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

Sponsor

McGill University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06069583

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM) (Other), Institut de Recherches Cliniques de Montreal (Other), Centre Hospitalier de l'Université Laval (Other), Centre de médecine métabolique de Lanaudière (Other)

322

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Metabolic Disease Endocrine System Diseases Autoimmune Diseases Immune System Diseases	Behavioral: Support platform	N/A

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 (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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

322 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trialmixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jan 5, 2024

Anticipated Primary Completion Date :

Jan 5, 2027

Anticipated Study Completion Date :

Jan 5, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Support integrated in usual care 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 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.
Active Comparator: Support through independent access 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 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.

Arm

Intervention/Treatment

Experimental: Support integrated in usual care

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

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.

Active Comparator: Support through independent access

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

Outcome Measures

Primary Outcome Measures

Self-efficacy for diabetes management [0, 6 and 12 months]
Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)

Secondary Outcome Measures

Well-being [0, 6 and 12 months]
WHO-5 well-being index
Continuous Glucose Monitoring (CGM) - % Time in range [0, 6 and 12 months]
% 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.
Continuous Glucose Monitoring (CGM) - % Time above range [0, 6 and 12 months]
% 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.
Continuous Glucose Monitoring (CGM) - % Time below range [0, 6 and 12 months]
% 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.
Continuous Glucose Monitoring (CGM) - Standard deviation [0, 6 and 12 months]
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.
Continuous Glucose Monitoring (CGM) - % Coefficient of variation [0, 6 and 12 months]
% 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.
Hemoglobin A1c [0, 6 and 12 months]
self-reported last Hemoglobin A1c (date and value) through online questionnaire
Severe hypoglycemic events [0, 6 and 12 months]
Self-reported severe hypoglycemic events in the past 6 months
Diabetic Ketoacidosis (DKA) events [0, 6 and 12 months]
Self-reported DKA events in the past 6 months
calls to 911 [0, 6 and 12 months]
Self-reported number of calls to 911 in the past 6 months
calls to 811 [0, 6 and 12 months]
Self-reported number of calls to 811 in the past 6 months
Cost effectiveness (self-efficacy) [6 and 12 months]
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
Cost effectiveness (HbA1c) [6 and 12 months]
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

Other Outcome Measures

Implementation question [0 month]
Participants will be asked where they heard about the platform.
communication with health care team [0, 6 and 12 months]
Question about type (in-person, phone, video call or email) and frequency of communication with health care team
Engagement with Support platform (T1D patient) - time in minutes on platform [6, 12 months]
Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
Engagement with Support platform (T1D patient) - total pages viewed [6, 12 months]
Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
Engagement with Support platform (T1D patient) - downloaded documents [6, 12 months]
Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
Engagement with Support platform (T1D patient) - use of calculators [6, 12 months]
Engagement metrics will be extracted using Google analytics - use of calculators on the platform
Engagement with Support platform (Health Care Provider) - time in minutes on platform [6, 12 months]
Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
Engagement with Support platform (Health Care Provider) - content accessed [6, 12 months]
Engagement metrics will be extracted using Google analytics - specific content accessed from the platform
Engagement with Support platform (Health Care Provider) - total pages viewed [6, 12 months]
Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
Engagement with Support platform (Health Care Provider) - downloaded documents [6, 12 months]
Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
Engagement with Support platform (Health Care Provider) - use of calculators [6, 12 months]
Engagement metrics will be extracted using Google analytics - use of calculators on the platform
Satisfaction with Support-t platform - T1D patient [6, 12 months]
Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.
Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient [12 months]
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider [12 months]
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology