Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care: a Randomized Control Trial Testing the Effectiveness of an eHealth Text Message-based Intervention to Improve Diabetes Self-efficacy
Overview
- Phase
- N/A
- Intervention
- eHealth Tool
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 234
- Locations
- 12
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 3 days ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rayzel Shulman
Principal Investigator
The Hospital for Sick Children
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with type 1 diabetes, ascertained from patient's medical chart
- •Receiving out-patient care for T1D at a pediatric diabetes center participating in this study
- •Is within 6 months of either planned transfer or 18th birthday so research coordinator can approach patient and inform them about the study, and then can be re-approached for consenting and enrollment only within 3-4 months of either: planned transfer to adult diabetes care OR 18th birthday
- •Proficient in written and spoken English or French
- •Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
- •Valid and working mobile phone number
- •Valid email address
- •Willing to engage with intervention if randomized to intervention arm
- •Willing to complete study outcome measures (questionnaires) at all study time-points regardless of which arm they are randomized to: baseline, 6 months, and 12 months
- •Willing to provide informed consent
Exclusion Criteria
- •Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening
- •Non-resident of Ontario or Quebec
- •Planning to move out of either province in the next 6-12 months and after moving, will not be receiving diabetes care in either province and/or will not have a valid and working mobile number
- •Currently enrolled in any other clinical research trial with an SMS-based intervention
- •Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit
Arms & Interventions
eHealth Tool
The Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question \& Answer feature.
Intervention: eHealth Tool
Control
Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care.
Outcomes
Primary Outcomes
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.
Time Frame: 12 months
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%.
Secondary Outcomes
- 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.(6 months)
- Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c(6 months)
- To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.(Baseline)
- 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(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(baseline)
- 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(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(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(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(12 months)
- Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values(12 months)
- To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c(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(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(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(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(Baseline)
- Evaluate the impact of this text message-based intervention costs compared to usual care costs(12 months)
- Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting.(12 months)