School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes
NCT ID: NCT06420661
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-08-21
2027-04-30
Brief Summary
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Detailed Description
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All research activities will be conducted using a virtual video-conferencing platform. The intervention arm will consist of four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and any other identified school-related support people. The purpose of these meetings will be to determine a shared treatment plan, make treatment recommendations, and determine progress towards meeting the child's goals. The control arm will receive usual care in the school and the clinical setting as well as monthly phone calls from the DCES to the parent to offer review of blood glucoses. No additional contact with the school will be offered.
Participants and their parents will be asked to complete surveys regarding their overall health and well-being and provide us access to their glucometer/continuous glucose monitor data. Additional information will be collected from the electronic health record (hemoglobin A1c, care utilization, referrals). At the end of study, surveys for the parent and school nurse will assess feasibility and other implementation outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SPACE Intervention
The intervention consists of four monthly virtual visits between the school nurse, diabetes care and education specialist (DCES), parent, and any other school-related supports identified by the parent (e.g., coaches, counselors, social workers). At the first visit, the parent and child, school nurse, and DCES will discuss and determine a shared treatment plan. This will include a diabetes medical management plan and shared treatment goals for the child. At each virtual visit, the DCES and school nurse will co-lead the group through review of the shared treatment plan, a review of glucose records and insulin dosing for diabetes management, provide counseling/education, and identify any needed internal (academic) or external (health-related) supports or referrals. Families will be encouraged to set new treatment goals if any milestones are met.
SPACE for T1D
school-partnered collaborative care model
Control
In addition to usual care (clinical and in school), parents of children enrolled in the control group will receive four monthly phone calls from the DCES to review diabetes management, mirroring the timing of the virtual visits of the intervention group. This study will employ a wait list control.
Enhanced usual care
routine diabetes care with optional monthly insulin dose adjustment
Interventions
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SPACE for T1D
school-partnered collaborative care model
Enhanced usual care
routine diabetes care with optional monthly insulin dose adjustment
Eligibility Criteria
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Inclusion Criteria
* Attend school in one of the partnered school districts
* Receive daily oversight from the school nurse for their diabetes
* Managed by the Children's Hospital of Pittsburgh Diabetes center
* Able to participate in English
Exclusion Criteria
* Child is completely independent in diabetes care in school
5 Years
12 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Christine March
Assistant Professor of Pediatrics
Principal Investigators
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Christine A March, MD
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY23120069
Identifier Type: -
Identifier Source: org_study_id
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