Intensive Care Program for Youth With Diabetes

Joslin Diabetes Center

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Care Ambassador Intervention; Behavioral: Psychoeducational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00961974

02-06

R01DK046887 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 3 patient groups

Standard Care

No Intervention group

Description:

* 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 Plus

Experimental group

Description:

* 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

Treatment:

Behavioral: Care Ambassador Intervention

Care Ultra

Experimental group

Description:

* 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

Treatment:

Behavioral: Care Ambassador Intervention

Behavioral: Psychoeducational Intervention