Diabetes Journey: An Adolescent Adherence Barriers Intervention

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04404556
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Diabetes Journey — BEHAVIORAL
    Web-based telehealth intervention focused on adherence barriers and problem-solving
  • Enhanced Standard of Care — BEHAVIORAL
    General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Study Details

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.

Key Dates

Start date
Aug 10, 2020
Status verified
Jun 2025
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
195 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Diabetes Journey
    Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
  • Active Comparator: Enhanced Standard of Care
    Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.

Primary Outcome Measure

Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale [ Time Frame: 6-month follow-up ]

Locations (2)

FacilityCityStateZIP
University of FloridaGainesvilleFlorida32610-0165
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229

Find similar trials in Gainesville, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Florida· Gainesville, FLCincinnati Children's Hospital Medical Center· Cincinnati, OH

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