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

McGill University

Status: Enrolling

Conditions: Type 1 Diabetes; Immune System Diseases; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases

Treatments: Behavioral: Support platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06069583

MP-02-2024-11714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 322 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of T1D (including LADA - latent autoimmune diabetes in adults)
• Have access to Internet
• Use of an active email address
• Comprehension of English or French
• Live in Canada

Exclusion criteria

- Unable to use the Support platform

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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322 participants in 2 patient groups

Support integrated in usual care

Experimental group

Description:

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.

Treatment:

Behavioral: Support platform

Support through independent access

Active Comparator group

Description:

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.

Treatment:

Behavioral: Support platform