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Clinical Trials/NCT03998475
NCT03998475
Completed
Not Applicable

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

Virginia Commonwealth University1 site in 1 country62 target enrollmentJuly 11, 2019
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Virginia Commonwealth University
Enrollment
62
Locations
1
Primary Endpoint
Number of session views
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2019
End Date
September 16, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • greater than 18 years of age
  • provide care to the young adult with T1D
  • are willing to participate in the intervention
  • Medical providers

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
  • 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

Outcomes

Primary Outcomes

Number of session views

Time Frame: 6 months

Number of opened electronic materials (e.g., opened messages in the patient health portal))

Number of sessions attended

Time Frame: 6 months

Number of study visits (attendance)

Program acceptability - young adult

Time Frame: 9 months

Young adult report on satisfaction with the program via an exit survey

Program acceptability - provider

Time Frame: 9 months

Provider report on satisfaction with the program via an exit survey

Program acceptability - parent

Time Frame: 9 months

Parent report on satisfaction with the program via an exit survey

Secondary Outcomes

  • Diabetes-related hospitalizations(9 months)
  • Change in adherence to diabetes care regimen(Baseline to 9 months)
  • Change in transition readiness(Baseline to 9 months)
  • Change in Glycemic control(Baseline to 9 months)

Study Sites (1)

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