Diabetes Transition Coordinator Study

NCT ID: NCT06300047

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-12-31

Brief Summary

The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.

The 3 main aims are:

1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.

2. To implement the transition intervention and evaluate the implementation outcomes.

3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.

Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention.

Detailed Description

Both usual care and intervention groups will receive routine diabetes care as per Canadian national guidelines. Usual care (routine care) includes regular appointments with their pediatric diabetes care team (i.e., pediatric endocrinologist, diabetes nurse or dietician) and post-transfer with their adult diabetes team (i.e., physician and as needed visits with a diabetes educator and/or a dietician). The transition process usually starts at age 14 with discussions during clinic with youth and families around increased autonomy, self-care, organization of adult healthcare services and specific transition topics such as driving, drugs, alcohol, relationships, finances and living away from home.

The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention.

The intervention group (in addition to usual care) is provided additional support by way of a non-medical transition coordinator during the transition and transfer from pediatric to adult diabetes care. The non-medical transition coordinator encourages problem solving, self-management skills, and supports navigating the 'adult world'. In the year prior to transfer, the transition coordinator will meet each participant in person or virtually once during their routine pediatric diabetes appointment to explain their role prior to transfer. The transition coordinator role includes the following tasks: (1) use of text messaging, email, or phone communication (as per participant's preference) to maintain contact with the participant every 2 months for 12 months past the transfer date; (2) use of text messaging, email, or telephone as needed when participants reach out to them to answer any questions whereby the transition coordinator would provide direction; (3) assisting participants with finding family physicians (if needed); (4) assisting with completion of financial assistance, disability, insurance forms; (4) addressing any stated psychosocial needs by relaying information on community supports for participants and families; and, (5) maintaining a private Facebook® page and a transition website in which participants were encouraged to use. Website contents include information on transition, adult diabetes care (i.e., location, contact numbers, what to expect in adult care), diabetes resources as well as mental health resources. The website will be updated to have information relevant to each implementation site. We may add other types of social media to share information about transition (i.e., TikTok, Instagram), and this will be considered during our pre-implementation phase. The transition coordinator will not provide any medical advice or counselling.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care Group

No intervention group used as a control leading into the intervention for comparative analysis. Patients in this arm receive care as usual with no changes and are not aware of the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Patients in this arm receive access to and support from a Transition coordinator who will meet with them prior to transition from pediatric to adult care and follow up with them every 2 months throughout the first year of their transition period utilizing phone, text, email, social media.

Group Type: EXPERIMENTAL

Non-Medical Transition Coordinator

Intervention Type: OTHER

Participants in this intervention arm will have access to the non-medical transition coordinator to support their transition from pediatric to adult care.

Interventions

Non-Medical Transition Coordinator

Participants in this intervention arm will have access to the non-medical transition coordinator to support their transition from pediatric to adult care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• a diagnosis of T1D according to Diabetes Canada's guidelines for at least 12 months
• aged 17 to 18 years
• have had an appointment with their pediatric endocrinologist in the last 12 months
• in the last year of pediatric care and transferring to adult care in Alberta within the next year
• English proficiency (for surveys)
• Personal Health Number (PHN) for data linkage.

Exclusion Criteria

-

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Butalia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB23-0679

Identifier Type: -

Identifier Source: org_study_id