Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

Not Applicable

Completed

• Conditions: Complications of Transplanted Organs and Tissue
• Interventions: Behavioral: Psychologist Support; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support

• Registration Number: NCT02605200
• Lead Sponsor: Emory University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-16
• Study Start: 2016-07-07
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Psychologist Support	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.
Participants	Pediatric Certified Diabetes Educators (CDEs) Support	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.

Primary Outcome Measures

Name	Time	Method
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)	Baseline, interval, and end of participation (Up to 18 years of age)	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Vascular Disease Post Diabetes Diagnosis	Up to three years	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of vascular disease after being diagnosed with diabetes.
Transplant Rejection Rate Post Diabetes Diagnosis	Up to three years	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of transplant rejection after being diagnosed with diabetes.
Change in the Children Depression Inventory (CDI 2) Score	Baseline, interval, and end of participation (Up to 18 years)	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.
Mortality Rate Post Diabetes Diagnosis	Up to three years	Participants will be followed at Children's Healthcare of Atlanta, and monitored for rates of mortality after being diagnosed with diabetes.
Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score	Baseline, interval, and end of participation (Up to 18 years)	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.
Change in the Behavior Assessment System for Children (BASC) Score	Baseline, interval, and end of participation (Up to 18 years)	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

Trial Locations

Locations (2)

Children's Healthcare of Atlanta-Egleston; 🇺🇸 Atlanta, Georgia, United States

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States