Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300047
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-09
First Post:
2023-11-01
Brief Title:
Diabetes Transition Coordinator Study
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Aiming for Something Sweeter Supporting Youth With Type 1 Diabetes During Transition From Pediatric to Adult Diabetes Care
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie pediatric endocrinologist diabetes nurse or dietician and post-transfer with their adult diabetes team ie physician and as needed visits with a diabetes educator andor 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 participants 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 ie 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 ie TikTok Instagram and this will be considered during our pre-implementation phase The transition coordinator will not provide any medical advice or counselling
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 participants 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 ie 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 ie TikTok Instagram and this will be considered during our pre-implementation phase The transition coordinator will not provide any medical advice or counselling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None