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Clinical Trials/NCT06412601
NCT06412601Active, not recruitingNot Applicable

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

Children's Mercy Hospital Kansas City2 sites in 1 country80 target enrollmentStarted: July 30, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Health Information Technology Usability Evaluation Scale (Health-ITUES)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
13 Years to 215 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria

  • Non-English Speaking

Outcomes

Primary Outcomes

Health Information Technology Usability Evaluation Scale (Health-ITUES)

Time Frame: 0,3,6 months

usability scale

Happy Bob App User Metrics

Time Frame: 6 months

time spent in Happy Bob,

Type 1 Diabetes and Life (T1DAL) Measure

Time Frame: 0,3,6 months

quality of life scale

Diabetes Treatment Satisfaction Questionnaire

Time Frame: 0,3,6 months

intervention satisfaction

Social Support Questionnaire for Children (SSQC)

Time Frame: 0,3,6 months

social quality of life

Positive and Negative Affect Schedule (PANAS)

Time Frame: 0,3,6 months

mood scale

Secondary Outcomes

  • Diabetes Treatment Outcomes(6 months)
  • Self Efficacy for Diabetes (SED) Scale(0,3,6 months)

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacob Redel

Physician

Children's Mercy Hospital Kansas City

Study Sites (2)

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