"Outcome of Diabetes Education Among Renal Transplant Recipients With New Onset Diabetes After Transplantation (NODAT)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation .
研究概览
简要总结
Introduction:
Diabetes is a chronic disease that requires lifelong self care behavior. Successful treatment of chronic diseases is closely associated with the education of both patients and their relatives. Patient education is one of the most important responsibilities of diabetes nurse educators. In the management of diabetes, helping patients to improve their health and quality of life is considered an important aspect of diabetes self-care education. Solid organ transplantation is now the standard of care for end-stage organ failure. New-onset diabetes mellitus after solid organ transplantation (NODAT) has emerged as an increasingly important determinant of outcomes and survival in transplant recipients. Patient education and self-management are crucial for ensuring successful outcome post transplantation. No adequate studies concerning education of diabetic renal transplants.
Aim of the work: The aim of this work is to evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation (NODAT) on their self-care activities and metabolic control variables and reversibility of the present chronic diabetic complications.
Patients and methods:
The study will involve 210 diabetic renal transplant patients (NODAT) who will be referred from Hamed Al-Essa organ transplant center to Dasman Diabetes Institute. These patients will be sub-divided into three subgroups: patients who will receive group education (n=70) will represent group1, patients who will receive one to one education (n=70) will represent group 2, while those who will receive the conventional (not structured) education program will serve as control group 3(n= 70). All patients of group 1 and 2 will receive intensive education for 3-4 months, then refreshment session every 3 months for 2 years. Initially, patient data will be collected through 3 types of forms: patient identification form, metabolic control parameters form and diabetes self-care scale questionnaire; then every 6 months metabolic parameters and diabetes self-care scale questionnaire will be reassessed.
Expected outcome: Patient education given to transplant recipients with NODAT could affect patients' self-care activities, metabolic control positively and possibly help in reversal of chronic diabetic complications
详细描述
The research population will include organ transplant recipients with NODAT who are followed up in Hamed AL-Essa organ transplant centre of Kuwait and who will meet the eligibility criteria. Two hundred and ten diabetic renal transplant recipients will be enrolled in this prospective randomised controlled study. Patients who fulfil the following criteria will be included in the study: 1) transplant duration more than 6 months; 2) being an outpatient; 3) not having any psychiatric history of illness; 4) written consent to participate in the research; and 5) age of diabetic patients more than 21 years . We will exclude paediatrics (bellow 21 years) and mentally abnormal patients. Ethical principles of the research Written permission will be received from the institutions where the research will be carried out. Information form including the aim and scope of the research will be submitted to Ethical Committees of both ministry of health (MOH) of Kuwait and Dasman Diabetes Institute.
Data collection tools
Patient identification form:
This form will include information about the patient's identifying characteristics such as age, gender, education status and disease-related information such as duration of the disease and the treatments management of diabetes.
Metabolic control parameters form:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transplant duration more than 6 months; 2) being an outpatient; 3) not having any psychiatric history of illness; 4) written consent to participate in the research; and 5) age of diabetic patients more than 21 years
排除标准
- •pediatrics (bellow 21years) and mentally abnormal patients.
结局指标
主要结局
Evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation .
时间窗: For 2 years from the time of enrolment
Positive metabolic control and self-care diabetes management
次要结局
- comparison of type of diabetes education(For 2 years from the enrolment)
研究者
Nashwa Othman
Senior specialist diabetes educator
Dasman Diabetes Institute