NCT03844126

Brief Summary

A dedicated pre-transition class, as proposed in this study, could help facilitate a smooth transition between pediatric and adult diabetes care. The innovation in this study is that these classes are an opportunity for the patients and their families to meet with the Adult Diabetes Team consisting of a diabetologist, RD and CDE, prior to the transition of care. Having met them would then increase the likelihood of compliance with the Adult clinic visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

June 11, 2018

Last Update Submit

December 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Transition preparedness

    Patients with be given the modified TRAQ questionnaire before and after the program. A team consisting of an adult diabetes provider, diabetes nurse educator and dietitian will meet in small groups with adolescents between ages 16-18 years to provide them with 'adult specific' goals and discuss various topics like college preparedness, expectations from adult providers, potential changes in dynamics of diabetes management etc.

    1 month

Study Arms (1)

Patients attending the classes

EXPERIMENTAL

The patients attending the transition classes will receive a survey to assess transition preparedness before and after attending the class.

Other: Transition classes

Interventions

90 minutes spent with patients and their families (separately) to review the changes and challenges associated with healthcare transition and help alleviate some of the barriers traditionally associated with this process.

Patients attending the classes

Eligibility Criteria

Age16 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents with Type 1 Diabetes

You may not qualify if:

  • Not wanting to participate in the classes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Kanthi Bangalore Krishna, MD

    PSHMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Pediatrics

Study Record Dates

First Submitted

June 11, 2018

First Posted

February 18, 2019

Study Start

April 13, 2018

Primary Completion

April 30, 2020

Study Completion

June 30, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations