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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

NCT ID: NCT03998475

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2020-09-16

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.

Conditions

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Type 1 Diabetes

Keywords

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Transition Young Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Transition preparation program

Transition preparation intervention for young adults with type 1 diabetes (T1D)

Group Type EXPERIMENTAL

Transition preparation intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Transition preparation intervention

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Caccavale, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Melanie Melanie, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Children's Hospital of Richmond at Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1-19-PDF-041-R

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20015399

Identifier Type: -

Identifier Source: org_study_id