Transition Preparation Intervention for Young Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

Detailed Description
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The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.

Official Title
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Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Transition preparation intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both members of the youth/parent dyad must meet all eligibility criteria Young adults English-speaking patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU) between ages 18-22 yrs with a diagnosis of T1D for >1 year Parents greater than 18 years of age provide care to the young adult with T1D are willing to participate in the intervention Medical providers • provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR Exclusion Criteria: Young adults significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes Parents non-English speaking psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transition preparation program<br>Transition preparation intervention for young adults with type 1 diabetes (T1D) | Behavioral: Transition preparation intervention<br>* Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions attended | Number of study visits (attendance) | 6 months | 
| Number of session views | Number of opened electronic materials (e.g., opened messages in the patient health portal)) | 6 months | 
| Program acceptability - young adult | Young adult report on satisfaction with the program via an exit survey | 9 months | 
| Program acceptability - parent | Parent report on satisfaction with the program via an exit survey | 9 months | 
| Program acceptability - provider | Provider report on satisfaction with the program via an exit survey | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic control | Measurement of hemoglobin A1c (A1c; reported as a percentage) | Baseline to 9 months | 
| Diabetes-related hospitalizations | Participant report and medical record review of count of reported diabetes-related hospitalizations and complications | 9 months | 
| Change in adherence to diabetes care regimen | Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ) | Baseline to 9 months | 
| Change in transition readiness | Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ) | Baseline to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition, Young Adult