We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745342
First Posted: September 3, 2008
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center
August 29, 2008
September 3, 2008
August 2, 2017
March 1999
October 2002   (Final data collection date for primary outcome measure)
Glycemic control, assessed by hemoglobin A1c [ Time Frame: 2 years ]
Change in A1c from baseline to 2 years, measured every 3 months
Glycemic control, assessed by hemoglobin A1c [ Time Frame: Every 3 months ]
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: 2 years ]
    Measured at baseline, 1 year, and 2 years
  • Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) [ Time Frame: 2 years ]
    Measured at baseline, 1 year, and 2 years
  • Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) [ Time Frame: 2 years ]
    Measured at baseline, 1 year, and 2 years
  • Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey [ Time Frame: Annually ]
  • Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) [ Time Frame: Annually ]
  • Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) [ Time Frame: Annually ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00745342
92-23
R01DK046887 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Lori Laffel, Joslin Diabetes Center
Joslin Diabetes Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Lori MB Laffel, MD, MPH Joslin Diabetes Center
Joslin Diabetes Center
August 2017

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