Back to resultsOptimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Teamwork Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement
Eligibility 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
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teamwork Group
Standard Care
Arm Description
Families randomized to the Teamwork Group received the behavioral family teamwork 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.
Outcomes
Primary Outcome Measures
Glycemic control, assessed by hemoglobin A1c
Change in A1c from baseline to 2 years, measured every 3 months
Secondary Outcome Measures
Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey
Measured at baseline, 1 year, and 2 years
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)
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)
Measured at baseline, 1 year, and 2 years
Full Information
NCT ID
NCT00745342
First Posted
August 29, 2008
Last Updated
August 3, 2021
Sponsor
Joslin Diabetes Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00745342
Brief Title
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Official Title
Optimizing Adherence and Glycemia in Youth With New IDDM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Joslin Diabetes Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teamwork Group
Arm Type
Experimental
Arm Description
Families randomized to the Teamwork Group received the behavioral family teamwork intervention.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Teamwork Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic control, assessed by hemoglobin A1c
Description
Change in A1c from baseline to 2 years, measured every 3 months
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey
Description
Measured at baseline, 1 year, and 2 years
Time Frame
2 years
Title
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)
Description
Measured at baseline, 1 year, and 2 years
Time Frame
2 years
Title
Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)
Description
Measured at baseline, 1 year, and 2 years
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori MB Laffel, MD, MPH
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12147143
Citation
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. doi: 10.1046/j.1464-5491.2002.00752.x.
Results Reference
result
PubMed Identifier
12712059
Citation
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. doi: 10.1067/mpd.2003.138.
Results Reference
result
PubMed Identifier
14578241
Citation
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. doi: 10.2337/diacare.26.11.3067.
Results Reference
result
Learn more about this trial
Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
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