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

NCT ID: NCT05434754

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-16
• Study Completion Date: 2025-09-30

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

eHealth Tool

Intervention Type: OTHER

text messaging algorithm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eHealth Tool

text messaging algorithm

Intervention Type: OTHER

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trillium Health Partners

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Rayzel Shulman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

McGill University Health Center

Montreal, Quebec, Canada

Saint Justine Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Sanmugalingham G, Mok E, Cafazzo JA, Desveaux L, Brazeau AS, Booth GL, Greenberg M, Kichler J, Rac VE, Austin P, Goldbloom E, Henderson M, Landry A, Zenlea I, Taylor M, Nakhla M, Shulman R. Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial. BMJ Open. 2023 May 8;13(5):e071396. doi: 10.1136/bmjopen-2022-071396.

Reference Type: DERIVED

PMID: 37156577 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

3986

Identifier Type: -

Identifier Source: org_study_id