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Intensive Care Program for Youth With Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Ambassador Intervention
Psychoeducational Intervention
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Joslin Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard Care

Care Plus

Care Ultra

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Glycemic control, assessed by hemoglobin A1c

Secondary Outcome Measures

Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia

Full Information

First Posted
August 18, 2009
Last Updated
August 3, 2021
Sponsor
Joslin Diabetes Center
Collaborators
Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00961974
Brief Title
Intensive Care Program for Youth With Diabetes
Official Title
Intensive Care Program for Youth With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, hemoglobin A1c, family, involvement, responsibility, conflict, quality of life, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Arm Title
Care Plus
Arm Type
Experimental
Arm Description
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
Arm Title
Care Ultra
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Care Ambassador Intervention
Intervention Description
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Intervention
Intervention Description
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".
Primary Outcome Measure Information:
Title
Glycemic control, assessed by hemoglobin A1c
Time Frame
Every 3 months
Secondary Outcome Measure Information:
Title
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
Title
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
Time Frame
Every 3 months
Title
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori 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
18774997
Citation
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.
Results Reference
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PubMed Identifier
17307546
Citation
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.
Results Reference
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PubMed Identifier
15570991
Citation
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.
Results Reference
background
PubMed Identifier
23914987
Citation
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.
Results Reference
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Intensive Care Program for Youth With Diabetes

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