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

August 29, 2008
July 7, 2014
March 1999
October 2002   (final data collection date for primary outcome measure)
Glycemic control, assessed by hemoglobin A1c [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745342 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Optimizing Adherence and Glycemia in Youth With New IDDM

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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.
  • Experimental: Teamwork Group
    Families randomized to the Teamwork Group received the behavioral family teamwork intervention.
    Intervention: Behavioral: Family Teamwork Intervention
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
October 2002
October 2002   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00745342
92-23, NIH DK-46-887-04
Yes
Lori Laffel, Joslin Diabetes Center
Joslin Diabetes Center
Not Provided
Principal Investigator: Lori MB Laffel, MD, MPH Joslin Diabetes Center
Joslin Diabetes Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP