Non-compliance to treatment among type 2 diabetic men in Mosul : A case-control study

Context: Non-compliance to treatment among diabetic patients is a world-wide problem and its underlying risk factors can be the subject of many studies in different localities. Objective: To identify risk factors for non-compliance to treatment plan among type 2 diabetic men attending Al-Wafaa Center for diabetes in Mosul City. Methods: A case-control study design has been adopted. A special questionnaire form has been prepared and filled in by the investigator for each patient (case and control) through direct interview with patients. Results: Study results revealed a significant association between non-compliance and socioeconomic strata, duration of disease >10 years, number of tablets >2 daily, frequency of taking medication >2, poor patient satisfaction about health personnel, body mass index >30 and sedentary life style activities. On the other hand, an inverse association was found between non-compliance and urban place of residence, marriage, 1 and 2 school level of education, taking medical treatment without herbals and type A personality. Conclusion: The study concluded that health care professionals are in need to identify risky patients for non-compliance and recommends to use the counseling approach of communication before applying any individual patient management plan characteristics.

ype 2 diabetes is a complex metabolic disorder of heterogeneous etiology with social, behavioral, and environmental risk factors unmasking the effects of susceptibility. (1,2)It is the most common clinical form of diabetes worldwide; it accounts for about 90-95% of all cases of diabetes globally (3) .The disease is typically treated with diet regimen, life style changes and oral medication (1,2) .There is strong evidence that vigorous treatment can decrease morbidity and mortality by decreasing its chronic complications (4) .
Patient's non-compliance to treatment plan influences glycemic control (5) .A wide variety of studies demonstrate that patients who fail to adhere to the prescribed clinical regimens have very poor outcomes (6,7) .The likelihood of recurrent diabetic crises is related in part to patient non-compliance (6,8,9) .
In diabetes care, non-compliance may represent an important component of unnecessary health care cost, especially hospital costs.Thus the development of effective and efficient methods to assess the possible contributors to non -compliance in the out-patient setting appears very desirable (10,11) .
Non compliant type 2 diabetics refer to those patients who intentionally don't follow what they are told about their illness and they don't follow the recommendations including self management behaviors, changes in lifestyle and adherence to medication (12)(13)(14)(15) .In other words, non-compliant diabetics disobey the advice of their health care provider (16).The concept of non-compliance not only assumes a negative attitude toward patients, but also places patients in a passive unequal role in relationship to their care provider.Noncompliance is attributed to personal qualities of patients, such as forgetfulness, lack of will power or discipline, or low level of education (17) .0) Lower regimen adherence can be expected when a health condition is chronic, when the course of symptoms varies or when symptoms are not apparent, when a regimen is more complex, and when a treatment regimen requires lifestyle changes (21,22) .
Study aim is to identify risk factors for noncompliance to treatment plan among type 2 diabetic men in Mosul.

Subjects and Methods
To start with, and in regard to ethical issue, a seminar about the research protocol was conducted at the Department of Community Medicine.Also official permissions were obtained from Al-Wafaa Center for diabetes and Nineveh Health Directorate.Al-Wafaa Center for diabetes is the only specialized center in Mosul that deals with the management of diabetic patients.It offers services to all diabetics in Mosul city.It has been established in 1999.A written consent form has been prepared to be signed in by each patient agreed to be involved in the study.To achieve the aim of the present study a case control study design has been adopted.
Study subjects are 310 male patients with type 2 diabetes (150 cases and 160 controls) within the age ≥18 years.All were taken randomly from Al-Wafaa center attendants.Cases were considered as non compliant patient whose age was ≥18 years with type 2 diabetes for more than one year, and has at least three of the following inclusion criteria: 1. Doesn't follow a proper dietary regimen .2. Doesn't take medicine regularly.3. Doesn't adopt measures to control his bodyweight.4. Doesn't conduct regular physical activity.
While controls included compliant patients whose age was ≥18 years, with type 2 diabetes for more than one year, and has at least three of the following inclusion criteria including criterion number two: T 1. Follows proper dietary regimen.2. Takes medication regularly.3. Follows proper weight control measures.4. Adopts regular physical activity.
All the above mentioned inclusion criteria for cases and control have been put by the investigator and through a seminar which was conducted at Community Medicine Department .
Data collection tool was a special questionnaire form prepared by the investigator through utilizing the available related literatures and taking in consideration the idea of the specialized physicians at the Department of Community Medicine and Al-Wafaa Center for diabetes.All the questionnaire items were reviewed by community medicine teaching staff to consider its validity and reliability which were 85%.Economic status has been determined high, middle or low according to the type of occupation, presence or absence of private house ownership and car ownership.
Statistical analysis was done after tabulation of collected data; P value and odds ratio were calculated, looking for any statistical association between non compliance and other factors.

Results
Study results revealed that 42% of study population are within the age group 41-50 years, more than 80% of them are from urban regions, married and with 1 0 and 2 0 school education level.No significant difference was obtained between compliants and noncompliants in regard to age, marital status and level of education.However, a weak significant difference between compliants and noncompliants has been found for place of residence (p=0.048) while socio-economic strata was significantly differs (p=0.000).
Table 2 shows a significant association between non-compliance and duration of disease more than 10 years.A diabetic who has the disease since more than 10 years is almost twenty times not adherent to the treatment plan as shown from the significant values of p, odd ratio and 95% C.I. (p=0.000,OR=18.4,95%C.I. =10.28 -33.04) .
In regard to management plan characteristics, the results of the study reveals a highly significant, association between noncompliance and number of tablets >2 and daily frequency of drugs administration >2 with P value of 0.000 and OR of 21.5 and 31.2 respectively (Table 3).

Discussion
A case-control study design was adopted.The advantages of such design are better availability of cases, it needs less time and economically less expensive (23) .On the other hand, bias could occur in selection of cases and/or controls.In addition no actual causation can be proved; only associations between disease and risk factors of interest can be detected (24) .Regarding limitations of the present study, it was conducted upon patients attending Al-Wafaa Center for diabetes, the study subjects might not represent all diabetic patients in Mosul.About 81% of cases and controls were from the age groups above 30 years.Such result could be explained through the fact that type 2 diabetes is typically an adult onset disease.No significant difference was obtained between cases and controls in regard to age, marital status and level of education.Such result can reflect the proper selection of cases and controls.More than 80% of cases and controls were from urban places.Data from developing countries show that diabetes is more prevalent among urban population.Urbanization and high socio economic status are associated with the development of diabetes in susceptible people as they adopt western life style behavior which includes consumption of unhealthy diet (25) .
Around 80% of study population were within the educational level of 1 o and 2 0 school.Such result can express the level of education among such group in Mosul population (25) .From other point of view, (> 10 years) duration of disease was found to carry higher levels of non-compliance.Similar to the findings of a study conducted in Canada: 62% of people with diabetes for ≥ 15 years were non-compliant (26) .
In regard to management plan characteristics, highly significant association was found with (> 2 number of tablets) and frequency of administration.Perhaps forgetfulness in taking drug is the problem.As the number of pills increases and number of times pills must be taken each day rises, compliance fails (27) .Patients who took the drug once a day did a much better job at sticking with their plan.They took correct number of doses on more days, and they miss doses often, less than those taking the drug twice aday.Drugs taken once a-day may have important advantages over drugs taken twice a-day in treatment of type 2 diabetes (25,28) .A significant result was found between noncompliance and poor patient satisfaction about health personnel.Making patient satisfied with health personnel is one of the key elements to success in achieving good glycemic control (12,22,29) .Negative view of patients toward their doctor and poor provider communication have lower compliance rates to oral medications and self monitoring of blood glucose (33) .The present study revealed that 84% of cases have BMI >30 against 20.6% of controls.Such high rate of obesity among non compliant patients goes with the finding of AL-Chetachi (31) study which demonstrated that 88.3% of diabetic patients were over weight and obese.Similar finding was documented by Fadhil et al (32) in 2003.
Study results revealed that 78% of cases had sedentary life style activities against only 18.8% of controls.Such result goes with the findings of several studies (25,32,33) .Exercise is an important component in the management of diabetes.The amount of regular physical activity plays an important role in maintaining a healthy body weight, and lowering the risk of diabetes (34,35,36) .

Conclusion
Identification of risk factors to non-compliance to treatment is essential, prior to applying any treatment method for diabetic patients in order to overcome the problem of non-compliance.

Recommendations
Risky diabetic patients for non-compliance need to be identified initially before applying any method of management.
In dealing with diabetic patients, physicians have to choose, when possible, the simplest plan characteristics in regard to number of tablets and daily frequency of administration.
For better patient satisfaction, health care professionals are in need to use the counseling approach of communication with diabetic patients rather than the traditionally used consultation approach.Utilizing the mass media for diabetes related health educational programs can improve patient's knowledge and attitude towards higher compliance rates.

Table ( 4
): Association between health status variables and non-compliance.