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

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

MedlinePlus related topics:

Diabetes Diabetes Type 1

Drug Information available for:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:	Optimizing Adherence and Glycemia in Youth With New IDDM

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
Teamwork Group: Experimental 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.
Standard Care: No Intervention 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 of Results:

Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42.

Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16.

Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73.

Responsible Party:	Joslin Diabetes Center ( Lori M.B. Laffel, MD, MPH )
Study ID Numbers:	92-23, NIH DK-46-887-04
First Received:	August 29, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745342
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

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Quality of Life

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Joslin Diabetes Center
Information provided by:	Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT00745342