Clinical trial NCT06420661: School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes
Official title: School Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: A Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Keywords: school
collaborative care model
diabetes care and education
health services
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.

Detailed description: This pilot cluster randomized controlled trial will examine the feasibility of a school-partnered collaborative care (SPACE) model for children with type 1 diabetes (SPACE for T1D). School districts will be randomized to the intervention or control arm in a 2:1 allocation ratio. School districts randomized to the control arm in Year 1 of the study will be invited to participate in SPACE in Year 2. All children with type 1 diabetes meeting inclusion criteria in each school district will be approached to participate through their school nurse.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least 6 months
* 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 has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires
* Child is completely independent in diabetes care in school

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Month 4
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Month 4
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Month 4
measure: Intervention Usability Scale (IUS)
timeFrame: Month 4
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Univeristy of Pittsburgh
name: Christine A March, MD
role: PRINCIPAL_INVESTIGATOR
References: