Intensive Care Program for Youth With Diabetes

Study Overview
=================
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.

Official Title
-----------------
Intensive Care Program for Youth With Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Care Ambassador Intervention
* Behavioral: Psychoeducational Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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 | |
| Experimental: Care Plus<br>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 | Behavioral: Care Ambassador Intervention<br>* Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.<br>|
| Experimental: Care Ultra<br>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 | Behavioral: Care Ambassador Intervention<br>* Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.<br>Behavioral: Psychoeducational Intervention<br>* A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing diabetes burnout.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control, assessed by hemoglobin A1c |  | Every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children