115 Participants Needed

Transition Care Program for Type 1 Diabetes

(SHIFT2 Trial)

SF
LC
Overseen ByLaura Caccavale
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Commonwealth University

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Transition Care Program for Type 1 Diabetes safe for humans?

The research articles do not provide specific safety data for the Transition Care Program for Type 1 Diabetes, but they focus on improving the transition from pediatric to adult care, which is generally considered safe as it involves educational and support strategies.12345

How is the Transition Care Program for Type 1 Diabetes different from other treatments?

The Transition Care Program for Type 1 Diabetes is unique because it focuses on empowering adolescents and young adults to take an active role in their health as they move from pediatric to adult care, unlike traditional treatments that primarily focus on medical management. This program includes person-centered strategies and structured support to help young patients manage their condition independently, which is not typically emphasized in standard diabetes care.16789

What data supports the effectiveness of the Transition Care Program for Type 1 Diabetes treatment?

Research shows that structured transition programs can improve the process of moving from pediatric to adult care for young adults with type 1 diabetes, leading to better clinic attendance, patient satisfaction, and knowledge about managing their condition.24101112

Who Is on the Research Team?

LC

Laura Caccavale

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

AYA: must have a caregiver willing to participate
I have had Type 1 Diabetes for at least a year.
You are a patient at the Children's Hospital of Richmond in the Division of Pediatric Endocrinology.
See 2 more

Exclusion Criteria

AYA: Another member of the household (other than the participating parent) is a participant or staff member on this study
Caregiver: Participation in another research study that may interfere with current study
Caregiver: Another member of the home (not AYA) is a participant/staff member on current study
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month transition preparation program with monthly sessions and bi-weekly messages for diabetes management

6 months
6 visits (in-person), bi-weekly virtual messages

Follow-up

Participants are monitored for changes in diabetes distress, support, adherence, self-efficacy, quality of life, and HbA1C

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Educational materials
  • Transition preparation program
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: SHIFT2Experimental Treatment1 Intervention
Group II: Group B: TAU+/ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

The study compared a comprehensive transition program (CTP) to standard clinical practice (SCP) for young people with type 1 diabetes mellitus transitioning to adult care, finding that both groups had high retention rates in adult services, but the CTP group had a higher baseline and follow-up HbA1c level.
Despite the lack of significant differences in retention or engagement, the study highlights the need for more randomized controlled trials to better understand effective transition strategies for young people with T1DM.
A pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care.Steinbeck, KS., Shrewsbury, VA., Harvey, V., et al.[2022]
Adolescents with type 1 diabetes face challenges in transitioning from pediatric to adult care, particularly in managing relationships with parents and healthcare teams, which can impact their health outcomes.
To improve transition care, programs should focus on enhancing self-management skills tailored to the age of diagnosis and provide support for navigating the healthcare system, involving both parents and peers in the process.
Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents.Ladd, JM., Reeves-Latour, J., Dasgupta, K., et al.[2022]
A half-day transfer clinic for young adults with type 1 diabetes significantly improved patient and parent satisfaction during the transition from pediatric to adult care, with all attendees reporting high levels of satisfaction.
The clinic's structure was successfully modified based on initial feedback, demonstrating that such a program can be efficiently implemented without requiring additional staff or significant resources, making it a practical solution for other chronic disease transitions.
Improving the transitioning of pediatric patients with type 1 diabetes into adult care by initiating a dedicated single session transfer clinic.Williams, S., Newhook, LAA., Power, H., et al.[2022]

Citations

A pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care. [2022]
Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. [2022]
Improving the transitioning of pediatric patients with type 1 diabetes into adult care by initiating a dedicated single session transfer clinic. [2022]
[Diabetes mellitus at the interface between pediatric and adult medicine]. [2019]
Building the bridge from pediatric to adult diabetes care: making the connection. [2022]
Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. [2021]
The experiences and impact of transition from child to adult healthcare services for young people with Type 1 diabetes: a systematic review. [2022]
Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. [2022]
[Transition of young adults with type 1 diabetes mellitus from a pediatric to adult diabetes clinic - problems, challenges and recommendations]. [2017]
Type 1 diabetes: addressing the transition from pediatric to adult-oriented health care. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Health Care Transition for Young Adults With Type 1 Diabetes: Stakeholder Engagement for Defining Optimal Outcomes. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Development and design of the first structured clinic-based program in lower resource settings to transition emerging adults with type 1 diabetes from pediatric to adult care. [2023]
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