TransitionNCT03844126
Transition of Diabetes Care From Pediatric to Adult Healthcare Providers.
A study testing Transition classes in people with Transition, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Transition
- What is being tested?
- Transition classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents with Type 1 Diabetes
Who cannot join
- Not wanting to participate in the classes
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
- Conditions
- Transition
- Being tested
- Transition classes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition classesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transition classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start13 Apr 2018
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransitionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanthi Bangalore Krishna, Milton S. Hershey Medical Center
- Investigators
- Kanthi Bangalore Krishna, MD, Principal investigator, PSHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844126
- Sponsor's protocol ID
- STUDY0007974
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2018
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescents With Type 1 Diabetes Who Attend Pre-transition Classes, Are Better Prepared to Transition Their Care From Pediatric to Adult Providers
- ClinicalTrials.gov ID
- NCT03844126
- Acronym / sponsor ID
- STUDY0007974
- Conditions
- Transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending the classes | Experimental | Other: Transition classesThe patients attending the transition classes will receive a survey to assess transition preparedness before and after attending the class. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents with Type 1 Diabetes
Key exclusion criteria (1 listed)
- Not wanting to participate in the classes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition classes90 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. | Other | Patients attending the classes |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Transition
Not yet recruiting
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Health Care Transition, Survivorship Care
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Active, not recruiting
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
Serious Games, Transition-age Youth
Not yet recruiting
Optimizing Care Transitions in CHD
Congenital Heart Disease (CHD), Mentorship
Recruiting
Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic Transition
Patients With Ultra High Risk of Psychotic Transition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanthi Bangalore Krishna, MD principal investigator
PSHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition classes in people with Transition, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition preparedness (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.