Clinical trial NCT06300047: Diabetes Transition Coordinator Study
Official title: Aiming for Something Sweeter: Supporting Youth With Type 1 Diabetes During Transition From Pediatric to Adult Diabetes Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-03-08
Enrollment: 324
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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:

-

Primary outcomes:
measure: Lost to Followup
timeFrame: within 1 year of transfer date from pediatric care
Secondary outcomes:
measure: Patient Reported Outcome Survey 1
timeFrame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
measure: Patient Reported Outcome Survey 2
timeFrame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
measure: Patient Reported Outcome Survey 3
timeFrame: within 2 months of transfer from pediatric care, repeated at 12 months after transfer
measure: Clinical Outcome 1
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
measure: Clinical Outcome 2
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
measure: Clinical outcome 3
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
measure: Clinical outcome 4
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
measure: Clinical Outcome 5
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
measure: Clinical Outcome 6
timeFrame: one year prior to transfer from pediatric care up to 18 months post transfer
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sonia Butalia, MD
role: PRINCIPAL_INVESTIGATOR
References: