Diabetes Journey: An Adolescent Adherence Barriers Intervention

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Adherence, Patient
• Interventions: Behavioral: Enhanced Standard of Care; Behavioral: Diabetes Journey

• Registration Number: NCT04404556
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-08-10
• Primary Completion: 2023-09-30
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Standard of Care	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.
Diabetes Journey	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.

Primary Outcome Measures

Name	Time	Method
Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale	6-month follow-up	Adherence Barrier
Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale	6-month follow-up	Adherence Barrier2

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1C	6-month follow-up	Fingerstick Blood Sample
Adherence for Continuous Glucose Monitors	6-month follow-up	% Time in Range for those on continuous glucose monitors
Type 1 Diabetes and Life -Parent Report	6-month follow-up	Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Adherence for Insulin Pump Users 1	6-month follow-up	# insulin boluses per day for insulin pump users
Adherence for Insulin Pump Users	6-month follow-up	# carbohydrate entries per day for insulin pump users
Adherence for Insulin Pump Users 2	6-month follow-up	# insulin boluses followed by high blood glucose input per day for insulin pump users
Type 1 Diabetes and Life -Youth Report	6-month follow-up	Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Adherence	6-month follow-up	# blood glucose checks per day

Trial Locations

Locations (2)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States