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NCT06412601 Clinical Trial

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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06412601
Other study ID # STUDY00002907
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source Children's Mercy Hospital Kansas City
Contact Sophie MacColl
Phone 8166011485
Email snmaccoll@cmh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 215 Months
Eligibility Inclusion Criteria: Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone Exclusion Criteria: Non-English Speaking

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• RPM
remote patient monitoring by clinic staff
• app
use of Happy Bob phone app

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

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