## Protocol Section
### Identification Module
**NCT ID:** NCT06412601

**Brief Title:** Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes

**Official Title:** Happy Bob App: A Preliminary Evaluation of Its Use in Youth With Diabetes

#### Organization Study ID Info
**ID:** STUDY00002907
#### Organization
**Class:** OTHER
**Full Name:** Children's Mercy Hospital Kansas City
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-18
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Mercy Hospital Kansas City

#### Responsible Party

**Investigator Affiliation:** Children's Mercy Hospital Kansas City

**Investigator Full Name:** Mark Clements

**Investigator Title:** Medical Director, Pediatric Clinical Research Unit, Children's Mercy Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to evaluate the impact of peer support via the Happy Bob phone app in youth with Type 1 Diabetes.

The main questions it aims to answer are: What is the usability and acceptability of the app? What is the app's efficacy on measures such as treatment adherence and social support? And how are these effects impacted by remote patient monitoring by clinic staff?

Participants will use the Happy Bob app for 6 months and will complete a series of surveys at the start, middle, and end of their use of the app. Some participants will participate in 2 remote patient monitoring sessions when beginning their use of the app.

### Conditions Module

**Conditions:**

- Type 1 Diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: RPM

- Behavioral: app

**Label:** RPM (remote patient monitoring)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: app

**Label:** Non-RPM

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- RPM (remote patient monitoring)

**Description:** remote patient monitoring by clinic staff

**Name:** RPM

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Non-RPM

- RPM (remote patient monitoring)

**Description:** use of Happy Bob phone app

**Name:** app

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** time spent in Happy Bob,

**Measure:** Happy Bob App User Metrics

**Time Frame:** 6 months

**Description:** quality of life scale

**Measure:** Type 1 Diabetes and Life (T1DAL) Measure

**Time Frame:** 0,3,6 months

**Description:** mood scale

**Measure:** Positive and Negative Affect Schedule (PANAS)

**Time Frame:** 0,3,6 months

**Description:** intervention satisfaction

**Measure:** Diabetes Treatment Satisfaction Questionnaire

**Time Frame:** 0,3,6 months

**Description:** social quality of life

**Measure:** Social Support Questionnaire for Children (SSQC)

**Time Frame:** 0,3,6 months

**Description:** usability scale

**Measure:** Health Information Technology Usability Evaluation Scale (Health-ITUES)

**Time Frame:** 0,3,6 months

#### Secondary Outcomes

**Description:** efficacy scale

**Measure:** Self Efficacy for Diabetes (SED) Scale

**Time Frame:** 0,3,6 months

**Description:** TIR,

**Measure:** Diabetes Treatment Outcomes

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria:

Non-English Speaking

**Healthy Volunteers:** True

**Maximum Age:** 215 Months

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** snmaccoll@cmh.edu

**Name:** Sophie MacColl

**Phone:** 8166011485

**Role:** CONTACT

### 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

### 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: LOW

- As Found: Unknown

- 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

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-31
