Intensive Care Program for Youth With Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Care Ambassador Intervention; Behavioral: Psychoeducational Intervention

• Registration Number: NCT00961974
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Age 8-16 years
• Type 1 diabetes diagnosed by standard American Diabetes Association criteria
• Type 1 diabetes duration of at least 6 months
• Residence in northeastern U.S.
• Established clinic patient
• Fluency in English or Spanish

Exclusion Criteria

• Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
• Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Plus	Care Ambassador Intervention	* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns
Care Ultra	Care Ambassador Intervention	* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns
Care Ultra	Psychoeducational Intervention	* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns

Primary Outcome Measures

Name	Time	Method
Glycemic control, assessed by hemoglobin A1c	Every 3 months

Secondary Outcome Measures

Name	Time	Method
Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)	Annually
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)	Every 3 months
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia	Every 3 months

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States