Clinical trial NCT05434754: Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Trillium Health Partners
name: University Health Network, Toronto
First posted: 2022-06-28
Enrollment: 234
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 1 diabetes, ascertained from patient's medical chart
2. Receiving out-patient care for T1D at a pediatric diabetes center participating in this study
3. 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
4. Proficient in written and spoken English or French
5. Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
6. Valid and working mobile phone number
7. Valid email address
8. Willing to engage with intervention if randomized to intervention arm
9. 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
10. Willing to provide informed consent

Exclusion Criteria:

1. Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening
2. Non-resident of Ontario or Quebec
3. 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
4. Currently enrolled in any other clinical research trial with an SMS-based intervention
5. Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
timeFrame: Baseline
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: baseline
measure: Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
timeFrame: 12 months
measure: Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
timeFrame: 6 months
measure: To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
timeFrame: baseline
measure: 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
timeFrame: 12 months
measure: To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
timeFrame: baseline
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: Baseline
measure: Evaluate the impact of this text message-based intervention costs compared to usual care costs
timeFrame: 12 months
measure: Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting.
timeFrame: 12 months
Other outcomes:
measure: Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages
timeFrame: 12 months
measure: Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with
timeFrame: 12 months
measure: Evaluation of intervention fidelity
timeFrame: 12 months
measure: Identify the different paths of engagement (i.e., combinations of KiT components) that produce a positive effect on trial outcomes). Specifically from when the chatbot was incorporated in September 2024.
timeFrame: 12 months.
Locations:
city: Markham
country: Canada
facility: Oak Valley Health
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Montréal
country: Canada
facility: Saint Justine Hospital
state: Quebec
Study officials:
References: