Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care

The Hospital for Sick Children

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: eHealth Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05434754

3986 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 17 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

eHealth Tool

Experimental group

Description:

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.

Treatment:

Other: eHealth Tool

Control

No Intervention group

Description:

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.