Intensive Care Program for Youth With Diabetes

NCT00961974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2021-08-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Care Ambassador Intervention

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

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".

Sponsors & Collaborators

  • Charles H. Hood Foundation

    collaborator OTHER
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Lori Laffel, MD, MPH · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961974 on ClinicalTrials.gov