- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961974
Intensive Care Program for Youth With Diabetes
August 3, 2021 updated by: Lori Laffel, Joslin Diabetes Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
|
|
Experimental: Care Plus
|
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
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Experimental: Care Ultra
|
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".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic control, assessed by hemoglobin A1c
Time Frame: Every 3 months
|
Every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
Time Frame: Annually
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Annually
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Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Time Frame: Every 3 months
|
Every 3 months
|
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
Time Frame: Every 3 months
|
Every 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Svoren 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.
- Moreland 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.
- Katz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Actual)
August 4, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-06
- R01DK046887 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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