Transition Care Program for Type 1 Diabetes

(SHIFT2 Trial)

Overseen By Laura Caccavale

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Psychiatric disorders, Pregnancy, Others

Compensation: Varies

Number of Visits: 6

Duration: 6 months

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents and young adults with type 1 diabetes transition from pediatric to adult medical care. It tests a transition preparation program that includes coaching sessions and supportive messages to encourage self-management of diabetes. Participants will be divided into two groups: one receiving the full program with sessions and messages, and another receiving regular medical visits and monthly educational materials. Suitable candidates have had type 1 diabetes for at least a year, are patients at the Children's Hospital of Richmond, speak English, and have a caregiver willing to participate.

As an unphased trial, this study offers a unique opportunity to enhance the transition to adult care with personalized support.

Will I have to stop taking my current medications?

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

What prior data suggests that this transition preparation program is safe for adolescents and young adults with type 1 diabetes?

Research shows that programs designed to help young adults with type 1 diabetes transition to adult care are safe and well-received. Studies have found that these programs assist young people in moving to adult healthcare smoothly. Participants reported no serious issues during or after these programs. The main goal is to help young adults manage their diabetes more effectively as they age.

In other studies, young adults and their parents participated in a 6-month program to prepare for the switch to adult healthcare. This program succeeded without causing any negative effects. Participants found it useful for learning to manage their condition independently.

Overall, the transition preparation program is a proven safe way to support young people with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this Transition Care Program for Type 1 Diabetes because it focuses on empowering young people during a crucial transition period. Unlike standard care, which typically involves regular medical visits and general education, this program offers a personalized approach with sessions led by a transition coach, encouraging self-management behaviors through bi-weekly messages. Additionally, it involves parents by providing them with resources to support their child's transition, which isn't a common feature in existing treatments. This holistic and supportive approach aims to smooth the transition from pediatric to adult care, potentially improving long-term diabetes management for adolescents and young adults.

What evidence suggests that this transition preparation program is effective for adolescents and young adults with type 1 diabetes?

Research has shown that a transition preparation program can help teenagers and young adults with type 1 diabetes manage their condition better as they move from child to adult healthcare. In this trial, participants in Group A will engage in the SHIFT2 program, which aims to improve outcomes by teaching self-care skills and offering support during this important time. Studies have found that many young people with type 1 diabetes struggle to maintain their blood sugar levels within the target range during this transition. Programs like SHIFT have been linked to fewer breaks in care and fewer diabetes-related problems. Meanwhile, participants in Group B will receive educational materials as part of routine medical visits. Overall, these programs aim to make the transition to adult care smoother and safer for young people with type 1 diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

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.

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

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?

Group I: Group A: SHIFT2 Experimental Treatment 1 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+/Control Placebo Group 1 Intervention

Participants will engage in routine medical visits and will receive education materials monthly (1x/month) regarding healthcare transition and diabetes management.

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

A systematic review of 43 studies involving young people with Type 1 diabetes revealed that healthcare transitions are linked to worse clinic attendance, indicating a potential gap in care during this critical period.

While the impact on glycaemic control and hospitalizations was mixed, there is preliminary evidence suggesting that structured transition programs could improve experiences and outcomes for young patients navigating adult healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experiences and impact of transition from child to adult healthcare services for young people with Type 1 diabetes: a systematic review. Sheehan, AM., While, AE., Coyne, I.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A survey of 602 young adults with type 1 diabetes revealed that many in the pediatric group (64%) stayed in pediatric care due to emotional attachment, highlighting the importance of emotional support during the transition to adult care.

Despite receiving counseling on diabetes management, less than half of the participants discussed reproductive health, indicating a gap in comprehensive care that needs to be addressed to improve transition outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. Garvey, KC., Foster, NC., Agarwal, S., et al.[2022]

The PATHWAY program is the first structured transition initiative for young individuals with Type 1 diabetes in Delhi, India, designed to improve their transition from pediatric to adult care through a series of educational and behavioral sessions over 15 months.

The program includes a unique 'overlap period' where patients alternate visits between pediatric and adult providers, aiming to enhance self-management and clinic attendance, which is crucial for better health outcomes in emerging adults with diabetes.

NCBI (Pubmed)

pubmed.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. Cristello Sarteau, A., Peerzada, A., Goyal, A., et al.[2023]

A structured transition program for emerging adults with type 1 diabetes, involving joint appointments with pediatric and adult providers, resulted in 100% adherence to follow-up, indicating its effectiveness in facilitating the transition to adult care.

The program significantly reduced diabetes-related distress and improved perceived support from healthcare providers, suggesting that a coordinated approach can enhance both emotional well-being and health outcomes during the transition phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building the bridge from pediatric to adult diabetes care: making the connection. Egan, EA., Corrigan, J., Shurpin, K.[2022]

Effective transition from pediatric to adult diabetes care is crucial for young patients with type 1 diabetes, as it can significantly impact their ability to manage the disease independently and maintain metabolic control.

The paper highlights the importance of well-planned transition programs and provides recommendations from scientific societies to prevent deterioration in diabetes management during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transition of young adults with type 1 diabetes mellitus from a pediatric to adult diabetes clinic - problems, challenges and recommendations]. Modrzyńska, K., Szadkowska, A.[2017]

This study involved qualitative interviews with various stakeholders, including young adults with type 1 diabetes (T1D) and healthcare providers, to identify key areas for measuring health care transition outcomes, emphasizing the importance of stakeholder engagement in developing relevant measures.

The identified constructs for a new measure of health care transition outcomes include biomedical markers of T1D control, knowledge and skills related to T1D, and the ability to navigate the healthcare system, which will help in creating a comprehensive profile of transition success for young adults with T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Care Transition for Young Adults With Type 1 Diabetes: Stakeholder Engagement for Defining Optimal Outcomes. Pierce, JS., Aroian, K., Schifano, E., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transitioning from pediatric to adult care for patients with chronic diseases like type 1 diabetes is crucial for maintaining stable metabolic control and ensuring long-term health outcomes.

Factors such as social environment and other health conditions can complicate this transition, highlighting the need for tailored support and strategies to promote effective self-management of diabetes during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diabetes mellitus at the interface between pediatric and adult medicine]. Gallwitz, B., Neu, A.[2019]

This study evaluates a structured transition program for adolescents with Type 1 diabetes (T1D) to enhance their self-management and empowerment, involving 140 participants aged 16 from two pediatric diabetes clinics.

The effectiveness of this program will be assessed through various outcomes, including patient empowerment and diabetes management, over a period extending to 18.5 years, providing valuable insights into transitional care models for chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol. Brorsson, AL., Bratt, EL., Moons, P., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Adolescents and young adults with type 1 diabetes face significant health risks during their transition to adult health care, including poor glycemic control and increased emergency department visits, highlighting the need for effective transition strategies.

Qualitative research indicates that these patients benefit from a gradual transition process that includes support from healthcare providers and parents, as well as specific referrals to adult care, suggesting that structured transition models like navigator programs and joint visits can improve engagement in adult-oriented health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 diabetes: addressing the transition from pediatric to adult-oriented health care. Monaghan, M., Baumann, K.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40529395/

Study protocol for the SHIFT randomized clinical trial We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000742

Study protocol for the SHIFT randomized clinical trial A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for ...

3. diabetesjournals.org diabetesjournals.org/spectrum/article/35/1/57/139034/Opportunities-for-Enhanced-Transition-of-Care

Opportunities for Enhanced Transition of Care Preparation for ... Opportunities for enhanced transition of care preparation for adolescents and emerging adults with type 1 diabetes: use of the READDY transition tool.

4. drc.bmj.com drc.bmj.com/content/13/4/e004921

Transition and transfer experiences and their correlates in ... Experiences of transition to adulthood and transfer to adult care in young adults with type 1 diabetes: A qualitative study. J Adv Nurs 2023 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949923224000333

Development of a transition program for emerging adults ... A formal transition program can help prevent gaps in care, improve disease self-management skills, decrease disease burden, and reduce diabetes complications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4512132/

Evaluation of a Structured Transition Program for Young ... A structured transition program was successful in facilitating transition to adult care without a decrease in clinical follow-up.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10027053/

Development and Implementation of a Pilot Transition ... Young adults and parents participated in a 6-month intervention designed to enhance transition readiness and independent diabetes management.

8. withpower.com withpower.com/trial/phase-diabetes-mellitus-5-2023-1197b

Transition Care Program for Type 1 Diabetes (SHIFT2 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).