Optimizing Adherence and Glycemia in Youth With New Insulin-Dependent Diabetes Mellitus (IDDM)

This study has been completed.
Sponsor:
Information provided by:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00745342
First received: August 29, 2008
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.


Condition Intervention
Type 1 Diabetes Mellitus
Behavioral: Family Teamwork Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Adherence and Glycemia in Youth With New IDDM

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Glycemic control, assessed by hemoglobin A1c [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) [ Time Frame: Annually ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: March 1999
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teamwork Group
Families randomized to the Teamwork Group received the behavioral family teamwork intervention.
Behavioral: Family Teamwork Intervention
Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.
No Intervention: Standard Care
Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 8 to 17 years old
  • Duration of type 1 diabetes between 2 months and 6 years
  • Residence in New England or New York
  • At least 1 outpatient visit in the past year

Exclusion Criteria:

  • Major co-morbid psychiatric or medical illness in youth
  • Diagnosis of an active major psychiatric disorder in either parent
  • Diagnosis of a life-threatening medical illness in either parent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745342

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
Principal Investigator: Lori MB Laffel, MD, MPH Joslin Diabetes Center
  More Information

Publications:
Responsible Party: Lori M.B. Laffel, MD, MPH, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00745342     History of Changes
Other Study ID Numbers: 92-23, NIH DK-46-887-04
Study First Received: August 29, 2008
Last Updated: September 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
type 1 diabetes
glycemic control
family conflict
quality of life
parental involvement

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014