The investigators are testing the effectiveness of an eHealth digital tool co-designed with patients and providers to improve diabetes self-efficacy in young adults as they transition to adult type 1 diabetes care.
The intervention is an eHealth digital solution co-designed with patients and providers. The intervention is a text message based algorithm that operates similar to a chatbot and will send SMS messages to participants in the experimental arm, consisting of T1D personalized support, education, resources, and a collection of outcome measures. Participants in the control arm will also be onboarded to the KiT algorithm but will only receive text-messages asking them to complete outcome measures at baseline, 6 and 12 months -- all outcome measures will be URL linkouts to REDCap surveys, housed on the SickKids REDCap servers. An embedded process evaluation of high and low engagers will also be conducted to understand how and why the intervention achieved or failed to achieve the desired effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
234
text messaging algorithm
Oak Valley Health
Markham, Ontario, Canada
Trillium Health Partners
Mississauga, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy.
The primary objective of this study is to compare the effectiveness of a text message-based T1D transition intervention that will personalize transition education and support, as an adjunct to usual T1D transition care versus usual transition care alone on a patient-reported outcome measure (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 12 months after enrollment in the study. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes. Minimal clinically important difference is 10%.
Time frame: 12 months
Compare text message-based T1D transition intervention to control at 6 months in the Self-Efficacy for Diabetes management scale. Higher score indicates better self efficacy.
A secondary objective of this study is to compare the effectiveness of a text message-based T1D transition intervention that will personalize transition education and support, as an adjunct to usual T1D transition care versus usual transition care alone on a patient-reported outcome measures (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 6 months. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes. Minimal clinically important difference is 10%.
Time frame: 6 months
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
The Self-Efficacy for Diabetes Management (SEDM) scale will be used to measure diabetes self-efficacy at baseline. The SEDM has scale from 1-10 where 1 denotes 'not at all sure' and 10 denotes 'completely sure' where higher scores mean better outcomes. Minimal clinically important difference is 10%.
Time frame: Baseline
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McGill University Health Center
Montreal, Quebec, Canada
Saint Justine Hospital
Montreal, Quebec, Canada
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 12 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 6 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Time frame: 6 months
To compare transition readiness in the intervention and control groups at baseline using the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) Tool. Higher scores indicating more confidence
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at baseline. READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth. The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
Time frame: Baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Time frame: 6 months
To compared perceived stigma of living with T1D between the intervention and control groups at baseline using the self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale. The scale ranges from "not at all true" (1) to "completely true" (5). Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
• A1c will be self-reported in the following categories of values: \< 7%, 7 to \< 8%, 8 to \< 9%, \>9% where higher percentage indicates poorer diabetes management
Time frame: 12 months
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
A1c will be self-reported in the following categories of values: \< 7%, 7 to \< 8%, 8 to \< 9%, \>9% where higher percentage indicates poorer diabetes management
Time frame: 6 months
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
A1c will be self-reported in the following categories of values: \< 7%, 7 to \< 8%, 8 to \< 9%, \>9% where higher percentage indicates poorer diabetes management
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related ED visits during the 12 months of intervention
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Time frame: 12 months
To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Time frame: baseline
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related hospitalizations and length of diabetes-related hospitalizations during the 12 months of intervention
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Time frame: 12 months
Number of diabetes-related hospitalizations and length of diabetes-related hospitalizations 24 months prior to intervention for both intervention and control populations to describe baseline characteristics
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment. ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario. RAMQ manages, administers and publishes health data in the province of Quebec.
Time frame: Baseline
Evaluate the impact of this text message-based intervention costs compared to usual care costs
* Costs of implementation will be collected to ascertain the cost of developing and using this intervention in a hospital setting in Ontario and Quebec; variables that will be collected for this analysis will include: salaries for staff working on the design, development and management of the intervention for the entire intervention duration; salary of research coordinators working to onboard participants to the intervention; cost of digital services and office equipment needed to develop and manage the intervention (computers, hosting service, servers); cost of REDcap servers and hospital IT support for REDCap integration with MEMOTEXT platform * Aggregate and direct medical costs associated with the intervention and its implementation will be measured for the 12 months of the intervention duration using study and administrative data
Time frame: 12 months
Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting.
* Analyses for the preliminary safety and performance KiT LLM chatbot testing will include descriptively describing whether the LLM Evaluator acts more conservatively than human raters when scoring answers, and if the answers generated by KiT LLM are acceptable based on the graded criteria. * After the trial is completed, the investigators will analyze conversation logs between participants and KiT LLM to derive effective engagement with the bot. This will include analyzing the conversation between participants and KiT LLM (eg, duration, breadth, and depth of bot usage). * The performance of the LLM Evaluator will also be assessed by evaluating conversations flagged and any potentially sensitive conversations missed. This evaluation will provide insights into how KiT LLM was used in a real-world setting and opportunities to improve its performance over time.
Time frame: 12 months