Intensive Care Program for Youth With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

* 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Care Plus

* 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

Group Type EXPERIMENTAL

Care Ambassador Intervention

Intervention Type BEHAVIORAL

Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.

Care Ultra

* 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

Group Type EXPERIMENTAL

Care Ambassador Intervention

Intervention Type BEHAVIORAL

Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.

Psychoeducational Intervention

Intervention Type BEHAVIORAL

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".

Interventions

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Care Ambassador Intervention

Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.

Intervention Type BEHAVIORAL

Psychoeducational Intervention

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".

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No