Clinical trial NCT06069583: Implementation of Support in the Care of Adults Living With Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Metabolic Disease
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Keywords: self-management education
Hemaglobin A1c
Online education
adults
type 1 diabetes
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Institut de Recherches Cliniques de Montreal
name: Centre Hospitalier de l'Université Laval
name: Centre de médecine métabolique de Lanaudière
First posted: 2023-10-06
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Self-efficacy for diabetes management
timeFrame: 0, 6 and 12 months
Secondary outcomes:
measure: Well-being
timeFrame: 0, 6 and 12 months
measure: Continuous Glucose Monitoring (CGM) - % Time in range
timeFrame: 0, 6 and 12 months
measure: Continuous Glucose Monitoring (CGM) - % Time above range
timeFrame: 0, 6 and 12 months
measure: Continuous Glucose Monitoring (CGM) - % Time below range
timeFrame: 0, 6 and 12 months
measure: Continuous Glucose Monitoring (CGM) - Standard deviation
timeFrame: 0, 6 and 12 months
measure: Continuous Glucose Monitoring (CGM) - % Coefficient of variation
timeFrame: 0, 6 and 12 months
measure: Hemoglobin A1c
timeFrame: 0, 6 and 12 months
measure: Severe hypoglycemic events
timeFrame: 0, 6 and 12 months
measure: Diabetic Ketoacidosis (DKA) events
timeFrame: 0, 6 and 12 months
measure: calls to 911
timeFrame: 0, 6 and 12 months
measure: calls to 811
timeFrame: 0, 6 and 12 months
measure: Cost effectiveness (self-efficacy)
timeFrame: 6 and 12 months
measure: Cost effectiveness (HbA1c)
timeFrame: 6 and 12 months
Other outcomes:
measure: Implementation question
timeFrame: 0 month
measure: communication with health care team
timeFrame: 0, 6 and 12 months
measure: Engagement with Support platform (T1D patient) - time in minutes on platform
timeFrame: 6, 12 months
measure: Engagement with Support platform (T1D patient) - total pages viewed
timeFrame: 6, 12 months
measure: Engagement with Support platform (T1D patient) - downloaded documents
timeFrame: 6, 12 months
measure: Engagement with Support platform (T1D patient) - use of calculators
timeFrame: 6, 12 months
measure: Engagement with Support platform (Health Care Provider) - time in minutes on platform
timeFrame: 6, 12 months
measure: Engagement with Support platform (Health Care Provider) - content accessed
timeFrame: 6, 12 months
measure: Engagement with Support platform (Health Care Provider) - total pages viewed
timeFrame: 6, 12 months
measure: Engagement with Support platform (Health Care Provider) - downloaded documents
timeFrame: 6, 12 months
measure: Engagement with Support platform (Health Care Provider) - use of calculators
timeFrame: 6, 12 months
measure: Satisfaction with Support-t platform - T1D patient
timeFrame: 6, 12 months
measure: Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient
timeFrame: 12 months
measure: Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider
timeFrame: 12 months
Locations:
Study officials:
affiliation: School of human nutrition - McGill University
name: Anne-Sophie Brazeau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.