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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
eHealth Tool
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 1

Eligibility Criteria

17 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Oak Valley HealthRecruiting
  • Trillium Health PartnersRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • McGill University Health CenterRecruiting
  • Saint Justine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eHealth Tool

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.
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%.
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
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%.
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
• 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
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
• 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
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
• 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
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
• 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.
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
• 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.
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
• 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.
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
• 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
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
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
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
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
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
• 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.
To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at 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.
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
• 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.
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
• 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.
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
• 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.
Number of diabetes-related physician visits at baseline for both intervention and control populations 24 months prior to describe baseline characteristics
• 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.
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
• 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.
Number of diabetes drug and devices claims 24 months prior to enrolment to describe baseline characteristics
• 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.
Evaluate the impact of this text message-based intervention costs compared to usual care costs
Costs of implementation will be collected to ascertain the cost of developing and using this intervention in a hospital setting in Ontario and Quebec; variables that will be collected for this analysis will include: salaries for staff working on the design, development and management of the intervention for the entire intervention duration; salary of research coordinators working to onboard participants to the intervention; cost of digital services and office equipment needed to develop and manage the intervention (computers, hosting service, servers); cost of REDcap servers and hospital IT support for REDCap integration with MEMOTEXT platform Aggregate and direct medical costs associated with the intervention and its implementation will be measured for the 12 months of the intervention duration using study and administrative data

Full Information

First Posted
May 29, 2022
Last Updated
August 9, 2023
Sponsor
The Hospital for Sick Children
Collaborators
Trillium Health Partners, University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05434754
Brief Title
Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care
Acronym
KiT
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Trillium Health Partners, University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eHealth Tool
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
eHealth Tool
Intervention Description
text messaging algorithm
Primary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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.
Description
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%.
Time Frame
6 months
Title
To compare diabetes self-efficacy in the intervention vs. control group at baseline. A higher score indicates better self efficacy.
Description
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%.
Time Frame
Baseline
Title
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
Description
• 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
Time Frame
12 months
Title
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
Description
• 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
Time Frame
6 months
Title
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
Description
• 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
Time Frame
Baseline
Title
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
Description
• 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.
Time Frame
12 months
Title
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
Description
• 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.
Time Frame
6 months
Title
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
Description
• 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.
Time Frame
baseline
Title
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
Description
• 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
Time Frame
12 months
Title
Evaluate the impact of this text message-based intervention compared to usual care at 6 months using self-reported A1c
Description
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
Time Frame
6 months
Title
To compare A1c between the intervention and control groups at baseline by measuring self-reported A1c
Description
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
Time Frame
baseline
Title
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
Description
• 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.
Time Frame
12 months
Title
To compare the number of diabetes-related ED visits in the 24 months prior to enrolment in the intervention vs. control group at baseline
Description
• 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.
Time Frame
baseline
Title
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
Description
• 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.
Time Frame
12 months
Title
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
Description
• 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.
Time Frame
Baseline
Title
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
Description
• 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.
Time Frame
12 months
Title
Number of diabetes-related physician visits at baseline for both intervention and control populations 24 months prior to describe baseline characteristics
Description
• 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.
Time Frame
Baseline
Title
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
Description
• 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.
Time Frame
12 months
Title
Number of diabetes drug and devices claims 24 months prior to enrolment to describe baseline characteristics
Description
• 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.
Time Frame
Baseline
Title
Evaluate the impact of this text message-based intervention costs compared to usual care costs
Description
Costs of implementation will be collected to ascertain the cost of developing and using this intervention in a hospital setting in Ontario and Quebec; variables that will be collected for this analysis will include: salaries for staff working on the design, development and management of the intervention for the entire intervention duration; salary of research coordinators working to onboard participants to the intervention; cost of digital services and office equipment needed to develop and manage the intervention (computers, hosting service, servers); cost of REDcap servers and hospital IT support for REDCap integration with MEMOTEXT platform Aggregate and direct medical costs associated with the intervention and its implementation will be measured for the 12 months of the intervention duration using study and administrative data
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages
Description
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
Time Frame
12 months
Title
Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with
Description
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
Time Frame
12 months
Title
Evaluation of intervention fidelity
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rayzel Shulman, MD, PhD
Phone
416-813-6218
Email
rayzel.shulman@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mikayla Sonnenberg
Email
mikayla.sonnenberg@sickkids.ca
Facility Information:
Facility Name
Oak Valley Health
City
Markham
State/Province
Ontario
ZIP/Postal Code
L9P1S4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alanna Landry
Email
alandry@msh.on.ca
Facility Name
Trillium Health Partners
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B2V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Zenlea, MD
Email
ian.zenlea@thp.ca
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Goldbloom, MD
Email
egoldbloom@cheo.on.ca
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rayzel Shulman, MD/PhD
Phone
4168136218
Email
rayzel.shulman@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Geetha Sanmugalingham, MSc
Email
geetha.sanmugalingham@sickkids.ca
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meranda Nakhla, MD
Email
meranda.nakhla@mcgill.ca
Facility Name
Saint Justine Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Henderson, MD
Email
melanie.henderson.hsj@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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