- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05434754
Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care (KiT)
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 Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rayzel Shulman, MD, PhD
- Phone Number: 416-813-6218
- Email: rayzel.shulman@sickkids.ca
Study Contact Backup
- Name: Mikayla Sonnenberg
- Email: mikayla.sonnenberg@sickkids.ca
Study Locations
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Ontario
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Markham, Ontario, Canada, L9P1S4
- Recruiting
- Oak Valley Health
-
Contact:
- Alanna Landry
- Email: alandry@msh.on.ca
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Mississauga, Ontario, Canada, L5B2V2
- Recruiting
- Trillium Health Partners
-
Contact:
- Ian Zenlea, MD
- Email: ian.zenlea@thp.ca
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Ottawa, Ontario, Canada, K1H8L1
- Recruiting
- Children's Hospital of Eastern Ontario
-
Contact:
- Ellen Goldbloom, MD
- Email: egoldbloom@cheo.on.ca
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Toronto, Ontario, Canada, M5G1X8
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Geetha Sanmugalingham, MSc
- Email: geetha.sanmugalingham@sickkids.ca
-
Contact:
- Rayzel Shulman, MD/PhD
- Phone Number: 4168136218
- Email: rayzel.shulman@sickkids.ca
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Quebec
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Montréal, Quebec, Canada, H3G1A4
- Recruiting
- McGill University Health Center
-
Contact:
- Meranda Nakhla, MD
- Email: meranda.nakhla@mcgill.ca
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Montréal, Quebec, Canada, H3T1C5
- Not yet recruiting
- Saint Justine Hospital
-
Contact:
- Melanie Henderson, MD
- Email: melanie.henderson.hsj@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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text messaging algorithm
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 6 months
|
A secondary 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 measures (PROM) called the Self-Efficacy for Diabetes Management (SEDM) scale, measured at 6 months. 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%. |
6 months
|
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
Time Frame: Baseline
|
The Self-Efficacy for Diabetes Management (SEDM) scale will be used to measure diabetes self-efficacy at baseline. 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%. |
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
Time Frame: 12 months
|
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 12 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth.
The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills.
Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score 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
Time Frame: 6 months
|
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at 6 months; READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth.
The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills.
Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score 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
Time Frame: Baseline
|
• transition readiness measured by the Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) tool at baseline.
READDY is a transition readiness assessment for emerging adults with diabetes diagnosed in youth.
The READDY tool assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills.
Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1; confidence level is evaluated in each domain with a higher score indicating more confidence
|
Baseline
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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
Time Frame: 12 months
|
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale.
The scale ranges from "not at all true" (1) to "completely true" (5).
Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
|
12 months
|
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
Time Frame: 6 months
|
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale.
The scale ranges from "not at all true" (1) to "completely true" (5).
Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
|
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
Time Frame: baseline
|
• perceived stigma of living with T1D using the Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma Subscale; in our study, stigma will be defined as an affirmative response to at least one of three key items on this subscale.
The scale ranges from "not at all true" (1) to "completely true" (5).
Where a score greater than 2 to at least 1 of 3 key items indicates stigma.
|
baseline
|
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
Time Frame: 12 months
|
• A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
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12 months
|
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
Time Frame: 6 months
|
A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
|
6 months
|
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
Time Frame: baseline
|
A1c will be self-reported in the following categories of values: < 7%, 7 to < 8%, 8 to < 9%, >9% where higher percentage indicates poorer diabetes management
|
baseline
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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
Time Frame: 12 months
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
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12 months
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To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
Time Frame: baseline
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
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
Time Frame: 12 months
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
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
Time Frame: Baseline
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
Baseline
|
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes-related physician visits during the 12 months of intervention
Time Frame: 12 months
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
12 months
|
Number of diabetes-related physician visits at baseline for both intervention and control populations 24 months prior to describe baseline characteristics
Time Frame: Baseline
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
Baseline
|
Evaluate the impact of this text message-based intervention compared to usual care on number of diabetes drug and devices claims during the 12 months of intervention
Time Frame: 12 months
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 12 months of intervention.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
|
12 months
|
Number of diabetes drug and devices claims 24 months prior to enrolment to describe baseline characteristics
Time Frame: Baseline
|
• Health administrative data from ICES in Ontario and RAMQ in Quebec will be collected during the 24 months prior to enrolment.
ICES is an independent, not-for-profit research institute made up of a community of research, data and clinical experts in Ontario.
RAMQ manages, administers and publishes health data in the province of Quebec.
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Baseline
|
Evaluate the impact of this text message-based intervention costs compared to usual care costs
Time Frame: 12 months
|
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages
Time Frame: 12 months
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Embedded process evaluation using real-time engagement metrics with number of participants who are engaging with intervention messages on Concurrent process evaluation allows for real-time intervention modification to increase and improve user engagement and content delivery
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12 months
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Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with
Time Frame: 12 months
|
Embedded process evaluation using real-time engagement metrics looking at which types of messages are the most and least engaged with Concurrent process evaluation allows for real-time intervention modification to increase and improve user engagement and content delivery
|
12 months
|
Evaluation of intervention fidelity
Time Frame: 12 months
|
Embedded process evaluation using real-time engagement metrics (i.e.
number of participants who are engaging with intervention messages on and which types of messages are the most and least engaged with) Concurrent process evaluation allows for real-time intervention modification to increase and improve user engagement and content delivery
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12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3986 (OCTRI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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