regression analysis on predictors of insulin

adherence based on the HBM constructs and depression (n=360)

66

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LIST OF FIGURES

Page

Figure 2.1 Main variables of the Theory of Planned Behaviour (Ajzen, 1985) 27

Figure 2.2 Social Cognitive Theory (Bandura, 1989) 28

Figure 2.3 Constructs of the Health Belief Model (Nutbeam & Harris, 2003) 30 Figure 2.4 A conceptual framework on factors associated with insulin

adherence among patients with T2DM

34

Figure 3.1 The flow of recruitment process 41

Figure 3.2 The flow of data collection 48

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xiii

LIST OF ABBREVIATIONS

T2DM Type 2 Diabetes Mellitus

HCPs Health Care Professionals

HBM Health Belief Model

QEH II Queen Elizabeth II Hospital

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CHAPTER 1 INTRODUCTION 1.1 Study background

Health care professionals (HCPs) expect patients with type 2 diabetes mellitus (T2DM) to have an adequate understanding of the disease and its treatment option available. These expectations include understanding the role of anti-diabetic medications in controlling glycemia and the complications of uncontrolled hyperglycemia. Review of the literature show that patients with T2DM often fail to adhere to their prescribed insulin treatment (Ahmad, Ramli, Islahudin & Paraidathathu, 2013; Brod, Rana & Barnett, 2012;

Spollett, Edelman, Mehner, Walter & Penfornis, 2016). Although with the availability of pharmacological anti-diabetic agents, the effectiveness of diabetic management will remain to be a challenge to the HCP especially where insulin treatment is concerned without the commitment and accountability of the patients themselves. Interestingly, Chakrabarti (2014) explained that adherence is a more positive, proactive behaviour of a patient to

follow through with the prescribed treatment while taking responsibility for their well-being. In contrast, compliance is a negative and passive behaviour in which a patient

follows a list of instructions from the doctor (Chakrabarti, 2014). Therefore, to achieve behavior change in adhering to insulin adherence, T2DM patient empowerment may play an important role in improving the clinical outcomes in diabetes management.

Co-morbidities such as hypertension and dyslipidaemia also have a significant impact on insulin adherence rate (Ahmad et al., 2013; Chew, Hassan & Sherina, 2015;

Davies et al., 2013). According to de Groot et al. (2010), the presence of diabetes doubles

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2

influence diabetes outcomes and increase mortality among diabetic patients. This is because a diagnosis of T2DM can lead to emotional distress regarding lifestyle modifications and adjustments with social networks (Wingert et al., 2015). Yet, even though the prevalence of co-morbid depression in patients with T2DM has increased over the years (Al-Amer, Sobeh, Zayed & Al-Domi, 2011), this phenomenon is often not being investigated in the current literature.

Numerous studies (Ahmad et al., 2013; Alqarni, Alrahbeni, Qarni & Qarni, 2019;

Asche, LaFleur & Conner, 2011; Tewabe & Kindie, 2018) have also investigate factors influencing insulin adherence among T2DM patients. The common factors reported to influence insulin adherence include age, education level, duration of diabetes, forgetfulness, fear of injection, and complexity of the insulin regimen. Likewise, other studies (Alatawi, Kavookjian, Ekong & Alrayees, 2015; Ashur, Shah, Bosseri, Morisky &

Shamsuddin, 2015) also revealed that majority of the T2DM patients may have different misperceptions and beliefs of their disease and their prescribed treatments. Therefore, this study will address the knowledge gap in the current literature by examining T2DM patients' perceptions and beliefs about their insulin treatment using the Health Belief Model (HBM).

1.2 Problem statement

T2DM is a progressive chronic disease caused by either the failure of the pancreas fails to produce enough insulin or the body cells are unable to utilise the insulin produced by the pancreas effectively, resulting in hyperglycaemia (ADA, 2012). Treatment for diabetes includes lifelong self-care practices in controlling and managing diabetes. Among these self-care activities, adherence to insulin treatment is the utmost important practice

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(MOH, 2015). Non-adherence to prescribed insulin treatment can compromise progression of the disease that may lead to early morbidity, poor quality of life, and imposes a significant burden on both the patient and country’s work-force (IDF, 2017).

It is reported that six million diabetes patients use either insulin alone or in combination with oral anti-diabetic drug (OAD) (IDF, 2017). In Malaysia, Ahmad et al.

(2013) reported that about 53.0% diabetic patients do not adhere to their insulin treatments, which is a major challenge confronting the health care professionals. Evidence from the literature showed that diabetic patients' perceptions and beliefs on their insulin treatments play a significant role on whether or not they adhere to their prescribed treatments (Rodriguez-Gutierrez et al., 2015; Tong, Vethakkan & Ng, 2015; Wong et al., 2011).

Therefore, understanding the T2DM patients’ perceptions and beliefs about their insulin treatment may help HCP to tailor insulin self-management to their T2DM patients effectively.

Thus far, although several studies about insulin adherence among T2DM patients have been carried out in West Malaysia (Ahmad et al., 2013; Chew et al., 2015), there has yet been any study conducted in East Malaysia, specifically in Sabah. In view of this, there is a great need to conduct this study in Sabah to uncover the prevalence of insulin adherence among T2DM patients and to identify the possible factors influencing patients’

perceptions and beliefs towards insulin adherence. This study was carried out in the Diabetes Clinic, Queen Elizabeth Hospital II (QEH II) as it is the main referral centre for patients with diabetes from all the primary health clinics in Sabah.

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4 1.3 Research objectives

1.3.1 General objective

This study aimed to examine factors influencing insulin adherence among patients with type 2 diabetes mellitus (T2DM) at the Diabetes Clinic, Queen Elizabeth Hospital II (QEH II).

1.3.2 Specific objectives

a. To determine the prevalence of insulin adherence and reasons for non- adherence among patients with T2DM.

b. To determine the relationship between Health Belief Model (HBM) constructs and insulin adherence.

c. To compare the insulin adherence rate and HBM constructs based on patient’s characteristics.

d. To identify the predictors of insulin non-adherence among patients with T2DM.

1.4 Research questions

a. What is the prevalence of insulin adherence and reasons for non-adherence among patients with T2DM?

b. What is the relationship between Health Belief Model (HBM) constructs and insulin adherence?

c. Is there any significant difference between the mean scores of insulin adherence

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rate and HBM constructs with patient’s characteristics?

d. What are the predictors of insulin non-adherence among patients with T2DM?

1.5 Significance of the study

This study aims to address the current knowledge gap in the literature on insulin adherence among T2DM patients. The importance of understanding insulin adherence begins with understanding the factors surrounding T2DM patients’ perceptions and beliefs about their diabetes management. Having a better understanding of the HBM-related factors on insulin adherence and how they differ between patients with T2DM with and/or without co-morbid depression broadens the scope of exploring insulin adherence treatment as it relates to the T2DM patients’ need on self-care activities / practices. The information from this study would also provide empirical evidence of the link between patient adherence or non-adherence to insulin treatment patients diagnosed with T2DM. Doctors and diabetic nurse educators can use the information to advocate for specific interventions that focus on improving patient adherence to prescribed medications. Those interventions would then be a major step toward combating the epidemic of diabetic complications.

Ultimately, this information can be used to provide a basis to guide the development of effective holistic educational programs and interventions to improve insulin adherence rate and communication between patients with T2DM and their health care providers about insulin treatment. An additional social change outcome would be improving the health outcomes for diabetic patients in Sabah.

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6 1.6 Operational definitions

Definitions are presented to clarify the terms used in this study and to assist readers to understand why such terms were used. These terms are listed below:

1.6.1 Type 2 diabetes mellitus (T2DM)

T2DM is a chronic disease and characterized by high levels of glucose in the blood (MOH, 2015). Patients with T2DM require lifestyle and dietary modifications, with or without the requirement of diabetes medications (OADs and insulin treatments).

In this study, patients with T2DM refer to out-patients who have been diagnosed with T2DM for at least one year and are receiving insulin alone for more than a year or in combination with OADs treatment.

1.6.2 Insulin treatment

It is one of the pharmacological treatments for diabetic patients to control their blood sugar levels. There are two types of insulin, conventional and analogue (BD, 2012).

In this study, the inclusion criteria for patients to be recruited in this study would be using either conventional or analogue insulin for at least a year as prescribed by their doctor.

1.6.3 Adherence

Adherence is defined by the WHO (2003) as the capacity and readiness of a patient to abide mutually and agree with the recommended treatment plan.

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In this study, Medication Compliance Questionnaire (MCQ) was used to measure the prevalence of insulin adherence among patients with T2DM. A total score of lower than 27 was considered as non-adherence.

1.6.4 Perceptions and beliefs

According to Vazini and Barati (2014), perceptions and beliefs refer to the foundation of how an individual think or understand something. Perceptions and beliefs varies across different people according to their personal background, education, knowledge, religion, and culture.

In this study, the T2DM patients' perceptions and beliefs on insulin adherence were determined by using the Health Belief Model (HBM) Diabetes Scales. Higher scores equates to positive perceptions and beliefs. Exception to this is perceived barriers, whereby, higher scores denotes more barriers to insulin treatments.

1.6.5 Depression

Depression is a common and serious medical illness that negatively affects how patients feel, the way they think and how they act (Kav et al. 2015). It causes feelings of sadness and/or a loss of interest in activities once enjoyed. It can lead to a variety of emotional and physical problems and can decrease a person’s ability to function at work and at home.

In this study, Patient Health Questionnaire-8 (PHQ-8) was employed to determine diabetic patients with depressive symptoms. The scores for each item are

summed to produce a total score between 0 and 24 points. A total score of 5 and above

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8 1.7 Summary

T2DM is an epidemic worldwide and has become a major non-communicable disease that affects patients of all ages. Diabetes treatment demands active involvement of the patients. However, non-adherence to prescribed therapeutic insulin regimen is the greatest challenge in the effective treatment of diabetic patients worldwide and has become a growing concern for all health care providers. Therefore, this study aims to explore further by looking into the T2DM patients' perceptions and beliefs towards insulin adherence.

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CHAPTER 2

LITERATURE REVIEW

2.1 Chapter overview

This chapter presents a review of the literature on insulin adherence among patients with T2DM. Search engines used to retrieve the literature for this study included Google Scholar, Pubmed, Science Direct, BioMed Central, and Medline. The keywords used for the literature review were type 2 diabetes mellitus, compliance and adherence, insulin adherence, barriers, perception and belief, and Health Belief Model. Besides that, the journal articles' reference list was used to guide in finding relevant articles to this study.

Literature search was limited to sources in the English language. References identified from the searches were screened initially according to the study title. The searches returned 3769 articles, of which 3507 were excluded. All accepted references were then screened according to abstract and subsequently on the basis of the full paper to judge inclusion suitability. At the abstract screen, 126 references were excluded. The main reasons for exclusion were that references were not relevant, the investigation studied adherence only to oral antidiabetic drugs (OADs), and the year of publication was more than 10 years.

Mostly, the dates of the published studies cited were from the years 1974 – 2019.

The years varied widely across the studies as the theoretical model, HBM used in the present study was widely published since the year 1974. Apart from that, the reviews also included the evolution of the terminologies 'compliance' and 'adherence' since around the 1975s. It is important to understand the concept of these two terms before commencing the present study.

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