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

May 8, 2024 updated by: Mark Clements, Children's Mercy Hospital Kansas City

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria:

Non-English Speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RPM (remote patient monitoring)
Behavioral: RPM
remote patient monitoring by clinic staff
Behavioral: app
use of Happy Bob phone app
Active Comparator: Non-RPM
Behavioral: app
use of Happy Bob phone app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Happy Bob App User Metrics
Time Frame: 6 months
time spent in Happy Bob,
6 months
Type 1 Diabetes and Life (T1DAL) Measure
Time Frame: 0,3,6 months
quality of life scale
0,3,6 months
Positive and Negative Affect Schedule (PANAS)
Time Frame: 0,3,6 months
mood scale
0,3,6 months
Diabetes Treatment Satisfaction Questionnaire
Time Frame: 0,3,6 months
intervention satisfaction
0,3,6 months
Social Support Questionnaire for Children (SSQC)
Time Frame: 0,3,6 months
social quality of life
0,3,6 months
Health Information Technology Usability Evaluation Scale (Health-ITUES)
Time Frame: 0,3,6 months
usability scale
0,3,6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Efficacy for Diabetes (SED) Scale
Time Frame: 0,3,6 months
efficacy scale
0,3,6 months
Diabetes Treatment Outcomes
Time Frame: 6 months
TIR,
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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