GOPD CARE OF TYPE 2 DIABETES MELLITUS PATIENTS IN JUTH-Effect of Patient-Centred-Care on Glycaemic control and Quality of Life

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GOPD CARE OF TYPE 2 DIABETES MELLITUS PATIENTS IN JUTH-Effect of Patient-Centred-Care on Glycaemic control and Quality of Life 

ABSTRACT

Background: Type 2 diabetes mellitus (T2DM) is a common chronic disease in Nigeria. The Routine Care usually given to the patients does not result in good glycaemic control in a majority of them. Better glycaemic control had been observed in patients who received Patient-Centred Care (PCC) in some studies.

Objective: The objective was to compare Patient-Centred-Care (PCC) intervention addressing nutrition and exercise with Routine Care in terms of glycaemic control and quality of life (QOL) of patients with T2DM in the General Out Patients Department (GOPD) of the Jos University Teaching Hospital (JUTH).

Design: A total of 74 adults with type 2 diabetes mellitus with a mean age of 49.9 years were randomly assigned to the intervention group or the control group. All participants received basic diabetes education. The subjects in the intervention group participated in a weekly nutrition and exercise classes (60 minutes each session). Subjects for whom it was deemed safe, apart from individual daily walking exercises, also participated in a weekly training program conducted on a diamond back cycle ergometer starting with the heart rate associated with 55% of their initial maximum volume of oxygen (VO2max) for 30min/day and gradually increasing to the heart rate associated with 75% of their initial VO2max for 50min/day at the end of week 12. They maintained this intensity and duration throughout the remaining period of the trial. Glycated haemoglobin, fasting blood glucose, height, weight, body mass index (BMI), and blood pressure were measured at baseline and the end of the study (after 12 weeks).

Results: The intervention group lost 3±15.8kg compared with a weight gain in the control group of 0.4±13.2kg (P<0.05). Fasting blood glucose decreased 116±32.86mg/dL in the intervention group and increased 38.0±35.3mg/dL in the control group (P= 0.000). Glycated haemoglobin decreased 2.8±1.7% in the intervention group and increased 1±1.6% in the control group (P=0.000).The quality of life scores improved in the intervention group compared to the control group (p<0.05).

Conclusions: Glycaemic control and quality of life of type 2 diabetes mellitus patients can be improved through Patient-Centred-Care intervention addressing nutrition and exercise.

TABLE OF CONTENT

Title page

Declaration --------------------------------------------------------------------------------------          i

Dedication --------------------------------------------------------------------------------------           ii

Acknowledgement ------------------------------------------------------------------------------         iii

Certification 1 -----------------------------------------------------------------------------------         iv Certification II ----------------------------------------------------------------------------------   v

Table of contents -------------------------------------------------------------------------------          vi

List of figures -----------------------------------------------------------------------------------          xi

List of tables ------------------------------------------------------------------------------------          xii

List of abbreviations ---------------------------------------------------------------------------          xiii

Abstract ------------------------------------------------------------------------------------------          xv

CHAPTER ONE

1.0       Introduction -----------------------------------------------------------------------------        1

1.2       Justification for the study --------------------------------------------------------------       8

1.3       Aim and objectives of study -----------------------------------------------------------       9

1.3.1  General objectives ----------------------------------------------------------------------          9

1.3.2 Specific objectives ----------------------------------------------------------------------          9

1.4       Relevance of study to family medicine ----------------------------------------------        9

CHAPTER TWO

2.0       Literature review ------------------------------------------------------------------------       11

2.1     Diabetes mellitus overview --------------------------------------------------------------       11

2.2     Risk factors --------------------------------------------------------------------------------       11

2.3    Pathogenesis --------------------------------------------------------------------------------       13

2.4    Clinical features of diabetes mellitus --------------------------------------------------         14

2.4.1    History ---------------------------------------------------------------------------------           14

2.4.2    Physical findings -----------------------------------------------------------------------         14

2.5     Laboratory tests ------------------------------------------------------------------------           15

2.5.1 Blood glucose measurements --------------------------------------------------------             15

2.5.2 Glycated haemoglobin (HbA1c) -----------------------------------------------------             16

2.5.3 Test to identify type of diabetes -----------------------------------------------------             16

2.6       Classification of diabetes mellitus ---------------------------------------------------         17

2.7     Management of type 2 diabetes mellitus --------------------------------------------          17

2.8       Complications of diabetes mellitus -------------------------------------------------          18

2.9       Exercise and type 2 diabetes (T2DM) -----------------------------------------------        30

2.9.1 Health benefit of exercise ------------------------------------------------------------             31

2.9.2 Types of exercise ----------------------------------------------------------------------             31

2.9.2.1 Aerobic exercise -----------------------------------------------------------------------         31

2.9.2.2 Resistance exercise --------------------------------------------------------------------         32

2.9.2.3 Flexibility exercise --------------------------------------------------------------------          32

2.9.3  Acute effects of exercise -------------------------------------------------------------            32

2.9.4 Post exercise glycaemic control/ blood glucose levels (BG) Levels ----------              33

2.9.5  Chronic effects of exercise training --------------------------------------------------          34

2.9.5.1 Pre-exercise evaluation ---------------------------------------------------------------          36

2.9.6 Recommended physical activity (PA) participation for persons with T2DM ---          38

2.9.6.1 Aerobic exercise training --------------------------------------------------------------        38

2.9.6.2   Resistance exercise training ---------------------------------------------------------        40

2.9.6. 3 Combined aerobic and resistance and other types of training -----------------           41

2.9.6.4   Daily movement (unstructured activity) ---------------------------------------------      41

 

2.9.6.5 Flexibility training ------------------------------------------------------------------------     41

2.9.6.6 Exercise with non-optimal BG Control ------------------------------------------------     42

2.9.6.7 Medication effects on exercise responses ---------------------------------------------      43

2.9.6.8 Adoption and maintenance of exercise by persons with diabetes ---------------         44

2.10      Diet and diabetes --------------------------------------------------------------------------- 46

2.10.1  Goals of medical nutrition therapy (MNT) ------------------------------------------       46

2.10.2 Requirements from the food groups ---------------------------------------------------       47

2.10.2.1 Carbohydrate in diabetes management ----------------------------------------- ---        47

2.10.2.1.1 ------------------------------------------------------------------------------------------       48

2.10.2.2 Fibre -------------------------------------------------------------------------------------       49

2.10.2.3 Sweeteners -----------------------------------------------------------------------------        50

2.10.2.4 Protein in diabetes management -----------------------------------------------------       50

2.10.2.5 Dietary fat and cholesterol in diabetes management ------------------------- --       51

2.10.2.6 Sodium --------------------------------------------------------------------- -----------         52

2.10.2.7   Alcohol in diabetes management -----------------------------------------------            53

2.10.2.8   Optimal mix of macronutrients ---------------------------------------- ----------          53

2.10.2.9   Micronutrients in diabetes management --------------------------------------             54

2.10.2.10  Antioxidants in diabetes management ------------------------------- ---------           54

2.10.2.11  Chromium, other minerals, and herbs in diabetes management --------                55

2.11         General dietary guidelines -------------------------------------------------------           55

2.12        Anthropometrics and dietary recommendations ----------------------------               57

2.12.1     Underweight (BMI<18.5 Kg/m2) ------------------------------------------------           57

2.12.2     Overweight (BMI>25 Kg/m2) ----------------------------------------------------           57

2.12.3     Normal weight (BMI 18.5 – 24.9 Kg/m2) --------------------------------------            58

2.13        Patient-Centred T2DM care addressing nutrition and exercise ------------              59

CHAPTER THREE

Methodology -----------------------------------------------------------------------------------           63

3.1       Study area -----------------------------------------------------------------------------           63

3.2    Study population ----------------------------------------------------------------------             63

3.3       Study period ---------------------------------------------------------------------------          64

3.4     Eligibility ------------------------------------------------------------------------------             64

3.4.1    Inclusion criteria ----------------------------------------------------------------------           64

3.4.2 Exclusion criteria ---------------------------------------------------------------------              64

3.5       Sample size determination -----------------------------------------------------------          64

3.6       Ethical consideration ------------------------------------------------------------------         65

3.7        Instruments of data collection ------------------------------------------------------          65

3.8       Sample method and randomisation ------------------------------------------------           66

3.9       Data collection ------------------------------------------------------------------------           69

3.10     Method of data analysis -------------------------------------------------------------           71

CHAPTER FOUR

4.0       Results -------------------------------------------------------------------------------              72

4.1       Characteristics of patients at -----------------------------------------------------               73

4.2       Clinical characteristics of patients -----------------------------------------------              74

CHAPTER FIVE

Discussion --------------------------------------------------------------------------------------           82

5.1       Demographic characteristics of patients at baseline. --------------------------              82

5.1.1   Age and age groups -----------------------------------------------------------------              82

5.1.2  Gender --------------------------------------------------------------------------------               82

5.1.3  Marital status -------------------------------------------------------------------------              83

5.1.      Level of education -------------------------------------------------------------------            83

5.1.5  Occupation ---------------------------------------------------------------------------               83

5.1.6  Duration of diabetes ----------------------------------------------------------------               84

5.2       Clinical characteristics of patients ------------------------------------------------            84

5.2.1 Mean HbA1c and FBG --------------------------------------------------------------               84

5.2.2 Body weight and body mass index (BMI) --------------------------------------                 85

5.2.3 Blood Pressure -----------------------------------------------------------------------               86

5.2.4 Quality of life (QOL) ---------------------------------------------------------------                87

5.3        Strengths and limitations of the study -------------------------------------------             87

5.4       Implications of Study for Family Medicine ------------------------------------              88

5.5     Future research --------------------------------------------------------------------                  88

5.6       Conclusion --------------------------------------------------------------------------              89

5.7       Recommendations -----------------------------------------------------------------               89

References -----------------------------------------------------------------------------------               90

CHAPTER ONE

1.0       INTRODUCTION

The term Diabetes Mellitus (DM) describes a metabolic syndrome of multiple aetiologies characterized by chronic hyperglycaemia due to disturbance of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, and or insulin action or both.1 Symptoms of marked hyperglycaemia include polyuria, polydipsia, weight loss, polyphagia and blurred vision. Impairment of growth and susceptibility to certain infections may also accompany chronic hyperglycaemia. Acute life threatening consequences of uncontrolled DM are hyperglycaemia with ketoacidosis or the nonketotic hyperosmolar syndrome.

Long term complication of DM include retinopathy with potential loss of vision, nephropathy leading to renal failure, peripheral neuropathy with risk of foot ulcers and amputations, Charcot joints and autonomic neuropathy causing gastrointestinal, genitourinary, cardiovascular symptoms, and sexual dysfunction. Patients with DM have an increased incidence of

atherosclerotic cardiovascular, peripheral arterial and cerebrovascular disease.  Hypertension and abnormalities of lipoprotein metabolism are often found in people with DM.2 The new classification identifies four types of DM; type I DM (T1DM), type II DM (T2DM), gestational

DM (GDM) and “other specific types.”2,3 The risk factors for DM include: impaired fasting glucose, impaired glucose tolerance, family history of DM, body mass index (BMI) greater than 25kg/m2, sedentary life style, hypertension, dyslipidaemia, history of GDM or large for gestational age infant and polycystic ovary syndrome, Blacks, Latin Americans, Native Americans, and

Asian-Pacific islanders.3,4

The number of people with DM is increasing due to population growth, aging, urbanization and increasing prevalence of obesity and physical inactivity. The prevalence of DM for all age groups worldwide was found to be 2.8% in 2000 and estimated to be 4.4% by 2030. The total number of people with DM is projected to rise from 171 million in 2000 to 366 million in 2030 and most of this increase is expected to be in the developing countries.4 The reasons behind this increase are not country-specific but the consequence of population ageing, increasing urbanization, unhealthy diets, obesity and sedentary lifestyle.4 The prevalence of DM is higher in men than in women. The urban population in developing countries is projected to double between 2000 and 2030. The most important demographic change to DM prevalence across the world appears to be the increase in the proportion of people older than 65 years of age. The developing world accounted for 14 million people with DM (72.5% of the world total) in 2003. During this period, (2000-2030), the number of people with DM is projected to double in three of the six developing regions:  the Middle East and North Africa, South Asia, and sub- Saharan Africa. 5, 6

Although the exact magnitude of the problem in Africa is not well understood, DM is a serious threat to the public health throughout the continent. In 2003, the international diabetes foundation (IDF), predicted that by 2010, DM prevalence in Africa would increase by around 95%. Ignoring DM could lead to the breakdown of the fragile health systems in Africa, which already are overwhelmed by communicable disease such as tuberculosis, malaria and HIV/AIDS.5,6 DM was once regarded as a disease of the affluent but is now vastly visible as a growing health problem in developing economies as almost 80% of DM deaths occur in low and middle income countries, of which Nigeria is one.7  Available report has shown that Nigeria presents with the largest number of DM in Africa, 7 with a prevalence in adults (aged > 40 years) in 2000 of 6.8%.8 T2DM has reached epidemic proportions worldwide, 7 and it is the predominant form of diabetes in subSaharan Africa, accounting for over 90% of cases.7 In Nigeria about 1-7% of the population is afflicted by DM, with over 90% being T2DM.8 The WHO 2004 report estimates that 1.7million people in Nigeria have DM, with the projection that the number will triple by 2030.5 Puepet et al, in 2004 reported a prevalence rate of 10.3% in urban adults in Jos metropolis. 9 Initial interventions in the treatment T2DM is recommended to include both life style modification and metformin therapy, provided the later is not contraindicated, and is titrated for optimum tolerability and efficacy. If glycaemic control is not achieved (within 2-3 months) or sustained then additional medication which is likely to be a sulphonylurea or a thiazolidinedione is needed. Where oral therapy is inadequate or hyperglycaemia is marked (e.g. HbAIC > 8.5%) or causing symptoms, then basal insulin therapy is advised.10, 11

Inspite of the availability of modern drugs, insulin, monitoring devices, physical activity aids, “health diets” and treatments for comorbid conditions, a large proportion of people with diabetes mellitus continue to have poor control.12 People with diabetes sometimes choose not to take any form of treatment. Others prefer to take complementary and alternative medicine of unproven efficacy, rather than use modern evidence-based therapies. Yet others do take modern drugs but in suboptimal frequency and dosage, or avoid insulin, preferring to continue oral drugs even when such drugs have lost their efficacy. All such patients have poor glycaemic control and suffer from easily avoidable symptoms, acute complications, poor quality of life, depression, and micro- as well as macro- vascular diseases.12 Poor satisfaction with health care professionals, and lack of communication with health care providers, are associated with poor adherence with suggested therapy and suboptimal glycaemic control.12

The Patient-Centred-Care (PCC) is a health care model that establishes a partnership between the practitioner, patients and their families (where appropriate) to ensure that decisions respect patients’ wants, needs, and preferences and that  the patients have the education and support to make decisions concerning their care.13 The Institute Of Medicine (IOM) defines PCC as the “care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide all clinical decisions.”14 Balint and colleagues15 first introduced the term ‘Patient-Centred-Medicine in 1970 and contrasted it with Disease-Centred- Medicine. They described an understanding of the patients complaints based on patient centred thinking as the overall diagnosis, while an understanding based on disease centred thinking was called ‘traditional diagnosis’. Clinical technique in medical schools has historically emphasized a doctor – centred approach (diseased – centred).15 According to this model, physicians ascertain the patient’s complaints and seek information on what will enable them to interpret the patient’s illness solely within the physician’s frame of reference. This involves diagnosing the patient’s disease and prescribing an appropriate management. In contrast, PCC seeks both a diagnosis as well as an understanding of the patient’s experience of being ill. Disease and illness are intertwined and therefore, cannot be artificially separated. 15

The six interactive components of PCC are as follows: - 15

  1. Exploring both the disease and the illness experience
    • History, physical examination, laboratory tests
    • Dimensions of illness (Feelings, Ideas, effects on Function and Expectations,

(FIFE)).

  1. Understanding the whole person
    • The person (Example – life history, personal and developmental issues)
    • The proximal context (Example; family, employment, social support)
    • The distal context (Example: - culture, community, ecosystem).
  2. Finding common ground
    • Problems and priorities
    • Goals of treatment and / or management
    • Roles of patient and doctor
  3. Incorporating prevention and health promotion
    • Health enhancement
    • Risk avoidance
    • Risk reduction
    • Early identification
    • Complication reduction
  4. Enhancing the patient – doctor relationship
    • Compassion
    • Power
    • Healing
    • Self – awareness
    • Transference and counter transference
  5. Being realistic
    • Time and timing
    • Team building and team work
    • Wise stewardship of resources

For most chronic illnesses, therapeutic success is traditionally measured by disease-free and overall survival, and control of major physical symptoms. While these factors play a primary role in such evaluations, efforts have been made to assess the extent to which chronic diseases and their treatments affect patient’s functional capacity, psychological and social health, and sense of wellbeing or quality of life (QOL).16  The WHO defines QOL as an individual’s perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards and concerns.17 It could also mean the “degree to which a person enjoys the important possibilities of her/his life.”18 Further still, QOL has been defined as a “descriptive term that refers to people’s emotional, social and physical well being and their ability to function in the ordinary tasks of living.”19

These different definitions of QOL stem from the multi-disciplinary use of the term. Another reason is the fact that life itself is complex and its importance to every individual is highly subjective. According to Farquhar “there are four main types of definition; global, component, focused, and combinational. The global is the most commonly used in defining quality of life. It allows for encompassing many different facets of the QOL, however, it over generalizes and does not allow enough specificity of the major components to use it practically. The component definition attempts to break down the QOL into specific elements in terms of dimensions and characteristics dependant on specific purposes, such as research topics and measurement for longterm project or policy. The limitation of the component approach is the reliability and validity of each component in the measure of QOL. Focused definitions use only one or a small number of components to define the QOL. This component approach is often used to define a very specific QOL, such as that of a cancer patient, or one in hospice care. The drawback to this is that it is a very narrow definition and in some cases authors use it too broadly and attempt to extend it into a broader interpretation of the QOL. The final version, the combination or hybrid, is created by combining global and component types. This includes the attendant advantages and disadvantages of both.”20

However, there is a consensus among researchers that an individual’s happiness and satisfaction with life are the two major building blocks in defining QOL. 21 Health related quality of life (HRQOL) on the other hand includes domains (aspects) of life that improve when a treatment option is successful.22 A clinically significant change in HRQOL is indicated by a decline in a domain that leads a physician or health care provider to alter a medication or medical treatment. HRQOL domains minimally include functional status (e.g., whether a patient is able to manage a household, use the telephone, or dress independently), mental health or emotional wellbeing (e.g., depressive symptoms, positive affect), social engagement (e.g. involvement with others, engagement in activities), and symptom states (e.g., pain, shortness of breath, fatigue). These domains represent typical outcomes in medical and social science research.22 DM is a demanding disease that affects a person’s HRQOL, a person’s ability to function and to desire satisfaction from doing so.16 People with DM are constantly reminded of the disease on a daily basis, they have to eat carefully, exercise, test their blood glucose and based on the result decide when to schedule their next meal or medication. Furthermore, they often have to stop and check for symptoms of hypo or hyperglycaemia as well as deal with the fears of the possibility of complication of the disease.23 Numerous studies have been done to evaluate the effect of DM on the sufferer’s QOL in the developed world.23 In contrast; studies relating to the HRQOL of patients with DM in developing countries are limited. 23 The QOL of patients with DM is adversely affected by physical complications, lower income, lower education and low rated employment.16

There is paucity of data on the effects of PCC on the glycaemic control and QOL of patients with T2DM in Nigeria. However, studies done elsewhere have shown various results, for example Griffin et al 24 demonstrated that the way patients and practitioners behaved in consultations had measurable effects both negatively and positively on the health outcome of the patients.  Gensichen and colleagues25 concluded that setting goals, proactive follow up and communicative support may influence the glycaemic control and other outcomes among diabetics. Prueksaritanond and colleagues26 found that glycaemic control of T2DM subjects was improved with PCC.

1.2       JUSTIFICATION FOR THE STUDY: 

Nigeria with a population of more than 140million people, 27 is Africa’s most populous country.

Life expectancy at birth is 47years. About 60% of the population lives below the poverty line. While health care institutions are inadequate, and there is a chronic lack of skilled healthcare personnel, DM is on the increase.28 This increasing prevalence of T2DM is a growing public health burden plaguing both developed and developing countries at an alarming rate, 29 imposing a significant medical and economic impact on health care systems.30 T2DM is a chronic debilitating disease, necessitating life-long therapy.  Despite the availability of multiple classes of medications and other effective therapies, despite the fact that effective glycaemic management reduces the risk of diabetes-related complications, many patients with T2DM fail to attain or maintain glycaemic control overtime.30-34 This raises their risk of disease progression with attendant potentially serious microvascular and macrovascular complications. These literally cripple these individuals causing enormous human suffering and socioeconomic burden, while placing a huge strain on the economy of their families. 30 The well-being of the family is thus consequently

affected.

This study seeks to provide data from Nigeria on the impact of PCC compared with Routine Care in QOL of patients with T2DM, in primary care.

 1.3      AIM AND OBJECTIVES OF STUDY

1.3.1   Aim or General Objective

To compare Patient-Centered-Care with Routine Care in terms of glycaemic control and quality of life in patients with T2DM in JUTH.

1.3.2 Specific Objectives

  1. To compare the mean HbA1c level of patients with T2DM at 12 weeks randomized to PCC or Routine Care.
  2. To compare the mean fasting blood glucose (FPG) of patients with T2DM at 12 weeks randomized to PCC or Routine Care.
  3. To assess the effect of PCC on body mass index (BMI) and blood pressure control.
  4. To compare the mean QOL scores of patients with T2DM patients at 12 weeks randomized to PCC or Routine Care.

1.4       RELEVANCE OF STUDY TO FAMILY MEDICINE

Providers often struggle to give the recommended level of DM care within the constraints of a busy office setting. Because our health care system is designed to deliver acute, symptom-driven care, it is poorly configured to effectively treat chronic diseases such as DM that requires the development of a collaborative daily self-management plan. Providers also struggle with the realities of dealing with a chronic disease for which daily care is in the hands of the patient. Inspite of our attempts to encourage, cajole, and persuade patients to perform self-care tasks, we are often frustrated and discouraged when patients are unwilling to follow our advice and achieve the desired outcomes.34

Traditionally, the success of patients to manage their DM has been judged by their ability to adhere to a prescribed therapeutic regimen. Unfortunately, this approach does not match the reality of DM care. The serious and chronic nature of DM, the complexity of its management, and the multiple daily self-care decisions that DM requires mean that being adherent to a predetermined care program is generally not adequate over the course of a person's life with DM. This is particularly true when the self-management plan has been designed to fit patients' DM, but has not been tailored to fit their priorities, goals, resources, culture, and lifestyle.34

To manage DM successfully, patients must be able to set goals and make frequent daily decisions that are effective and fit their values and lifestyles, while taking into account multiple physiological and personal psychosocial factors. Intervention strategies that enable patients to make decisions about goals, therapeutic options, and self-care behaviors and to assume responsibility for daily DM care may be more effective in helping patients care for themselves.

This is what PCC is all about. PCC is an essential attribute of family medicine which emphasises putting the patient in the centre stage in his or her own care. PCC ensures that the patients are well informed and take active roles in the management of their DM and the health care providers are prepared, proactive and supportive. Once these patients leave the clinic or office, they are less likely to veto any of the multiple self- care recommendations that providers make, as it is the case with the current commonly practiced Routine or Provider-Centered care. FM respects patients’ value and concerns and puts the patients in center stage. Hence PCC is exploring some of these virtues of FM.

GOPD CARE OF TYPE 2 DIABETES MELLITUS PATIENTS IN JUTH-Effect of Patient-Centred-Care on Glycaemic control and Quality of Life

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