Intensive Care Program for Youth With Diabetes
2 other identifiers
interventional
154
1 country
1
Brief Summary
The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2002
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedAugust 4, 2021
August 1, 2021
3.2 years
August 18, 2009
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic control, assessed by hemoglobin A1c
Every 3 months
Secondary Outcomes (3)
Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
Annually
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Every 3 months
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
Every 3 months
Study Arms (3)
Standard Care
NO INTERVENTION* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns
Care Plus
EXPERIMENTAL* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns
Care Ultra
EXPERIMENTAL* Routine diabetes support and education from diabetes health care team * Assistance from a non-medical case manager (Care Ambassador) to schedule appointments, provide reminders about appointments, and help families contact health care providers about questions or concerns
Interventions
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".
Eligibility Criteria
You may qualify if:
- Age 8-16 years
- Type 1 diabetes diagnosed by standard American Diabetes Association criteria
- Type 1 diabetes duration of at least 6 months
- Residence in northeastern U.S.
- Established clinic patient
- Fluency in English or Spanish
You may not qualify if:
- Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
- Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (4)
Butler DA, Zuehlke JB, Tovar A, Volkening LK, Anderson BJ, Laffel LM. The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):373-81. doi: 10.1111/j.1399-5448.2008.00370.x.
PMID: 18774997BACKGROUNDSvoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr. 2007 Mar;150(3):279-85. doi: 10.1016/j.jpeds.2006.12.009.
PMID: 17307546BACKGROUNDMoreland EC, Tovar A, Zuehlke JB, Butler DA, Milaszewski K, Laffel LM. The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2004 Nov;17(11):1533-44. doi: 10.1515/jpem.2004.17.11.1533.
PMID: 15570991BACKGROUNDKatz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5.
PMID: 23914987RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Laffel, MD, MPH
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
April 1, 2002
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
August 4, 2021
Record last verified: 2021-08