Clinical trial NCT04404556: Diabetes Journey: An Adolescent Adherence Barriers Intervention
Official title: Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Adherence, Patient
Keywords: Adolescent
mHealth
executive functioning skills
adherence barriers
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2020-05-27
Enrollment: 195
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale
timeFrame: 6-month follow-up
measure: Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Adherence for Continuous Glucose Monitors
timeFrame: 6-month follow-up
measure: Adherence
timeFrame: 6-month follow-up
measure: Adherence for Insulin Pump Users
timeFrame: 6-month follow-up
measure: Adherence for Insulin Pump Users 1
timeFrame: 6-month follow-up
measure: Adherence for Insulin Pump Users 2
timeFrame: 6-month follow-up
measure: Hemoglobin A1C
timeFrame: 6-month follow-up
measure: Type 1 Diabetes and Life -Youth Report
timeFrame: 6-month follow-up
measure: Type 1 Diabetes and Life -Parent Report
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: