- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844126
Transition of Diabetes Care From Pediatric to Adult Healthcare Providers.
December 22, 2020 updated by: Kanthi Bangalore Krishna, Milton S. Hershey Medical Center
Adolescents With Type 1 Diabetes Who Attend Pre-transition Classes, Are Better Prepared to Transition Their Care From Pediatric to Adult Providers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adolescents with Type 1 Diabetes
Exclusion Criteria:
Not wanting to participate in the classes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients attending the classes
The patients attending the transition classes will receive a survey to assess transition preparedness before and after attending the class.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transition preparedness
Time Frame: 1 month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kanthi Bangalore Krishna, MD, PSHMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2018
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
June 11, 2018
First Submitted That Met QC Criteria
February 14, 2019
First Posted (Actual)
February 18, 2019
Study Record Updates
Last Update Posted (Actual)
December 24, 2020
Last Update Submitted That Met QC Criteria
December 22, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- STUDY0007974
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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