Diabetes Transition Coordinator Study

Type 1 Diabetes Clinical Trial

Official title:

Aiming for Something Sweeter: Supporting Youth With Type 1 Diabetes During Transition From Pediatric to Adult Diabetes Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06300047
• Other study ID #: REB23-0679
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 324
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 18 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lost to Followup	% of participants who are lost to follow up as defined by not attending at least one routine clinic visit in adult diabetes care with a health care professional to be ascertained from physician billing claims or NACRS claims data	within 1 year of transfer date from pediatric care
Secondary	Patient Reported Outcome Survey 1	Problem Areas in Diabetes - Teen version Survey	within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Secondary	Patient Reported Outcome Survey 2	Diabetes Self-Efficacy Survey	within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Secondary	Patient Reported Outcome Survey 3	Diabetes Quality of Life for Youth Survey (short version)	within 2 months of transfer from pediatric care, repeated at 12 months after transfer
Secondary	Clinical Outcome 1	mean total number of clinic visits with any health care professional collected from NACRS claims data and physician claims data	one year prior to transfer from pediatric care up to 18 months post transfer
Secondary	Clinical Outcome 2	total number of diabetes related emergency department visits and hospitalizations for diabetic ketoacidosis	one year prior to transfer from pediatric care up to 18 months post transfer
Secondary	Clinical outcome 3	mean HbA1c	one year prior to transfer from pediatric care up to 18 months post transfer
Secondary	Clinical outcome 4	total number of HbA1c tests completed	one year prior to transfer from pediatric care up to 18 months post transfer
Secondary	Clinical Outcome 5	mean urinary albumin:creatinine ratio	one year prior to transfer from pediatric care up to 18 months post transfer
Secondary	Clinical Outcome 6	total number of urinary albumin:creatinine ratio tests completed	one year prior to transfer from pediatric care up to 18 months post transfer