Psychosocial Predictors Assessment and Mitigation

of Problems Among Diabetes Clients

A SAMPLE RESEARCH PROJECT

Protocol Developed By:

Ram Sharan Mehta

Additional Professor Medical Surgical Nursing Department

College of Nursing

B.P. Koirala Institute of Health Sciences Dharan, Sunsari, Nepal Email: ramsharanmehta7@yahoo.com

Phone: 9842040537, 025-525555-Ext. 3022

Fax No: 025520251

2012

1. Title of the Study: Psychosocial Predictors Assessment and Mitigation of Problems Among Diabetes Clients. 2. Introduction: Background: Between 1995 and 2025 the number of the adult population affected by diabetes mellitus in developing countries is projected to grow by 170%, from 84 to 228 million people. By 2025, these countries will be home to 76% of all persons with diabetes, as compared with 62% in 1995. In the same period, the developed world will see a 41% increase, from 51 to 72 million people. Diabetes Mellitus (DM) is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin production. It is a syndrome caused by an imbalance between insulin supply and demand, characterized by hyperglycemia and associated with abnormal carbohydrate, fat and protein metabolism. Insulin deficiency results in increased concentrations of glucose in the blood, which intern damage many of the body’s systems, in particular the blood vessels and Nerves.

DM is a major non-communicable disease affecting approximately 150 million people in world in 2002,180 million in 2003 and expected to reach 330 million in 2025. The prevalence of DM is steadily increasing world wide, particularly in developing countries. It is projected to increase by 170%, out of which 76% will be from developing countries. 310 patients were admitted in medical units of BPKIHS between 1-3-2003 to 29-2-2004. DM is a chronic disease that affects approximately 14 million people and among those 14 million, 7 million were un- diagnosed. Among older people (>65 years) 8.6 had type-II DM. Type-I DM approximately account for 10% and type-II 85-90% of all known cases of DM in United States. There is rising prevalence of the disease in the developing countries, which was rare before, is due to industrialization, Socio-economic development, and urbanization and changing life style. Type-II DM is more prevalent than type-I DM and constitutes nearly 90% of cases among the diabetes. The prevalence of diabetes increases with age. The prevalence of type-II DM in female was relatively lower (5.57%) than males (6.73%). The high incidence (new cases) of type-II DM in Nepal was found due to lack of public awareness regarding the problems and poor medical service in country2. From 28th oct.1997, to 27th Oct. 1998, in Medical OPD of B.P. Koirala Institute of Health Sciences, 1840 patients (1040 M & 800 F) attended with DM. Hence, the investigators tried to explore the various facts or problems of the admitted patients suffering with DM. Diabetes: Facts:

• At least 171 million people worldwide have diabetes; this figure is likely to be more than double by 2030.

• Around 3.2 million deaths every year are attributable to complications of diabetes; six deaths every minute.

• The top 10 countries, in numbers of sufferers, are India, China, USA, Indonesia, Japan, Pakistan, Russia, Brazil Italy and Bangladesh.

• Overall, direct health care costs of diabetes range from 2.5% to 15% of annual health care budgets, depending on local diabetes prevalence and the sophistication of the treatment available.

• The costs of lost production may be as much as five times the direct health care cost, according to estimates derived from 25 Latin American countries.

Recent studies in China, Canada, USA and several European countries have shown that feasible lifestyle interventions can prevent the onset of diabetes in people at high risk. 2.1 Statement of the Problem: What are the Psychosocial Predictors of Diabetes Clients?

2.2 Null Hypothesis: Patients who do not benefit from education are more likely to have psychiatric problems or particularly

ineffective coping styles. 2.3. Aims of the study: The aim of this study will be to determine which psychosocial factors directly and immediately influence patients' ability to learn diabetic self-care and decrease the level of depression, anxiety and stress. It will also improve the quality of life.

2.4 Objectives of the study:

1. Find out the psychosocial factors which influence patients’ ability to learn diabetes care. 2. Conduct education programme on the management of diabetes and minimization of the

psychosocial problems. 3. Evaluate the effectiveness of education intervention programme on management of diabetes.

2.5 Rational of the study: Diabetes mellitus (DM) is a major non-communicable disease affecting approximately 150 million people in world in 2002,180 million in 2003 and expected to reach 330 million in 2025. The prevalence of DM is steadily increasing world wide, particularly in developing countries. It is projected to increase by 170%, out of which 76% will be from developing countries2.

A study conducted by mehta3 in BPKIHS from 1-3-2003 to 29-2-2004 i.e. for 1 year among admitted diagnosed cases of DM found that, about 60.7 % subject had hypertension, 39.3 % had ocular problem, and 25 % had renal problems. Majority of subject (82.1 %) knows about the disease (DM) they were suffering but limited subject had the knowledge about, causes, curability, treatment modalities, diet, and other aspects. As the knowledge regarding various aspects of DM is very low, there is need for informational booklet in Nepali and health education programme among public will be very useful. Very few booklets are available in Nepal in Nepali on diabetes. As the number of diabetes cases is increasing very high and there is inadq2uate knowledge among the clients and their relatives to take care of client and prevent complications it is urgency to publish s booklet on Nepali for those clients. Hence, the investigators decided to conduct study on or Effectiveness of information booklet on diabetes among the admitted diabetes client in BPKIHS.

Psychosocial factors can play an important role in diabetes care. For example, patients often feel high levels of diabetes-related emotional distress, resulting in diabetes care "burnout". Depression is approximately twice as high among people with diabetes compared with those without chronic disease, and >40% of patients have been identified as depressed in some studies. Depression can interfere with self-care and glycemic control and is associated with increased morbidity, morality, and functional limitations as well as health care costs.

Patients who experience emotional distress often want more emotional support than they receive. Despite high levels of distress, relatively small numbers of patients receive psychological treatment. Primary care providers do not identify all those in need of psychological treatment, and those identified do not necessarily receive appropriate treatment. This is unfortunate because research indicates that psychological treatment in primary care can be effective. Moreover, treatment by psychosocial

specialists can be effective for patients who are referred for care. For example, recent meta-analyses indicate that mental health treatment is associated with reductions in depression and HbA1c levels. Medications represent another effective method of treatment.

Health care provider strategies for dealing with the psychosocial needs of patients with diabetes are not well understood. The research cited here indicates that psychosocial factors are important influences on diabetes outcomes, and subjective quality of life is a worthwhile outcome in its own right. Therefore, it is important to understand how health care providers deal with their patients’ psychosocial needs.

2.6. Implications of the study:

Nurses and diabetes specialists used psychosocial strategies more than physicians and nonspecialists. Psychosocial strategies were used more when practitioners believed that more patients

had psychosocial problems and that these problems interfered more with diabetes control. Referral to psychosocial specialists was significantly more likely when practitioners perceived that professional psychological resources were more available.

This research has examined two strategies for managing the psychosocial needs of patients with diabetes. Both of these strategies have a place in the repertoire of the diabetes care provider. All

patients are entitled to be treated by a provider who is sensitive to their psychosocial needs, and all providers should receive the training necessary to attain the appropriate level of expertise.

Yet, it is unreasonable to expect every diabetes care provider to be able to meet all of his/her patients’ psychosocial needs, just as it is unreasonable to meet all other specialized care needs. For physicians, referral to nurses, who tend to provide greater levels of psychosocial support, may be an option. But sometimes this option may not be enough, a fact that has resulted in the demand for increased involvement of psychosocial specialists in diabetes care . In an ideal practice environment,

psychosocial specialists are available on a routine basis as members of the diabetes care team. This permits the integration of psychosocial issues into regular multidisciplinary care. Research has shown that consultations between primary care providers and psychosocial specialists can improve patient outcomes and primary care provider satisfaction. Patients of nurses who monitor psychological status and incorporate these factors into their care planning have better psychosocial outcomes. And diabetes education incorporating coping skills training produced improved clinical and psychosocial functioning. But when psychosocial specialists are not part of the multidisciplinary team, it is even more important that providers have available a psychosocial specialist to whom patients can be referred when necessary.

The availability of psychosocial specialists was positively related to physician and nurse referral patterns, net of the perceived prevalence and severity of the problems for which patients are referred, and the referring provider’s own skills for managing psychosocial problems. This suggests that

increased availability of psychosocial specialists might increase their use. Other related issues, not addressed in this study, are whether the available psychosocial specialists are seen as competent to deal specifically with diabetes and whether providers’ perceptions of the competence of psychosocial

specialists play a role in their referral decisions.

2.7 Limitations of the study: The study will be conducted at BP Koirala Institute of Health Sciences only. 3. Review of Literature: Diabetes is a chronic disease that requires a lifetime of consistent and careful daily self-management. Failure to adhere to strict self-care regimens may lead over time to diabetic complications, such as retinopathy, nephropathy, neuropathy, and coronary heart disease.1,2 The role of psychosocial factors in the long-term outcome of diabetes patients has been widely studied and well documented.3–17 Previous studies have addressed a wide range of psychosocial factors at the personal, social, and community level, including the presence of psychiatric conditions3 (especially

depression4,5), health beliefs and attitudes,6–8 stress and coping styles,9–11 social support,12–14 and family and social environment.15–17 Education has been considered an important part of diabetic treatment. Education has been generally effective in increasing patients' knowledge about the disease, but it has not been as effective in changing self-care behavior.18 The research literature has shown that short-term and information-based educational programs are often ineffective in enhancing and sustaining treatment adherence, as the behavior of recipients of such programs deteriorates over time.19 A few studies have addressed the question of who benefits from diabetes education by examining the relationship between psychological factors and the effects of education. Wooldridge and associates7

conducted a 12-month follow-up after a diabetes education program that included patients with both type 1 and type 2 diabetes. They found no significant correlation between health beliefs and hemoglobin AIc (HbAIc) (the major fraction of glycosylated hemoglobin) values (a measure of glycemic control) or between self-reported compliance and HbAIc values. Rubin et al.,20 on the other hand, followed both type 1 and type 2 diabetes patients for 6 months and found that those with low levels of emotional well-being, poor self-care patterns, or poor glycemic control benefited the most from educational programs. In a 3-year follow-up study, Bott et al.21 found that the following factors were significant predictors of glycemic control: HbAIc values before the educational intervention, smoking, diabetes-related knowledge, blood glucose monitoring in the home, age at onset of diabetes, perceived

coping abilities, and insulin C-peptide levels. Their study, however, was limited to type 1 diabetes patients who participated in intensive treatment and teaching programs. O'Connor and his research team22 found that patients who had diabetes for 2 years or less and who had poor baseline glycemic control (HbAIc values greater than 10%) were more likely to have significant positive change in the glycemic index in response to educational programs. Their follow-up study, however, was based on HbAIc values obtained 2 months after the educational intervention, which reflect only the acute effects of outpatient education. The study did not investigate whether the educational program helped patients

to maintain good glycemic control over longer periods. We have observed clinically that some patients have trouble assimilating what they are taught in educational programs. In addition, other patients seem to assume responsibility for their self-care with relative ease in the beginning of treatment but fail in the long run. A meta-analysis of the effect of self-management education for adults with type 2 diabetes23 showed that the net changes in glycosylated hemoglobin values at the 1–3 month follow-up were particularly diverse. The authors noted that this finding may be partly explained by patient factors, such as psychosocial mediators. Also, Glasgow and Eakin24 stated that patients who require particularly intensive intervention may include those with major psychological disorders, such as clinical depression. On the other hand, Glasgow25 also emphasized

the role of social environment factors in diabetes self-management. The cost of diabetes: As the number of people with diabetes grows worldwide, the disease takes an ever-increasing proportion of national health care budgets. Without primary prevention, the diabetes epidemic will continue to grow. Even worse, diabetes is projected to become one of the world’s main disablers and killers within the next twenty-five years. Immediate action is needed to stem the tide of diabetes and to introduce cost-effective treatment strategies to reverse this trend4.

The size of the problem: A diabetes epidemic is underway. An estimated 30 million people would-wide had diabetes in 1985. By 1995, this number had shot up to 135 million. The latest WHO estimate (for the number of people with diabetes, world-wide, in2000) is 177 million. This will increase to at least 300 million by 2025. The number of deaths attributed to diabetes was previously estimated at just over 800,000. However, it has long been known that the number of deaths related to diabetes is considerably underestimated. A more plausible figure is likely to be around 4 million deaths per year related to the presence of the disorder. This is about 9% of the global total. Many of these diabetes related deaths are from cardiovascular complications. Most of them are premature deaths when the people concerned are economically contributing to society. This situation is increasingly outstretching the health-care resources devoted to diabetes 4. For WHO and the International Diabetes Federation (IDF), sponsors of World Diabetes Day, this increase can and must be prevented with the right measures.

The burden of diabetes and its complications: The exact costs of diabetes are not easy to pin down but estimations can be obtained according to three levels:

1. Cost directly related to the diagnosis and management of diabetes without complications. This includes the in-patient and out-patient care, means of treatment by insulin or tablets and the equipment of self control (blood and urine testing).

2. Costs generated by complications of diabetes. These are difficult to quantify because diabetes is linked to micro and macro vascular diseases such as heart disease, kidney failure, eye disease and amputation. Moreover, diabetes may add a cost of care by complicating other unrelated medical situations like infections, accidents and surgery.

3. Indirect costs correlated to the quality of life and the economic productivity which can be somehow estimated by the degree of disability.

Prevention of diabetes: Effective prevention also means more cost-effective healthcare. This may be the prevention of the onset of diabetes itself (primary prevention) or the prevention of its immediate and longer-term consequences (secondary prevention). Primary prevention protects susceptible individuals from developing diabetes. It has an impact by reducing or delaying both the need for diabetes care and the need to treat diabetes complications. Reliable examples of this measure come from studies undertaken among susceptible groups in China. Lifestyle modifications (appropriate diet and increased physical activity and a consequent reduction of weight), supported by a continuous education programme, were used to achieve a reduction of almost two-thirds in the progression to diabetes over a six-year period. This type of measure is not easy, but is likely to be cost effective if it can be implemented on a population scale. It should be considered particularly in the poorest regions of the world where resources are severely limited. Similar results have also been achieved recently in Finland and the USA. Such preventive measures will have benefits above and beyond diabetes since improvements in diet and day-to-day physical activity will reduce obesity, cardiovascular disease and some cancers. Secondary prevention includes early detection, prevention and treatment. Appropriate action taken at the right time is beneficial in terms of quality of life, and is cost-effective, especially if it can prevent hospital admission. Secondary prevention Measures:

• The treatment of high blood pressure and raised blood lipids, as well as the control of blood glucose levels, can substantially reduce the risk of developing complications and slow their progression in all types of diabetes.

• Another cost-saving strategy is the prevention of foot ulceration and amputation. Effective foot-care reduces both the frequency and length of hospital stays and the incidence of amputation in diabetes patients by as much as 50%.

• Screening and early treatment for retinopathy is also very cost-effective, given the devastating direct, indirect and intangible costs of blindness.

• Screening for protein in urine i8s another valid preventive measure to prevent or slow down the inevitable progression to kidney failure. Furthermore, there is evidence that screening for traces of protein is cost saving, as it allows even earlier intervention in the natural course of kidney disease.

• Measures to reduce the consumption of tobacco will also assist in the management of diabetes. Cigarette smoking has been found to be associated with poor control of blood glucose and it is also strongly causally related to hypertension and heart disease in people with diabetes as well as those without.

Complications associated with diabetes mellitus: Diabetes mellitus is a chronic disease caused by inherited and /or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. Such a deficiency results in increased concentrations of glucose in the blood, which in turn damage many of the body’s systems, in particular the blood vessels and nerves.

Diabetic retinopathy is a leading cause of blindness and visual disability. Diabetes mellitus is associated with damage to the small blood vessels in the retina, resulting in loss of vision. Findings, consistent from study to study, make it possible to suggest that, after 15 years of diabetes, approximately 2% of people become blind, while about 10% develop severe visual handicap. Loss of vision due to certain types of glaucoma and cataract may also be more common in people with diabetes than in those without the disease. Good metabolic control can delay the onset and progression of diabetic retinopathy. Loss of vision and blindness in persons with diabetes can be prevented by early detection and treatment of vision-threatening retinopathy: regular eye examinations and timely intervention with laser treatment, or through surgery in cases of advanced retinopathy. There is evidence that, even in developed countries, a large proportion of those in need is not receiving such care due to lack of public and professional awareness, as well as an absence of treatment facilities. In developing countries, in many of which diabetes is now common, such care is inaccessible to the majority of th4e population. Kidney failure: Diabetes is among the leading causes of kidney failure, but its frequency varies between populations and is also related to the severity and duration of the disease. Several measures to slow down the progress of renal damage have been identified. They include control of high blood glucose, control of high blood pressure, and intervention with medication in the early stage of kidney damage, and restriction of dietary protein. Screening and early detection of diabetic kidney disease are an important means of prevention. Heart disease accounts for approximately 50% 0f all deaths among people with diabetes in industrialized countries. Risk factors for heart disease in people with diabetes include smoking, high blood pressure, high serum cholesterol and obesity. Diabetes negates the protection from heart disease which pre-menopausal women without diabetes experience. Recognition and management of these conditions may delay or prevent heart disease in people with diabetes. Diabetic neuropathy is probable the most common complication of diabetes. Studies suggest that up to 50% of people with diabetes are affected to some degree. Major risk factors of this condition are the level and duration of elevated blood glucose. Neuropathy can lead to sensory loss and damage to the limbs. It is also a major cause of impotence in diabetic men. Diabetic foot disease, due to changes in blood vessels and nerves, often leads to ulceration and subsequent limb amputation. It is one of the most costly complications of diabetes, especially in communities with inadequate footwear. It results from both vascular and neurological disease processes. Diabetes is the most common cause of no traumatic amputation of the lower limb, which may be prevented by regular inspection and good care of the foot. Diabetic neuropathy is a heterogeneous disorder that encompasses a wide range of abnormalities affecting proximal and distal peripheral sensory and motor nerves as well as the autonomic nervous systems. For these reasons, it has been difficult to obtain precise estimates of the true prevalence and reports vary from 10 to 90% in diabetic patients, depending on the criteria and methods used to define neuropathy. From patients attending a diabetes clinic 25% reported symptoms; 50% were found to have neuropathy after a simple clinical test such as the ankle jerk or vibration perception test; almost 90% tested positive to sophisticated tests of autonomic function or peripheral sensation 17. The need for more diabetes educators to serve the numbers of people with the disease is the first major challenge in our country. In urban areas, at least in some metros, up to 30-40% of people can be reached through a diabetes education facility. However, in rural or less developed communities, this number may drop to zero. People in rural areas may have to travel for hours or even days to access specialist services18. Diabetic neuropathy is a most common and troublesome complication of diabetes mellitus, leading to the greatest morbidity and mortality and resulting in a huge economic burden for diabetes care. It is the most common form of neuropathy in the developed countries of the world, accounts for more admission to hospital than all the other diabetes complications combined and is responsible for 50.75% of non-traumatic amputations. Diabetes neuropathy is a set of clinical syndromes that affect distinct regions of the nervous system, singly or combined, It can be silent and go undetected, while

exercising its ravages, or be present with clinical symptoms and signs that although non-specific and insidious with slow progression also minic those seen in many other diseases. It is, therefore, diagnosed by exclusion17. Diabetes self management training, the process of teaching individuals to manage their diabetes has been considered on important part of clinical management since 1930 s1. The goal of diabetes education is to optimize metabolic control, prevent acute and chronic complications, and optimize quality of life while keeping. Costs acceptable. A programme of patient information and education, as a primary tool of diabetes treatment, has been developed during the past 5 years, aiming to an effective self-management of diabetes. The program is patient oriented, with an essential psychological approach, based on a realistic language and following the concepts of a simple, or diabetes philosophy”. The diabetes is considered as a human condition, not necessarily a disease 5. A study conducted by piette 4 on, “Impact of automated calls with nurse follow-up on diabetes treatment out comes in a department of veterans affairs health care system: a randomized controlled trial”, mentioned, at 12 months, intervention patients reported more frequent glucose self-monitoring and foot inspections than patients recovery usual care and were more likely to be seen in podiatry and diabetes specialty clinics. Intervention patients also were more likely than control patients to have had a cholesterol test”. How do we prevent and treat diabetes: Primary prevention, healthy diet and regular physical activity, protects susceptible individuals. It has an impact by reducing or delaying both the need for diabetes care and the need to treat diabetes complications. It should be emphasized particularly in the poorest rations of the would where resources are severely limited. Reduction in weight and half an hour of walking each day reduced the incidence of diabetes by more than one half in overweight subjects with mild Impaired Glucose Tolerance (IGT). Because of its chronic nature, the severity of its complications and the means required to control them, diabetes is a costly disease, not only for affected individuals and their families, but also for the health systems. Studies in India estimate that, for a low-income Indian family with an adult with diabetes, as much as 25% of family income may be devoted to diabetes care. For families in the USA with a child who has diabetes, the corresponding figure is 10%. In WHO’s Western Pacific region a recent analysis of health care expenditure has shown that: 16% of hospital expenditure was for people with diabetes. In the Republic of the Marshall Islands, This figure was 25%. And 20% of “offshore expenditure” on health by Fiji was for diabete3s-related complications – instances where facilities for care were not available in Fiji, so patients had to travel elsewhere. These represent considerable sums for countries that can ill afford such massive expenditure on preventable conditions4. Diabetes education18: Education is not just a part of diabetes treatment; it is the treatment. The key aims of diabetes education are to change behavior and promote self-management. Diabetes education consists of providing tools and support to patients as they learn to manage their disease thereby creating self-confidence. Education and imparting knowledge to diabetic patients is a complicated process. Individuals affected by diabetes must learn self-management skills and make life style changes to effectively manage diabetes and avoid or delay the complications associated with this disorder. For these reasons, self-management education is corner stone of treatment for all people with diabetes. Diabetes education has had had somewhat impressive results in reducing the frequency of certain chronic diabetic complications in high-risks groups, notably foot ulceration and amputation. To deal with the great challenge of the global increase in diabetes prevalence, a diabetes education team has to intervene. A diabetes educator can provide support by encouraging patients to talk about their concerns or fears about diabetes. When the patient is diagnosed for the first time, the diabetes educator can actively teach the self-management skills and help them to live their life with diabetes.

4. Research Methodology: It will be Analytical cross sectional study conducted among the diabetes clients getting treatment in diabetes clinic and admitted clients in medical units of BP Koirala Institute of Health Sciences during the period of 2008 and 2009. Using purposive sampling technique about 300 clients’ clinically diagnosed diabetes (Type-I & Type- II) will be included in the study. The clients who give consent to participate in the study regularly will be only included. The standard tested tools on psychosocial analysis of stress and coping inventory, profile of mode status along with socio-demographic and knowledge profile on diabetes used in Nepali tested version to evaluate the facts. 4-5 focus group discussion will be also arranged before and after the education intervention to evaluate the programme. The tools will be prepared in Nepali and their validity and reliability will be established. Following tools will be used for data collection: 1. Self Prepared Identification and demographic profiles 2. Beck Depression Inventory-II to evaluate Depression level 3. State Anxiety Inventory to assess stress level 4. Quality of Life index Procedure for data collection: On the diabetes clinic day (Once/Week) in medical OPD diabetes clinic and once per week in medical wards (unit - I, II, III) admitted diagnosed diabetes clients after informed written consent. The baseline information on psychosocial problems and knowledge profile will be assessed and then education programme will be provided in small groups, using prepared protocol and audio visual aids along with the information booklet. The regular follow-up will be made continuously during the study period and progress will be monitored and evaluated. The collected data will be analyzed using SPSS- 10.5 and STATA software package and available other appropriate statistical methods. Subjects: The subjects will be the patients with a diagnosis of type 1 or type 2 diabetes getting treatment in diabetes clinic or admitted in medical units of BPKIHS The Inpatient Diabetes Education Program: The hospital's diabetes education program consists of lectures on the causes of diabetes, acute and chronic complications, treatment, diet, exercise, medication, and other aspects of self-management, including foot care. The lectures will be given by the hospital staff, including physicians, nurses, a dietitian, and a pharmacist. In this comprehensive

program, this covers most areas involved in diabetic self-management. After the lectures, patients are interviewed daily by a charge nurse to check their level of understanding, and the nurse provides complementary information and training if necessary. The techniques for self-monitoring of blood glucose and/or insulin injection are taught individually and supervised until each patient masters these skills. Measures: The psychosocial measures used in the study included the Stress and Coping Inventory,26,27 the Toronto Alexithymia Scale,28–30 the NEO Five-Factor Inventory,31,32 and the Profile of Mood States (POMS).33,34 All of the questionnaires had been translated and validated in Nepali. Statistical Analysis: The ultimate purpose of diabetic education is to enhance patients' ability to maintain good glycemic control over a long period of time, thus improving their quality of life. Length of time as the number of months before relapse, and we estimated the rate of relapse using inferential statistics. 6. Organization of the Study: (Time Schedule) SN Activities Duration/Time 1. Literature review and finalization of the project 3 Months 2. Pre-testing and finalization of tool 3 Months 3. Data collection and education intervention 2 Years 4. Analysis of Data 1 Months 5. Report writing and Submission 5 Months ………………………. 3 Year

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Tools of the study

INTERVIEW SCHEDULE:

A. IDENTIFICATION DATA.

UNIT/WARD/OPD: IP NO/ OPD NO: CODE NO:

1. Name of patients: - 2. Age/Sex: - 3. Religion: 4. Ethnic group: 5. Occupation: 3. Education level; 4. Permanent address: District: VDC/NP: Ward No: Phone no: 5. Marital status: M/UM/W/D/S 6. Diet: veg/non-veg/ egg veg. 7. Frequency of admission: 8. Duration of disease: 9. Unit diagnosis: 10. Types of DM: IDDM / NIDDM B. RISK FACTOR 11. Weight (kg): 12. Height (cm) 13. BP: 14. Yearly saving:

a. Deficit budget/loan b. No saving / balance c. < 5000Rs. d. 5000-25000 Rs. e. >250000RS

18. Economic status of patients? A. Poor b. medium c. high 19. Family history (sister/brother) of diabetes? A. Yes b. no 20. Parents with diabetes? A. Yes b. no 21. Female: (birth of large baby > 3.5 kg.) a. Yes b. no c. not sure 22. Oral contraceptives? (Female) a. yes b. no 23. Do you have following habits? Habits At Present In Past a. Tobaccos chewing a. yes b. no a. yes b. no b. Betel chewing a. yes b. no a. yes b. no c. Guttka chewing a. yes b. no a. yes b. no d. Smoking (bidi/ cigarette/ hukka etc.) a. Yes b. no a. yes b. no e. Alcohol consumption a. yes b. no a. yes b. no 24. Life style: a. Heavy physical worker (farmer/labour} a. Office worker c. Sedentary life style d. Others. 25. Obesity: a. yes b. no 26. History of stress (surgery/ trauma /others etc.) a. Yes b. no C ARE YOU ON FOLLOWING TREATMENTS/THERAPIES FOR DIABETES? TREATMENT/THERAPIES AT PRESENT IN PAST 27. Oral hypoglycemic agent (OHA): a. yes b. No a. Yes b. No 28. Insulin a. yes b. No a. Yes b. No

29. Diabetic Diet. a. Yes b. No a. Yes b. No 30. Weight loss therapy. a. Yes b. No a. Yes b. No 31. Quit smoking a. yes b. No a. Yes b. No 32. Herbal/traditional remedy a. yes b. No a. Yes b. No 33. Living situation

Own living

With relative

Group home

Missing

34. Relationship between the caregivers and the clients

Spouse

Parent

Child

Sibling

35. Frequency of occupation outside home

One to 5 days every week

Irregularly

36. Burden Assessment Scale (BAS)

Worried about what future holds for him/her

Disturbed household routine

Upset about patient change from former self

Difficulty concentrating on own activities

Cut down on leisure time

Worried that might make illness worse

Guilty because not doing enough to help

Less time with friends

Family friction and arguments

Had to change your personal plans

Neglected other family members' needs

Had financial problems

Stigma of illness upsetting

Felt trapped by care giving role

Embarrassed due to behaviour

Guilty: felt responsible for causing problem

Resentful because too many demands

Missed days at work or school

Friction with neighbours

BAS Total

37. Item: Would you tell me to what extent you have had any of the following experiences in the past 6 months

Factor I (activity limitation)

Factor II (feelings of worry and guilt)

Factor III (social strain)

Communality

Financial problems

Missed work/school

Difficulty concentrating

Change personal plans

Reduced leisure time

Upset household routine

Less time for friends

Neglected family's needs

Evaluation of the Education Programme on Diabetes: (Post test Only)

38. Have you studied this type of information booklet earliar? A. Yes b. No

39. Is this information booklet understandable?

a. Easily understandable b. Understandable with little difficulty c. Not understandable

40. Is the contents covered are appropriate?

a. Very appropriate b. Appropriate c. All right d. Not appropriate

41. Is this booklet useful / helpful to you? a. Very helpful b. All right c. Not useful

42. How you evaluate this booklet? (a) Very good (b) Good (c) All right (d) Poor

43. Do you recommend other people to read this booklet? A. Yes B. No C. Don’t know

THANKS FOR SUPPORT AND CO-OPERATION

Appendix - I

Summary of Patient and Physician Responsibilities in Intensive Diabetes Self-Management System

Patient Responsibilities: • Monitoring of blood glucose • Exercise program • Adherence to dietary guidelines • Blood pressure monitoring • Smoking cessation • Consistent use of aspirin • Overcoming psychologic and other barriers • Healthy expression of feelings • Foot and eye care • Understanding “targets” for control of blood glucose and blood pressure • Communication with physician and diabetes care team • Keeping appointments • Record keeping • Adherence to medication regimen • Evaluation of physician and diabetes care team • Treating and modifying “targets” in collaboration with physician • Knowledge of personal glycosylated hemoglobin value and its meaning Physician Responsibilities: • Adherence to the system of intensive self-management of diabetes • Measurement of outcomes • Determination of patient satisfaction • Maintenance of communication with team • Development of evaluation programs; include safety in taking medication and

identification of patient misconceptions • Listening to patient concerns • Establishing and maintaining follow-up schedule • Documentation of patient care • Supervision of the patient’s diabetes education • Encouragement of patient in use of preventive measures and risk reduction • Supervision of proper foot care procedures

Appendix: - II Topics to be addressed during the overall course of treatment of the

patient with diabetes

1. Path physiologic features of diabetes. 2. Rationale for the intensive treatment of diabetes mellitus

a. Potential complications associated with diabetes. b. Relationship between control and complications.

3. Self-monitoring of blood glucose. a. Use of blood glucose self-monitor. b. Schedule for use (minimum of twice daily) c. Instructions for record keeping.

4. Medication. a. Description b. Dosing instructions c. Dosage adjustment algorithms. d. Suggestions for record keeping.

5. Nutrition a. Importance b. Prescribed meal plan c. Dealing with nutrition-related fluctuations in blood glucose levels. d. Suggestions for record keeping.

6. Exercise. a. Importance b. Prescribed exercise plan c. Dealing with activity-related fluctuations in blood glucose levels. d. Suggestions for record keeping.

7. Recognizing and managing potentially dangerous complications. a. Hypoglycemia. b. Diabetic ketoacidosis. c. Hypoglycemia unawareness. d. Infection e. Vascular disease.

8. Instructions for special situations. a. Sick day rules. b. Travel instructions. c. Use of glucagons.

9. Preventive care. a. Foot care. b. Skin care.

10. Psychological aspects. a. Effect on relationships+ and family dynamics. b. Effect on self-image. c. Importance of support. d. Denial.

11. Instructions for family members.