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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03998475
Enrollment
62
Registered
2019-06-26
Start date
2019-07-11
Completion date
2020-09-16
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Transition, Young Adult

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.

Interventions

BEHAVIORALTransition 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.

Sponsors

American Diabetes Association
CollaboratorOTHER
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of sessions attended6 monthsNumber of study visits (attendance)
Program acceptability - provider9 monthsProvider report on satisfaction with the program via an exit survey
Program acceptability - parent9 monthsParent report on satisfaction with the program via an exit survey
Program acceptability - young adult9 monthsYoung adult report on satisfaction with the program via an exit survey
Number of session views6 monthsNumber of opened electronic materials (e.g., opened messages in the patient health portal))

Secondary

MeasureTime frameDescription
Change in Glycemic controlBaseline to 9 monthsMeasurement of hemoglobin A1c (A1c; reported as a percentage)
Diabetes-related hospitalizations9 monthsParticipant report and medical record review of count of reported diabetes-related hospitalizations and complications
Change in adherence to diabetes care regimenBaseline to 9 monthsAverage of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Change in transition readinessBaseline to 9 monthsAverage of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)

Other

MeasureTime frameDescription
Change in diabetes self-efficacyBaseline to 9 monthsParticipant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
Change in diabetes family conflictBaseline to 9 monthsAverage of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)
Change in diabetes family responsibilityBaseline to 9 monthsAverage of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)
Change in diabetes quality of lifeBaseline to 9 monthsParticipant (young adult) report on the Pediatric Quality of Life Diabetes Module
Change in young adult diabetes distressBaseline to 9 monthsParticipant (young adult) report on the Diabetes Distress Scale
Change in depressionBaseline to 9 monthsParticipant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
Change in parent diabetes distressBaseline to 9 monthsParticipant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D
Change in autonomy supportBaseline to 9 monthsParticipant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire
Change in problem solvingBaseline to 9 monthsParticipant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026