Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-29
Brief Title:
Implementation of Support in the Care of Adults Living With Type 1 Diabetes
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Using the Support Online Platform for Self-management Education of Adults Living With Type 1 Diabetes as Part of Usual Care or Independently an Implementation Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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 investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes T1D in their diabetes self-management Investigators will compare a group that has access to the Support platform through their usual medical care to a group that accesses the platform independently The first group will be recruited through four participating clinics in the province of Quebec Canada The second group will be composed of adults living with T1D across Canada Participants will have access to the platform for 12 months and will be asked to complete online questionnaires at the beginning and after 6 and 12 months and share their glucose reader data with the research team A subgroup of participants as well as healthcare professionals from the four clinics will be invited to participate in an individual interview aiming to understand the barriers and facilitators of integration Support in clinical care
Detailed Description:
Type 1 diabetes T1D is a chronic condition which requires life-sustaining insulin therapy as well as knowledge skills and confidence to self-manage Tailored diabetes self-management education DSME should be offered to all people living with diabetes PWT1D at diagnosis but also in a timely manner according to needs DSME has the potential to improve quality of life and decrease diabetes complications Despite the positive outcomes of other DSME programs participation rates of DSME vary greatly perhaps because access remains sub-optimal Also healthcare professionals HCPs face a challenge to remain aware of the particularities of T1D and stay up-to-date on the rapidly evolving evidence-based knowledge technologies and therapies available The investigators propose to examine an online training and peer support platform called Support as a potential alternative for DSME
The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the Support platform to routine medical care of adults living with T1D ie diabetes team referring to the Support platform during appointments can improve diabetes self- management in comparison with navigating the Support platform independently of usual care ie the platform not being discussed during appointment Effectiveness and to study the factors affecting its implementation in real-life settings Implementation
This study is a mixed-method multi-site 2 arms non-randomized type 1 hybrid effectiveness-implementation trial
ARM 1 PWT1D participants will have access to Support as part of their regular care their HCPs will use Support in their care PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid
ARM 2 PWT1D participants will have access to Support independently from their regular care they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform but will not prompt to any specific section on the platform and will not receive any training about the platform PWT1D participants in ARM 2 can be followed in any other clinics in Canada
Implementation data will be gathered through HCP participants in the participating clinics
Participants will have to answer online surveys at baseline 6 months and 12 months After completing the baseline questionnaire they will receive an access to the platform A subgroup of participants as well as participating HCPs will be invited for individual interviews to discuss their experience in using the platform
The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the Support platform to routine medical care of adults living with T1D ie diabetes team referring to the Support platform during appointments can improve diabetes self- management in comparison with navigating the Support platform independently of usual care ie the platform not being discussed during appointment Effectiveness and to study the factors affecting its implementation in real-life settings Implementation
This study is a mixed-method multi-site 2 arms non-randomized type 1 hybrid effectiveness-implementation trial
ARM 1 PWT1D participants will have access to Support as part of their regular care their HCPs will use Support in their care PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid
ARM 2 PWT1D participants will have access to Support independently from their regular care they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform but will not prompt to any specific section on the platform and will not receive any training about the platform PWT1D participants in ARM 2 can be followed in any other clinics in Canada
Implementation data will be gathered through HCP participants in the participating clinics
Participants will have to answer online surveys at baseline 6 months and 12 months After completing the baseline questionnaire they will receive an access to the platform A subgroup of participants as well as participating HCPs will be invited for individual interviews to discuss their experience in using the platform
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