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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00745342
First received: August 29, 2008
Last updated: July 7, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Laffel, Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section, 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: July 7, 2014
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014