الفهرس 
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Abstract
Summary
Diabetes Mellitus is one of the widespread and universal health problems that affect many people worldwide. Such disease describes as a metabolic disorder of multiple etiology characterized by hyperglycemia associated with alterations in carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action, or both. Diabetes may be present with characteristic symptoms such as thirst, polyuria, blurring of vision, and weight loss. The effects of DM include long–term damage, dysfunction and failure of various organs. In most severe forms of DM, ketoacidosis or a non–ketotic hyperosmolar state may develop and lead to stupor, coma and death in absence of effective treatment, (Dilworth et al., 2021).
Compliance to therapeutic regimen including, physical activity, diet, checking and controlling the blood glucose level is a strategic effort to reduce the risk of advanced complications among diabetic patients as well as to improve their clinical outcomes. In long-term management, the importance for the diabetic patients to actively participate in health education programs, diet planning, physical activity and insulin-drugs. Many researches had shown that patients with good compliance behavior had a lower risk of complications and a higher quality of life (Pratiwi et al., 2022).
Aim of the study:
This study aimed to assess the relation between therapeutic regimen compliance and clinical outcomes among the patients with diabetes mellitus through the following:
1. Assess compliance level of the patients with diabetes mellitus toward therapeutic regimen.
2. Assess clinical outcomes for the patients with diabetes mellitus.
3. Assess the relation between therapeutic regimen compliance level and clinical outcomes among the patients with diabetes mellitus.
4. Assess the correlation between patients’ therapeutic regimen compliance level, clinical outcomes and other factors (patients’ -demographic characteristics, medical data and knowledge).
Research questions:
The study was conducted to answer the following research questions:
1. What is therapeutic regimen compliance level of the patients with diabetes mellitus?
2. What are the clinical outcomes for the patients with diabetes mellitus?
3. Is there a relation between therapeutic regimen compliance level and clinical outcomes among the patients with diabetes mellitus?
4. Is there a correlation between patients’ therapeutic regimen compliance level, clinical outcomes and other factors (patient’s demographic characteristics, medical data and knowledge)?
Research design:
A descriptive exploratory design was conducted to achieve the aim of this study. The used design is defined as a description of new situations, events, or concepts, examine relationships among variables, it is concerned with description of a phenomenon of interest and focuses on a single group or population characteristics without trying to make interference (Grove & Gray, 2019).
Setting:
This study was conducted in the diabetes and endocrine outpatient clinic located in the 1st floor- at El Haram Hospital Giza, Egypt. In addition, this hospital consisted of four floors with different specialties. The study setting was selected because it is affiliated to Ministry of Health and provides medical services for 3 governorates (Giza, Fayoum and 6 October).
Subjects:
A convenient sample of adult patients with diabetes mellitus from both genders, and who agreed to participate in this study. By using power analysis equation, the study subject’s size was 380 patients. They were a representative of total patients attended to diabetes and endocrine clinic (N=22867) at El Haram hospital.
Tools of data collection:
Tool (I): Patients interview questionnaire:
It was developed by the researcher based on recent literature review (Taha,et al., 2011 & Ahmed & Abd-El Mohsen, 2018) and it was divided into 3 parts as follows:
• Part 1: It was used to assess the studied patients’ demographic data that included name, age, gender, residence, education, marital status, and employment.
• Part 2: It was used to assess the studied patients’ medical data that included diagnosis, health history, duration of illness, patient’s complains, and treatment.
• Part 3: Knowledge assessment questionnaire: It was used to assess the studied patients’ knowledge about diabetes mellitus such as types, causes, signs, symptoms, risk factors, complications, lab investigations, and therapeutic regimen. Scoring system was given one grade for correct answer and zero for incorrect answer, so total score was classified as the following:
- ≥ 80% was considered satisfactory knowledge
- < 80 % was considered unsatisfactory knowledge.
Tool (II): The studied patients’ compliance assessment tool:
It was developed by the researcher based on recent and relevant literature (Taha, 2011 & Lewis, 2016). It was used to assess the studied patients’ compliance toward therapeutic regimen related (diet, exercise, blood sugar testing, medication, and foot care). It was measured according to 5 likert scale as the following:
Always = 5, often = 4, sometimes = 3, rarely = 2, never = 1
The patients’ response for each item as always or often was considered compliance, while their responses as sometimes, rarely or never were considered non-compliance. So that the total score was classified as follows:
- ≥ 80 % is considered compliant.
- < 80 % is considered non-compliant.
Tool (III): The studied patients’ clinical outcomes assessment Form: It was used to collect the objective data about the outcomes of patients with diabetes mellitus; it included the following two parts:
• Part 1: Foot assessment sheet: This part used to assess the studied patients’ foot by using (INLOW’S 60-second Diabetic Foot Screen), it is a screening tool adopted from Orsted et al., (2017). It was used to assess the patients’ left & right foot regarding the following parameters: color, temperature, sensation, pulse, and motion, and others for preventing or treating diabetes mellitus foot ulcer and/or limb-threatening complications. The appropriate score was stated for each parameter. So the response to each item was two options either yes /present was given one grade or no/ absent was given zero.
• Part 2: Laboratory Investigations: This part was used to collect data about the results of blood glucose level such as, Fasting Blood Sugar (FBS), Post Prandial Blood Sugar (PPBS), and Hemoglobin A1C test (HbA1c), which collected from the patients’ file.
Scoring system:
Scoring system: total score ranged from 0 – 6 score and classified into the following:
- Good outcome < 50% = < 15 score
- Average outcome 80% - 50% = 5 –15 score
- Poor outcome > 80% = > 5 score
Total patient clinical outcome score ranged from 0 – 31score and classified as the following:
- Good outcome < 50% = <15 score
- Average outcome 80% - 50% = 24 – 15 score
- Poor outcome > 80% = > 24 -31 score
The result of the current study can be summarized as the following:
• Concerning the studied patients’ demographic data; 25.5% of them aged more than 50 years old, 65.8% of them were males, and 71.1% were living in urban areas. Regarding the level of education, 34.5% of the studied patients had secondary education, 81.6% of them were married, and 60.5% of them were employed.
• Regarding the studied patients’ present medical history; 57.9% of them were suffering from T2DM, 48.2% of them the duration of their illness was more than ten years ago. Also, 72.6% of them were measuring their blood glucose level daily, 43.7% of them were checking their HbA1c every six months, and 60.5% of them were taking insulin as a treatment.
• As regards the studied patients’ past medical history; 59.2% of them had another health problems, as 22.2%, 9.3%, 17.8%, and 8.0% respectively of them were suffering from hypertension, pneumonia, numbness, and blurring of vision respectively, and 100.0% of them were receiving a medical treatment for these problems. Also, slightly 50.8% of the studied patients had a history of previous surgery. In addition to 70.0% of them had a family history of diabetes mellitus, and 58.3% of them had first degree relatives with DM.
• Regarding the studied patients’ knowledge regarding DM; 39.2% of them had satisfactory total score, while 60.8% of them had unsatisfactory total score of knowledge.
• Concerning the studied patients’ compliance towards therapeutic regimen; 34.2% of them were compliant towards the therapeutic regimen, while less than two thirds 65.8% of them were non-compliant to the therapeutic regimen.
• As for the studied patients’ clinical outcomes; 52.6% of them had a good total clinical outcome score, while less than one fourth 24.0%, and 23.4% of them had average and poor total clinical outcomes scores respectively.
• Additionally, there were highly statistically significant positive correlations between the studied patients’ total scores of knowledge, compliance, and clinical outcomes score (p<0.001).
Conclusion:
In the light of the present study findings, the following can be concluded:-
More than one third of the studied patients were compliant towards the therapeutic regimen, while less than two thirds of them were non-compliant to the therapeutic regimen. Moreover, more than half of them had a good total clinical outcome, while less than half of them had average and poor total clinical outcome. Additionally, there were highly statistically significant positive correlations between the studied patients’ total scores of knowledge, compliance, and clinical outcomes.
Recommendations:
Based on the present study findings, the following recommendations are suggested:
• Designing and implementing health education programs intervention should be performed in order to improve the studied patients’ knowledge, and reported practices regarding diabetes mellitus management and evaluate its effect on their compliance level toward therapeutic regimen.
• Implementation of intensified follow up multidisciplinary intervention approaches should be performed in order to maximize the diabetic patients’ degree of compliance towards the therapeutic regimen and its positive effect on their clinical outcomes.
• Printed Arabic booklet should be available and distributed among the diabetic patients for urging them about the importance of compliance towards therapeutic regimen.
Further researches:
• Further studies are required to determine the main factors which lead to non- compliance of the diabetic patients towards therapeutic regimen.
• Longitudinal study should be designed to determine the long term needs of diabetic patients over a long period of time to enhance their compliance toward therapeutic regimen and subsequent clinical outcomes.
• Replication of this study is necessary using a large sample size selected from different geographical areas in Egypt in order to generalize the results.