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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06069583
• Other study ID #: MP-02-2024-11714
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: January 5, 2028

Study information

• Verified date: September 2023
• Source: McGill University
• Contact: Anne-Sophie Brazeau, PhD
• Phone: 5143987848
• Email: anne-sophie.brazeau[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 322
• Est. completion date: January 5, 2028
• Est. primary completion date: January 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endocrine System Diseases
• Immune System Diseases
• Metabolic Disease
• Metabolic Diseases
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
McGill University	Centre de médecine métabolique de Lanaudière, Centre hospitalier de l'Université de Montréal (CHUM), Centre Hospitalier de l'Université Laval, Institut de Recherches Cliniques de Montreal

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation question	Participants will be asked where they heard about the platform.	0 month
Other	communication with health care team	Question about type (in-person, phone, video call or email) and frequency of communication with health care team	0, 6 and 12 months
Other	Engagement with Support platform (T1D patient) - time in minutes on platform	Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform	6, 12 months
Other	Engagement with Support platform (T1D patient) - total pages viewed	Engagement metrics will be extracted using Google analytics - total pages viewed from the platform	6, 12 months
Other	Engagement with Support platform (T1D patient) - downloaded documents	Engagement metrics will be extracted using Google analytics - downloaded documents from the platform	6, 12 months
Other	Engagement with Support platform (T1D patient) - use of calculators	Engagement metrics will be extracted using Google analytics - use of calculators on the platform	6, 12 months
Other	Engagement with Support platform (Health Care Provider) - time in minutes on platform	Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform	6, 12 months
Other	Engagement with Support platform (Health Care Provider) - content accessed	Engagement metrics will be extracted using Google analytics - specific content accessed from the platform	6, 12 months
Other	Engagement with Support platform (Health Care Provider) - total pages viewed	Engagement metrics will be extracted using Google analytics - total pages viewed from the platform	6, 12 months
Other	Engagement with Support platform (Health Care Provider) - downloaded documents	Engagement metrics will be extracted using Google analytics - downloaded documents from the platform	6, 12 months
Other	Engagement with Support platform (Health Care Provider) - use of calculators	Engagement metrics will be extracted using Google analytics - use of calculators on the platform	6, 12 months
Other	Satisfaction with Support-t platform - T1D patient	Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.	6, 12 months
Other	Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient	Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology	12 months
Other	Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider	Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology	12 months
Primary	Self-efficacy for diabetes management	Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)	0, 6 and 12 months
Secondary	Well-being	WHO-5 well-being index	0, 6 and 12 months
Secondary	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.	0, 6 and 12 months
Secondary	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.	0, 6 and 12 months
Secondary	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.	0, 6 and 12 months
Secondary	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.	0, 6 and 12 months
Secondary	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.	0, 6 and 12 months
Secondary	Hemoglobin A1c	self-reported last Hemoglobin A1c (date and value) through online questionnaire	0, 6 and 12 months
Secondary	Severe hypoglycemic events	Self-reported severe hypoglycemic events in the past 6 months	0, 6 and 12 months
Secondary	Diabetic Ketoacidosis (DKA) events	Self-reported DKA events in the past 6 months	0, 6 and 12 months
Secondary	calls to 911	Self-reported number of calls to 911 in the past 6 months	0, 6 and 12 months
Secondary	calls to 811	Self-reported number of calls to 811 in the past 6 months	0, 6 and 12 months
Secondary	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	6 and 12 months
Secondary	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	6 and 12 months