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

NCT05434754 | Completed

• 1 other identifier: 3986
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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%.

  12 months

Secondary Outcomes (17)

• 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

• 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 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

Other Outcomes (4)

• Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages

  12 months

• Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with

  12 months

• Evaluation of intervention fidelity

  12 months

Study Arms (2)

eHealth Tool

EXPERIMENTAL

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.

Other: eHealth Tool

Control

NO INTERVENTION

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.

Interventions

eHealth Tool OTHER

text messaging algorithm

eHealth Tool

Eligibility Criteria

• Age: 17 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Trillium Health Partners: collaborator
• University Health Network, Toronto: collaborator

Study Sites (6)

Oak Valley Health

Markham, Ontario, L9P1S4, Canada

Location

Trillium Health Partners

Mississauga, Ontario, L5B2V2, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

McGill University Health Center

Montreal, Quebec, H3G1A4, Canada

Location

Saint Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 37156577 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 28, 2022
• Study Start: January 16, 2022
• Primary Completion: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)