NCT04404556

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

May 19, 2020

Results QC Date

February 7, 2025

Last Update Submit

June 26, 2025

Conditions

Type 1 DiabetesAdherence, Patient

Keywords

AdolescentmHealthexecutive functioning skillsadherence barriers

Outcome Measures

Primary Outcomes (2)

  • Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale

    Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.

    6-month follow-up

  • Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale

    Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.

    6-month follow-up

Secondary Outcomes (6)

  • Hemoglobin A1C

    6-month follow-up

  • Type 1 Diabetes and Life -Youth Report

    6-month follow-up

  • Adherence for Continuous Glucose Monitors

    6-month follow-up

  • Adherence

    6-month follow-up

  • Adherence for Insulin Pump Users

    6-month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Diabetes Journey

EXPERIMENTAL

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.

Behavioral: Diabetes Journey

Enhanced Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Standard of Care

Interventions

Diabetes JourneyBEHAVIORAL

Web-based telehealth intervention focused on adherence barriers and problem-solving

Also known as: mHealth problem-solving adherence barriers intervention
Diabetes Journey
Enhanced Standard of CareBEHAVIORAL

General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Also known as: t1dtoolkit
Enhanced Standard of Care

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • T1D diagnosis \>1 year
  • Adolescents with T1D ages 13-17
  • Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores
  • Ability to read/speak English (all measures are in English)

You may not qualify if:

  • Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability)
  • Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid)
  • No use of/plans to use non-insulin medication for blood glucose control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32610-0165, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Patient Compliance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Avani Modi, Ph.D.
Organization
Cincinnati Children's Hospital Medical Center
avani.modi@cchmc.org
513-636-4864

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 27, 2020

Study Start

August 10, 2020

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

July 15, 2025

Results First Posted

July 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The NIDDK Data Repository will serve as the primary data repository for the current proposal.

Time Frame
The NIDDK Data Repository will serve as the primary data repository for the current proposal. In addition, data sets may also be distributed via clinicaltrials.gov. Should individuals or organizations request the dataset directly from the principal investigators, those requests will be directed to the NIDDK Data repository to retrieve the data. Per NIDDK guidelines on resource sharing for intervention studies, baseline data will be shared within 2 years after study recruitment is complete or within six months of the publication date of the baseline data, whichever comes first. An analytic dataset for the baseline publication will be provided within 6 months of the publication date (when the publication appears online).
Access Criteria
The investigators agree that they will identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. Since the investigators will be using the NIDDK Data Repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.

Locations

US(2)