Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

Study Overview
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Brief Summary
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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
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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: facilitate the adjustment of children and their families to the rigors of diabetes care improve adherence to medication regimens reduce acute complications of diabetes and organ rejection.

Official Title
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Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

Conditions
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Complications of Transplanted Organs and Tissue

Intervention / Treatment
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* Behavioral: Psychologist Support
* Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants<br>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<br>* 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.<br>Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Endocrinology, Pediatrics