Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420661
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
School Partnered Collaborative Care SPACE Intervention for Children with Type 1 Diabetes
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
School Partnered Collaborative Care SPACE for Pediatric Type 1 Diabetes a Pilot Feasibility Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACE
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 21 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 childs 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 glucometercontinuous 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
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 childs 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 glucometercontinuous 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23DK135800-01 | NIH | None | httpsreporternihgovquickSearch1K23DK135800-01 |