Autoimmune Diseases, Endocrine System Diseases, Immune System Diseases, Metabolic Disease, Type 1 Diabetes
Conditions
Keywords
self-management education, Hemaglobin A1c, Online education, adults, type 1 diabetes
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 (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.
Interventions
BEHAVIORALSupport 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.
Sponsors
Institut de Recherches Cliniques de Montreal
Centre Hospitalier de l'Universite Laval (CHUL)
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de médecine métabolique de Lanaudière
McGill University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for diabetes management | 0, 6 and 12 months | Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactAnne-Sophie Brazeau, PhD
Backup Contactamelie Roy-Fleming, MSc
Outcome results
None listed