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

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ClinicalTrials.gov Identifier: NCT04030013
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nashwa Othman, Dasman Diabetes Institute

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


Condition or disease Intervention/treatment Phase
New Onset Diabetes After Transplant Diabetes Mellitus Other: group education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: "Outcome of Diabetes Education Among Renal Transplant Recipients With New Onset Diabetes After Transplantation (NODAT)"
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 2018
Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group education for 2 years
Patients who will receive structured diabetes education in groups , Group 1
Other: group education
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 Names:
  • one to one
  • conventional education

Active Comparator: One to one education for 2 years
Patients who will receive one to one structured diabetes education, Group 2
Other: group education
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 Names:
  • one to one
  • conventional education

No Intervention: Control group without structured education
Patients who will not receive structured diabetes education, Group 3



Primary Outcome Measures :
  1. Evaluate the effect of diabetes education given to renal transplant recipients with new onset diabetes after transplantation . [ Time Frame: For 2 years from the time of enrolment ]
    Positive metabolic control and self-care diabetes management


Secondary Outcome Measures :
  1. comparison of type of diabetes education [ Time Frame: For 2 years from the enrolment ]
    Comparison between one to one vs. group education



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030013


Locations
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Kuwait
Dasman diabetes institute
Kuwait, Kuwait City, Kuwait, 15462
Sponsors and Collaborators
Dasman Diabetes Institute
Investigators
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Principal Investigator: Nashwa F Othman, MD PhD Senior diabetes educator in Dasman Diabetes Institute
Study Director: Osama A Gheith, MD PhD Consultant nephrologist, Hamed Al-Essa organ transplnat center

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Responsible Party: Nashwa Othman, Senior specialist diabetes educator, Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT04030013     History of Changes
Other Study ID Numbers: RA 2014-049
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nashwa Othman, Dasman Diabetes Institute:
renal
diabetes
outcome
transplant
Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases