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Diabetes Journey: An Adolescent Adherence Barriers Intervention

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ClinicalTrials.gov Identifier: NCT04404556
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Adherence, Patient Behavioral: Diabetes Journey Behavioral: Enhanced Standard of Care Phase 2

Detailed Description:
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Masking: Single (Care Provider)
Masking Description: Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
Primary Purpose: Treatment
Official Title: Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.
Behavioral: Diabetes Journey
Web-based telehealth intervention focused on adherence barriers and problem-solving
Other Name: mHealth problem-solving adherence barriers intervention

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.
Behavioral: Enhanced Standard of Care
General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
Other Name: t1dtoolkit




Primary Outcome Measures :
  1. Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale [ Time Frame: 6-month follow-up ]
    Adherence Barrier

  2. Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale [ Time Frame: 6-month follow-up ]
    Adherence Barrier2


Secondary Outcome Measures :
  1. Adherence for Continuous Glucose Monitors [ Time Frame: 6-month follow-up ]
    % Time in Range for those on continuous glucose monitors

  2. Adherence [ Time Frame: 6-month follow-up ]
    # blood glucose checks per day

  3. Adherence for Insulin Pump Users [ Time Frame: 6-month follow-up ]
    # carbohydrate entries per day for insulin pump users

  4. Adherence for Insulin Pump Users 1 [ Time Frame: 6-month follow-up ]
    # insulin boluses per day for insulin pump users

  5. Adherence for Insulin Pump Users 2 [ Time Frame: 6-month follow-up ]
    # insulin boluses followed by high blood glucose input per day for insulin pump users

  6. Hemoglobin A1C [ Time Frame: 6-month follow-up ]
    Fingerstick Blood Sample

  7. Type 1 Diabetes and Life -Youth Report [ Time Frame: 6-month follow-up ]
    Quality of Life Scores range from 0-100, with higher scores indicating better quality of life

  8. Type 1 Diabetes and Life -Parent Report [ Time Frame: 6-month follow-up ]
    Quality of Life Scores range from 0-100, with higher scores indicating better quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404556


Contacts
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Contact: Avani C Modi, Ph.D. 513-636-4864 avani.modi@cchmc.org
Contact: Kimberly A Driscoll, Ph.D. 352-273-6145 k.driscoll@phhp.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610-0165
Contact: Kimberly Driscoll, Ph.D.    352-273-6145    k.driscoll@phhp.ufl.edu   
Principal Investigator: Kimberly Driscoll, Ph.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Avani Modi, Ph.D.    513-636-4864    avani.modi@cchmc.org   
Principal Investigator: Avani C Modi, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
University of Florida
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04404556    
Other Study ID Numbers: 2020-0162
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Adolescent
mHealth
executive functioning skills
adherence barriers
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases