"Outcome of Diabetes Education Among Renal Transplant Recipients With New Onset Diabetes After Transplantation (NODAT)"
Condition: New Onset Diabetes After Transplant; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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:

      This form will include patient's metabolic control variables such as HbA1c, lipids (Total
      cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL),
      renal and liver function tests. Metabolic control parameters will be measured in Hamed
      Al-Essa organ transplantation center (OTC) outpatient clinic and will be sent with each
      patient to Dasman Diabetes Institute within one week of patient evaluation for starting
      educational program.

      Blood pressure, height, weight, body mass index and waist circumference of patients will be
      measured and recorded by the researcher each time by using the same measurement device and
      method. Patients' waist circumferences will be measured midway between costal margin and
      iliac crests by a measuring tape in standing position, over underwear and after slight
      expiration.

      Diabetes self-care scale (DSCS) The Arabic translated 24-items scale- developed in English by
      Lee and Fisher(41) which measures the self care of patients with diabetes -will be applied to
      patients before and after the education program.

      Data collection method In the pretest phase of the research, patients will be given a patient
      identification form, metabolic control parameters form and a DSCS. The forms will be
      completed within15-25 minutes by the patients in the presence of the researcher. Telephone
      numbers and addresses of patients will be taken for proper communication if needed.

      Patient education Group education sessions will be carried out in special halls in Dasman
      Diabetes Institute (DDI) after proper coordination with the randomly selected patients (group
      1) (6-10 patients in each education group). Patients of one to one education group (group 2)
      will receive education sessions individually in closed education clinics of DDI. The first
      session will last for 60 minutes then the next sessions will last for 30 minutes. The content
      of education will be repeated entirely or partly by the researcher according to each
      patient's needs. Mixed education techniques such as description, question and answer
      techniques will be used as an education method and feedback will be stimulated trying to
      enable patients to understand their self-care management independently. Refreshment education
      sessions will be delivered every 3 months later on till the end of the study.

      Regarding patients of the third group (control group), each patient will receive the
      conventional (non-structured) education program in their mother hospital (OTC).
    

Intervention name(s): group education
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): one to one; conventional education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: renal; diabetes; outcome; transplant; Education