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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
65
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.
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.
Children's Healthcare of Atlanta-Egleston
Atlanta, Georgia, United States
Emory Children's Center
Atlanta, Georgia, United States
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.
Time frame: Baseline, interval, and end of participation (Up to 18 years of age)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: Baseline, interval, and end of participation (Up to 18 years)