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Transition Care Program for Type 1 Diabetes (SHIFT2 Trial)
N/A
Recruiting
Led By Laura Caccavale
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
AYA: 16-22 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
SHIFT2 Trial Summary
This trial will evaluate a program to help young people with type 1 diabetes transition to adult endocrinology care, including support for them and their caregivers.
Who is the study for?
This trial is for English-speaking adolescents and young adults aged 16-22 with Type 1 Diabetes, who have been patients at the Children's Hospital of Richmond for over a year. They must have a caregiver over 18 willing to participate. Excluded are those with psychiatric disorders, non-Type 1 diabetes, recent severe mental health issues, current pregnancy or breastfeeding, or involvement in conflicting studies.Check my eligibility
What is being tested?
The study evaluates a transition preparation program aimed at supporting young individuals with Type 1 Diabetes as they shift from pediatric to adult medical care. It includes educational materials and involves both the patient and their caregiver to improve self-management before transitioning.See study design
What are the potential side effects?
Since this trial focuses on education and support rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience stress or anxiety related to changes in their care routine.
SHIFT2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 16 and 22 years old.
SHIFT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1C (HbA1C)
Secondary outcome measures
Attendance at clinic visits
Change in Diabetes Distress
Change in Quality of Life
+6 moreOther outcome measures
Transition Status
SHIFT2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: SHIFT2Experimental Treatment1 Intervention
Adolescents and young adults will engage in routine medical visits and attend 6 sessions (1x/month) focused on transition preparation and diabetes management with a transition coach and will receive bi-weekly messages during these 6-months that encourage self-management behaviors.
Parents will attend 2 sessions (month 1 and 6) with a transition coach and will receive materials, complementing their child's lesson, 1x/month for months 2-5 that focus on transition their role and supporting their child's diabetes management.
Group II: Group B: TAU+/ControlPlacebo Group1 Intervention
Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,935 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,482 Total Patients Enrolled
Laura CaccavalePrincipal InvestigatorVirginia Commonwealth University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old and a caregiver.I do not have any mental or physical conditions that would stop me from managing my diabetes.I have diabetes that is not type 1, possibly caused by medication.I have had Type 1 Diabetes for at least a year.If you have been part of the SHIFT pilot study before, you cannot participate as a caregiver.You are a patient at the Children's Hospital of Richmond in the Division of Pediatric Endocrinology.I am currently pregnant, was pregnant in the last 6 months, am breastfeeding, or plan to become pregnant in the next year.I speak English.You have ever had a psychotic disorder in your life.I am between 16 and 22 years old.You have participated in the SHIFT pilot study before.I have been hospitalized for depression or other mental health issues in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: TAU+/Control
- Group 2: Group A: SHIFT2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment actively recruiting participants?
"According to clinicaltrials.gov, this research study has ceased recruitment activities for the time being - its first posting was on June 1st 2023 and it's last update occurred on November 28th 2022. Fortunately, 1269 other trials are still actively searching for volunteers at present."
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