Implementation of Support in the Care of Adults Living With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 (i.e., 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 (i.e., 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. ;

Related Conditions & MeSH terms

• Autoimmune Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endocrine System Diseases
• Immune System Diseases
• Metabolic Disease
• Metabolic Diseases
• Type 1 Diabetes

• NCT number: NCT06069583
• Study type: Interventional
• Source: McGill University
• Contact: Anne-Sophie Brazeau, PhD
• Phone: 5143987848
• Email: anne-sophie.brazeau@mcgill.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 5, 2024
• Completion date: January 5, 2028