NCT03998475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

June 24, 2019

Last Update Submit

November 5, 2020

Conditions

Type 1 Diabetes

Keywords

TransitionYoung Adult

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Change in Glycemic control

    Baseline to 9 months

  • Diabetes-related hospitalizations

    9 months

  • Change in adherence to diabetes care regimen

    Baseline to 9 months

  • Change in transition readiness

    Baseline to 9 months

Other Outcomes (9)

  • Change in diabetes self-efficacy

    Baseline to 9 months

  • Change in diabetes quality of life

    Baseline to 9 months

  • Change in diabetes family responsibility

    Baseline to 9 months

  • +6 more other outcomes

Study Arms (1)

Transition preparation program

EXPERIMENTAL

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

Behavioral: Transition preparation intervention

Interventions

Transition preparation interventionBEHAVIORAL

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.

Transition preparation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Richmond at Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Laura Caccavale, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • Melanie Melanie, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

July 11, 2019

Primary Completion

September 16, 2020

Study Completion

September 16, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)