School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— SPACE  

Official title:

School Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: A Pilot Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420661
• Other study ID #: STUDY23120069
• Secondary ID: 1K23DK135800-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Christine A March, MD
• Phone: 412-692-9156
• Email: christine.eklund[@]chp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2027
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• SPACE for T1D
school-partnered collaborative care model
• Enhanced usual care
routine diabetes care with optional monthly insulin dose adjustment

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Measure (FIM)	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%).	Month 4
Secondary	Acceptability of Intervention Measure (AIM)	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%).	Month 4
Secondary	Intervention Appropriateness Measure (IAM)	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%).	Month 4
Secondary	Intervention Usability Scale (IUS)	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%).	Month 4