Adherence and Beliefs About Medications, and Illness Perception Among Type 2 Diabetic Patients in Assiut University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- The third part of the questionnaire is the Arabic version of Morisky Medication Adherence Scale (MMAS-8)
研究概览
简要总结
Diabetes mellitus (DM) is considered one of the oldest fast-growing publichealth problems. It's a chronic metabolic disorder characterized mainly by highlevel of glucose level, associated globally with increased morbidity andmortality particularly in developing countries [1].DM leads to serious problems in heart, blood vessels, kidney and nerves.The World Health Organization (WHO) had anticipated that DM is going tobecome the seventh most significant primary cause of death worldwide by theyear 2030 [2]
详细描述
Diabetes mellitus (DM) is considered one of the oldest fast-growing public health problems. It's a chronic metabolic disorder characterized mainly by high level of glucose level, associated globally with increased morbidity and mortality particularly in developing countries [1].
DM leads to serious problems in heart, blood vessels, kidney and nerves. The World Health Organization (WHO) had anticipated that DM is going to become the seventh most significant primary cause of death worldwide by the year 2030 [2].
Main types of DM include type1 DM where the body stops making insulin, and type 2 DM which is more common, usually in adults when the body becomes resistant to insulin or doesn't make enough insulin [3].
Currently, 463 million persons suffer from diabetes worldwide. In addition, 55 million in Middle East and North Africa (MENA) Region suffer from diabetes, and it is estimated that by 2045 this will rise to 108 million according to the International Diabetes Federation (IDF) [4] Egypt is considered the ninth leading country in the world for the number of type 2 diabetes patients and its prevalence was nearly tripled over the last 2 decades, reaching 15.2% as nearly 8 million of adults suffer from type 2 DM, expecting to be doubled by 2045, urging the global community to recognize DM as one of the most important health challenges of the twenty first century [4].
Hence comes the importance of self-management in patients with type 2 DM in reducing complications from the disease and improving overall health outcomes. These important self-management behaviors include taking medications regularly, healthy diet, doing physical activities, quitting smoking, foot care and self-monitoring blood glucose level [5].
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Patients who are diagnosed with type 2 DM for at least 1 year according to the diagnostic criteria of the 10th revision of the International Classification of Diseases (ICD-10).
- •2- Patients treated with insulin or oral medication or both for at least 6 months.
- •3- Age group: adult patients (> 18 years old) will be included in the present study.
排除标准
- •1- Newly diagnosed diabetic patients or ill on the day of recruitment, or not taking any medications for type2 DM 2- Patients with type1 DM 3- Psychiatric patients or on anti-depressant treatment or using psychotropic drugs affecting their cognitive ability.
结局指标
主要结局
The third part of the questionnaire is the Arabic version of Morisky Medication Adherence Scale (MMAS-8)
时间窗: 2 years
It remains one of the most widely used mechanisms to assess patient adherence . It consists of 8 questions. Response choices are "yes" or "no" for items 1 through 7 and Item 8 has a five-point Likert response scale. Each "no" response is rated as 1 and each "yes" response is rated as 0 except for item 5, in which each "yes" response is rated as 1 and each "no" response is rated as 0. For Item 8, the code (0-4) must be standardized by dividing the result by 4 to calculate a summated score . Total scores on the MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and \<6 reflecting low adherence
The fourth part of the questionnaire is the Brief Illness Perception Questionnaire (B-IPQ).
时间窗: 2 years
B-IPQ is a rapid assessment tool with a Cronbach's alpha of 0.65 that measures eight different aspects of illness perception: consequences, timeline, personal control, treatment control, identity, concerns, understanding, and emotional representation \[15\]. The B-IPQ is a 9-item instrument that measures illness perception from eight different aspects using an 11-point Likert scale. A higher score reflects a more threatening view of the illness, while a lower score indicates a benign view of the illness
through semi-structured questionnaires which will be filled by the researcher herself. The questionnaire will be composed of five parts:
时间窗: 2 years
The first part will inquire about sociodemographic data such as age, sex, educational level, occupation, residence, and marital status.
The second part is about clinical data
时间窗: 2 years
The second part is about clinical data including BMI, duration of diabetes, type and number of prescribed medications, number of comorbid conditions, number of diabetes-related complications, and patients' most recent HbA1c levels were taken from medical records. HbA1c levels of ≥ 8% indicate suboptimal glycemic control in patients with T2D.
The fifth part of the questionnaire is the Beliefs about medicine which is assessed using the Arabic version of the Beliefs about Medicines Questionnaire Specific (BMQ-Specific).
时间窗: 2 years
It includes two subscales, which evaluate patients' perceptions of the necessity of medicine in controlling their illness (Necessity-Specific) and concerns about potential adverse effects of medicine (Concerns-Specific). Each subscale consists of 5 items and is scored on a 5-point Likert scale. High scores on the Necessity-Specific subscale indicate that the patient perceives their medicine as necessary, whereas high scores on the Concerns-Specific subscale indicate that the patient is concerned about potential adverse effects
次要结局
未报告次要终点
研究者
Zeinab Galal Eldeen Abdelhamid
Principal Investigator
Assiut University