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

Primary Purpose

Type 1 Diabetes, Metabolic Disease, Endocrine System Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Support platform
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring self-management education, Hemaglobin A1c, Online education, adults, type 1 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Support integrated in usual care

    Support through independent access

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Self-efficacy for diabetes management
    Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)

    Secondary Outcome Measures

    Well-being
    WHO-5 well-being index
    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.
    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.
    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.
    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.
    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.
    Hemoglobin A1c
    self-reported last Hemoglobin A1c (date and value) through online questionnaire
    Severe hypoglycemic events
    Self-reported severe hypoglycemic events in the past 6 months
    Diabetic Ketoacidosis (DKA) events
    Self-reported DKA events in the past 6 months
    calls to 911
    Self-reported number of calls to 911 in the past 6 months
    calls to 811
    Self-reported number of calls to 811 in the past 6 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
    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

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    September 29, 2023
    Sponsor
    McGill University
    Collaborators
    Centre hospitalier de l'Université de Montréal (CHUM), Institut de Recherches Cliniques de Montreal, Centre Hospitalier de l'Université Laval, Centre de médecine métabolique de Lanaudière
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069583
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 5, 2024 (Anticipated)
    Primary Completion Date
    January 5, 2027 (Anticipated)
    Study Completion Date
    January 5, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McGill University
    Collaborators
    Centre hospitalier de l'Université de Montréal (CHUM), Institut de Recherches Cliniques de Montreal, Centre Hospitalier de l'Université Laval, Centre de médecine métabolique de Lanaudière

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    322 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Support integrated in usual care
    Arm Type
    Experimental
    Arm Description
    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 Title
    Support through independent access
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Support platform
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Self-efficacy for diabetes management
    Description
    Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)
    Time Frame
    0, 6 and 12 months
    Secondary Outcome Measure Information:
    Title
    Well-being
    Description
    WHO-5 well-being index
    Time Frame
    0, 6 and 12 months
    Title
    Continuous Glucose Monitoring (CGM) - % Time in range
    Description
    % 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.
    Time Frame
    0, 6 and 12 months
    Title
    Continuous Glucose Monitoring (CGM) - % Time above range
    Description
    % 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.
    Time Frame
    0, 6 and 12 months
    Title
    Continuous Glucose Monitoring (CGM) - % Time below range
    Description
    % 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.
    Time Frame
    0, 6 and 12 months
    Title
    Continuous Glucose Monitoring (CGM) - Standard deviation
    Description
    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.
    Time Frame
    0, 6 and 12 months
    Title
    Continuous Glucose Monitoring (CGM) - % Coefficient of variation
    Description
    % 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.
    Time Frame
    0, 6 and 12 months
    Title
    Hemoglobin A1c
    Description
    self-reported last Hemoglobin A1c (date and value) through online questionnaire
    Time Frame
    0, 6 and 12 months
    Title
    Severe hypoglycemic events
    Description
    Self-reported severe hypoglycemic events in the past 6 months
    Time Frame
    0, 6 and 12 months
    Title
    Diabetic Ketoacidosis (DKA) events
    Description
    Self-reported DKA events in the past 6 months
    Time Frame
    0, 6 and 12 months
    Title
    calls to 911
    Description
    Self-reported number of calls to 911 in the past 6 months
    Time Frame
    0, 6 and 12 months
    Title
    calls to 811
    Description
    Self-reported number of calls to 811 in the past 6 months
    Time Frame
    0, 6 and 12 months
    Title
    Cost effectiveness (self-efficacy)
    Description
    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
    Time Frame
    6 and 12 months
    Title
    Cost effectiveness (HbA1c)
    Description
    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
    Time Frame
    6 and 12 months
    Other Pre-specified Outcome Measures:
    Title
    Implementation question
    Description
    Participants will be asked where they heard about the platform.
    Time Frame
    0 month
    Title
    communication with health care team
    Description
    Question about type (in-person, phone, video call or email) and frequency of communication with health care team
    Time Frame
    0, 6 and 12 months
    Title
    Engagement with Support platform (T1D patient) - time in minutes on platform
    Description
    Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (T1D patient) - total pages viewed
    Description
    Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (T1D patient) - downloaded documents
    Description
    Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (T1D patient) - use of calculators
    Description
    Engagement metrics will be extracted using Google analytics - use of calculators on the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (Health Care Provider) - time in minutes on platform
    Description
    Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (Health Care Provider) - content accessed
    Description
    Engagement metrics will be extracted using Google analytics - specific content accessed from the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (Health Care Provider) - total pages viewed
    Description
    Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (Health Care Provider) - downloaded documents
    Description
    Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
    Time Frame
    6, 12 months
    Title
    Engagement with Support platform (Health Care Provider) - use of calculators
    Description
    Engagement metrics will be extracted using Google analytics - use of calculators on the platform
    Time Frame
    6, 12 months
    Title
    Satisfaction with Support-t platform - T1D patient
    Description
    Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.
    Time Frame
    6, 12 months
    Title
    Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient
    Description
    Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
    Time Frame
    12 months
    Title
    Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider
    Description
    Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne-Sophie Brazeau, PhD
    Phone
    5143987848
    Email
    anne-sophie.brazeau@mcgill.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    amelie Roy-Fleming, MSc
    Phone
    5147790749
    Email
    amelie.roy-fleming@mcgill.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne-Sophie Brazeau, PhD
    Organizational Affiliation
    School of human nutrition - McGill University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36762025
    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.
    Results Reference
    background
    PubMed Identifier
    32788152
    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.
    Results Reference
    background
    PubMed Identifier
    23815547
    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.
    Results Reference
    background
    PubMed Identifier
    33617669
    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.
    Results Reference
    background
    PubMed Identifier
    25238257
    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.
    Results Reference
    background
    PubMed Identifier
    22310560
    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.
    Results Reference
    background
    PubMed Identifier
    36994332
    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.
    Results Reference
    background

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

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