Implementation of Support in the Care of Adults Living With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Support platform.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- 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 the
Primary outcome measures
- Self-efficacy for diabetes management [Time frame: 0, 6 and 12 months]
Secondary outcome measures (12)
- Well-being [Time frame: 0, 6 and 12 months]
- Continuous Glucose Monitoring (CGM) - % Time in range [Time frame: 0, 6 and 12 months]
- Continuous Glucose Monitoring (CGM) - % Time above range [Time frame: 0, 6 and 12 months]
- Continuous Glucose Monitoring (CGM) - % Time below range [Time frame: 0, 6 and 12 months]
- Continuous Glucose Monitoring (CGM) - Standard deviation [Time frame: 0, 6 and 12 months]
- Continuous Glucose Monitoring (CGM) - % Coefficient of variation [Time frame: 0, 6 and 12 months]
- Hemoglobin A1c [Time frame: 0, 6 and 12 months]
- Severe hypoglycemic events [Time frame: 0, 6 and 12 months]
- Diabetic Ketoacidosis (DKA) events [Time frame: 0, 6 and 12 months]
- calls to 911 [Time frame: 0, 6 and 12 months]
- calls to 811 [Time frame: 0, 6 and 12 months]
- Cost effectiveness (self-efficacy) [Time frame: 6 and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Canada · 4 centers
- Institut de recherches cliniques de Montréal — Montreal
- Centre hospitalier de l'université de Montreal — Montreal
- Centre hospitalier de Quebec, Université Laval — Québec
- Centre de médecine métabolique de Lanaudière — Terrebonne
Publications
- Xie LF, Roy-Fleming A, Haag S, Costa DD, Brazeau AS. Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. Digit Health. 2023 Jan 24;9:20552076231152760. doi: 10.1177/20552076231152760. eCollection 2023 Jan-Dec. PMID 36762025
- Xie LF, Itzkovitz A, Roy-Fleming A, Da Costa D, Brazeau AS. Understanding Self-Guided Web-Based Educational Interventions for Patients With Chronic Health Conditions: Systematic Review of Intervention Features and Adherence. J Med Internet Res. 2020 Aug 13;22(8):e18355. doi: 10.2196/18355. PMID 32788152
- Kruger J, Brennan A, Thokala P, Basarir H, Jacques R, Elliott J, Heller S, Speight J. The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. Diabet Med. 2013 Oct;30(10):1236-44. doi: 10.1111/dme.12270. Epub 2013 Aug 19. PMID 23815547
- Stanton-Fay SH, Hamilton K, Chadwick PM, Lorencatto F, Gianfrancesco C, de Zoysa N, Coates E, Cooke D, McBain H, Heller SR, Michie S; DAFNEplus study group. The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. Diabet Med. 2021 May;38(5):e14548. doi: 10.1111/dme.14548. Epub 2021 Mar 10. PMID 33617669
- Pereira K, Phillips B, Johnson C, Vorderstrasse A. Internet delivered diabetes self-management education: a review. Diabetes Technol Ther. 2015 Jan;17(1):55-63. doi: 10.1089/dia.2014.0155. PMID 25238257
- Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
- Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies. Front Clin Diabetes Healthc. 2022 Jan 13;2:823046. doi: 10.3389/fcdhc.2021.823046. eCollection 2021. PMID 36994332
Identifiers
NCT: NCT06069583 · MP-02-2024-11714