Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Complications of Transplanted Organs and Tissue
- Sponsor
- Emory University
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jee-Young Nina Ham
Assistant Professor
Emory University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the Pediatric Quality of Life Inventory Transplant Module (PedsQL)
Time Frame: 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 Outcomes
- Rate of Vascular Disease Post Diabetes Diagnosis(Up to three years)
- Transplant Rejection Rate Post Diabetes Diagnosis(Up to three years)
- Change in the Children Depression Inventory (CDI 2) Score(Baseline, interval, and end of participation (Up to 18 years))
- Mortality Rate Post Diabetes Diagnosis(Up to three years)
- Change in the Wechsler Abbreviated Scale of Intelligence II (WASI-II) Score(Baseline, interval, and end of participation (Up to 18 years))
- Change in the Behavior Assessment System for Children (BASC) Score(Baseline, interval, and end of participation (Up to 18 years))