Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.

Study Overview

• Status: Completed
• Conditions: Complications of Transplanted Organs and Tissue
• Intervention / Treatment: Behavioral: Psychologist Support; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support

Detailed Description

This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:

1. facilitate the adjustment of children and their families to the rigors of diabetes care
2. improve adherence to medication regimens
3. reduce acute complications of diabetes and organ rejection.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta-Egleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant

Exclusion Criteria:

• Received a transplant after 18 years of age
• Cognitively unable to participant as determined by the study team psychologist
• Not receiving a solid organ transplant for kidney, liver, or heart
• Declines participation invitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Participants; Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.

Behavioral: Psychologist Support; Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support; Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)	The Pediatric Quality of Life Inventory Transplant Module (PedsQL) is a 15 minute survey intended to measure emotional and physical function in children and determine state of wellbeing.	Baseline, interval, and end of participation (Up to 18 years of age)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplant Rejection Rate Post Diabetes Diagnosis	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.	Up to three years
Rate of Vascular Disease Post Diabetes Diagnosis	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.	Up to three years
Mortality Rate Post Diabetes Diagnosis	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.	Up to three years
Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score	The Wechsler Abbreviated Scale of Intelligence II (WASI-II) is intended to determine cognitive ability for use in educational, as well as clinical and research settings. The WASI-II is ideal for any subject over the age of six, and takes approximately one hour to complete.	Baseline, interval, and end of participation (Up to 18 years)
Change in the Children Depression Inventory (CDI 2) Score	The Children Depression Inventory (CDI 2) is a short ten minute self-reported survey intended to aid in the assessment of signs of depression in children ages seven through 17. This test helps determine negative mood, poor self-esteem, a loss of interest in activities, interpersonal problems, and feelings of ineffectiveness, the common traits of depression.	Baseline, interval, and end of participation (Up to 18 years)
Change in the Behavior Assessment System for Children (BASC) Score	The Behavior Assessment System for Children (BASC) takes approximately 15 minutes to complete and is intended to determine emotional and behavioral change in children, as well as to indicate risks to their health and development	Baseline, interval, and end of participation (Up to 18 years)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Nina Ham, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2016
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Pediatrics; Endocrinology
• Other Study ID Numbers: IRB00081257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No