- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420661
School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes (SPACE)
School Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: A Pilot Feasibility Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christine A March, MD
- Phone Number: 412-692-9156
- Email: christine.eklund@chp.edu
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15237
- University of Pittsburgh
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Contact:
- Christine A March, MD, MS
- Phone Number: 412-692-9156
- Email: christine.eklund@chp.edu
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Contact:
- Victoria Stouffer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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school-partnered collaborative care model
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Active Comparator: 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.
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routine diabetes care with optional monthly insulin dose adjustment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Intervention Measure (FIM)
Time Frame: Month 4
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The primary outcome is feasibility, defined as the extent to which the intervention can be successfully carried out in the school setting.
Feasibility will be measured by the FIM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree.
The scale scores can range from 1-5 with higher scores indicating higher feasibility.
The FIM will be completed by the participating child's parent and school nurse.
The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times.
Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time.
The intervention will be deemed "feasible" if the mean overall score is >4/5 (80%).
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Month 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM)
Time Frame: Month 4
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Acceptability is defined as the perception that the intervention is agreeable or satisfactory.
Acceptability will be measured with AIM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree.
The scale scores can range from 1-5 with higher scores indicating higher acceptability.
The AIM will be completed by the participating child's parent and school nurse.
The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times.
Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time.
The intervention will be deemed "acceptable" if the mean overall score is >4/5 (80%).
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Month 4
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Intervention Appropriateness Measure (IAM)
Time Frame: Month 4
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Appropriateness is defined as the perceived fit or relevance of the intervention to the school setting.
Appropriateness will be measured with the IAM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree.
The scale scores can range from 1-5 with higher scores indicating higher appropriateness.
The IAM will be completed by the participating child's parent and school nurse.
The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times.
Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time.
The intervention will be deemed "appropriate" if the mean overall score is >4/5 (80%).
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Month 4
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Intervention Usability Scale (IUS)
Time Frame: Month 4
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Usability is defined as the degree to which the intervention is able to be used.
Usability will be measured by the IUS, a 10-item scale with an ordinal scoring system from strongly disagree to strongly agree.
The scale scores can range from 1-5 with higher scores indicating higher usability.
The IUS will be completed by the participating child's parent and school nurse.
The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times.
Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time.
The intervention will be deemed "usable" if the mean overall score is >4/5 (80%).
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Month 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine A March, MD, Univeristy of Pittsburgh
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23120069
- 1K23DK135800-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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