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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metabolic Disease, Endocrine System Diseases, Type 1 Diabetes, Autoimmune Diseases, Immune System Diseases

Intervention / Treatment
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* Behavioral: Support platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Support integrated in usual care<br>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. | Behavioral: Support platform<br>* The study will be conducted over a 12-month period. This should allow participants to see their medical team 2 to 3 times during this timeframe. Participants of arms 1 and 2 will have access to the Support platform and will receive a monthly newsletter, informing them of news on the platform and acting as a reminder to log in. Several features are included in this responsive-designed platform to enhance participation, such as a visual of personal progress, ability to bookmark content, change their avatar. Support contains 3 main components: Educational material, News blog written by HCPs weekly in collaboration with patient-partners on up-to-date topics related to T1D, a peer-to-peer discussion forum which is moderated daily by a HCP specializing in T1D.<br>|
| Active Comparator: Support through independent access<br>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. | Behavioral: Support platform<br>* The study will be conducted over a 12-month period. This should allow participants to see their medical team 2 to 3 times during this timeframe. Participants of arms 1 and 2 will have access to the Support platform and will receive a monthly newsletter, informing them of news on the platform and acting as a reminder to log in. Several features are included in this responsive-designed platform to enhance participation, such as a visual of personal progress, ability to bookmark content, change their avatar. Support contains 3 main components: Educational material, News blog written by HCPs weekly in collaboration with patient-partners on up-to-date topics related to T1D, a peer-to-peer discussion forum which is moderated daily by a HCP specializing in T1D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for diabetes management | Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10) | 0, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | WHO-5 well-being index | 0, 6 and 12 months | 
| Continuous Glucose Monitoring (CGM) - % Time in range | % Time in range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap. | 0, 6 and 12 months | 
| Continuous Glucose Monitoring (CGM) - % Time above range | % Time above range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap. | 0, 6 and 12 months | 
| Continuous Glucose Monitoring (CGM) - % Time below range | % Time below range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap. | 0, 6 and 12 months | 
| Continuous Glucose Monitoring (CGM) - Standard deviation | Standard deviation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap. | 0, 6 and 12 months | 
| Continuous Glucose Monitoring (CGM) - % Coefficient of variation | % Coefficient of variation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap. | 0, 6 and 12 months | 
| Hemoglobin A1c | self-reported last Hemoglobin A1c (date and value) through online questionnaire | 0, 6 and 12 months | 
| Severe hypoglycemic events | Self-reported severe hypoglycemic events in the past 6 months | 0, 6 and 12 months | 
| Diabetic Ketoacidosis (DKA) events | Self-reported DKA events in the past 6 months | 0, 6 and 12 months | 
| calls to 911 | Self-reported number of calls to 911 in the past 6 months | 0, 6 and 12 months | 
| calls to 811 | Self-reported number of calls to 811 in the past 6 months | 0, 6 and 12 months | 
| Cost effectiveness (self-efficacy) | Cost effectiveness of access to Support as part of usual care compared with independent access in terms of incremental cost effectiveness ratio (ICER) for self-efficacy | 6 and 12 months | 
| Cost effectiveness (HbA1c) | Cost effectiveness of access to Support as part of usual care compared with independent access in terms of incremental cost effectiveness ratio (ICER) for HbA1c | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online education, adults, type 1 diabetes, self-management education, Hemaglobin A1c