"Outcome of Diabetes Education Among Renal Transplant Recipients With New Onset Diabetes After Transplantation (NODAT)"

NCT04030013 | Completed DMC

• 1 other identifier: RA 2014-049
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

New Onset Diabetes After Transplant; Diabetes Mellitus

Keywords

renal; diabetes; outcome; transplant; Education

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation .

  Positive metabolic control and self-care diabetes management

  For 2 years from the time of enrolment

Secondary Outcomes (1)

• comparison of type of diabetes education

  For 2 years from the enrolment

Study Arms (3)

Group education for 2 years

ACTIVE COMPARATOR

Patients who will receive structured diabetes education in groups , Group 1

Other: group education

One to one education for 2 years

ACTIVE COMPARATOR

Patients who will receive one to one structured diabetes education, Group 2

Other: group education

Control group without structured education

NO INTERVENTION

Patients who will not receive structured diabetes education, Group 3

Interventions

group education OTHER

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.

Also known as: one to one, conventional education

Group education for 2 years; One to one education for 2 years

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• pediatrics (bellow 21years) and mentally abnormal patients.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman diabetes institute

Kuwait City, Kuwait City, 15462, Kuwait

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nashwa F Othman, MD PhD

  Senior diabetes educator in Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Osama A Gheith, MD PhD

  Consultant nephrologist, Hamed Al-Essa organ transplnat center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior specialist diabetes educator

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: July 23, 2019
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)