Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

NCT02605200 | Completed

• 1 other identifier: IRB00081257
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Complications of Transplanted Organs and Tissue

Keywords

Diabetes; Endocrinology; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Transplant Rejection Rate Post Diabetes Diagnosis

  Up to three years

• Rate of Vascular Disease Post Diabetes Diagnosis

  Up to three 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 Children Depression Inventory (CDI 2) Score

  Baseline, interval, and end of participation (Up to 18 years)

Study Arms (1)

Participants

OTHER

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; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support

Interventions

Psychologist Support BEHAVIORAL

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.

Participants

Pediatric Certified Diabetes Educators (CDEs) Support BEHAVIORAL

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.

Participants

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Children's Healthcare of Atlanta-Egleston

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nina Ham, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: November 16, 2015
• Study Start: July 7, 2016
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

US (2)