## Protocol Section
### Identification Module
**NCT ID:** NCT06420661

**Acronym:** SPACE

**Brief Title:** 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

#### Organization Study ID Info
**ID:** STUDY23120069
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
#### Secondary ID Infos
**ID:** 1K23DK135800-01
**Link:** https://reporter.nih.gov/quickSearch/1K23DK135800-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pittsburgh

#### Responsible Party

**Investigator Affiliation:** University of Pittsburgh

**Investigator Full Name:** Christine March

**Investigator Title:** Assistant Professor of Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 1 Diabetes

**Keywords:**

- school

- collaborative care model

- diabetes care and education

- health services

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Cluster randomized controlled trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: SPACE for T1D

**Label:** SPACE Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Enhanced usual care

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SPACE Intervention

**Description:** school-partnered collaborative care model

**Name:** SPACE for T1D

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** routine diabetes care with optional monthly insulin dose adjustment

**Name:** Enhanced usual care

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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%).

**Measure:** Feasibility of Intervention Measure (FIM)

**Time Frame:** Month 4

#### Secondary Outcomes

**Description:** 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%).

**Measure:** Acceptability of Intervention Measure (AIM)

**Time Frame:** Month 4

**Description:** 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%).

**Measure:** Intervention Appropriateness Measure (IAM)

**Time Frame:** Month 4

**Description:** 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%).

**Measure:** Intervention Usability Scale (IUS)

**Time Frame:** Month 4

### Eligibility Module

**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

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** christine.eklund@chp.edu

**Name:** Christine A March, MD

**Phone:** 412-692-9156

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pittsburgh

**Contacts:**

***Contact 1:***

- **Email:** christine.eklund@chp.edu

- **Name:** Christine A March, MD, MS

- **Phone:** 412-692-9156

- **Role:** CONTACT

***Contact 2:***

- **Name:** Victoria Stouffer

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Pittsburgh

**State:** Pennsylvania

**Zip:** 15237

#### Overall Officials

**Official 1:**

**Affiliation:** Univeristy of Pittsburgh

**Name:** Christine A March, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
