Group Education Curriculum for Older Teens With Type 1 Diabetes

Study Overview
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Brief Summary
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SMART T1D is a research study that offers interactive diabetes education for teens with type 1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be randomly assigned to either receive three of the group sessions in addition to their routine clinic care or to receive their usual diabetes clinic care.

Detailed Description
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The objective of this 12-month pilot randomized controlled trial is to evaluate the impact of a 3-session group educational curriculum, compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes in the Boston Children's Hospital (BCH) Diabetes Program. Adolescents (15-18 years) with T1D will be randomized to receive a 3-session group curriculum (SMART T1D - Self-Management, Adherence and Readiness for Transition in T1D) in addition to usual care (intervention group) or to receive usual care with individual diabetes visits (control group) and electronic newsletters to match for attention.

Official Title
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Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the pediatric diabetes clinic at Boston Children's Hospital Age 15-18 years at enrollment Diabetes duration >1 year Ability to speak/read English Visits to any BCH Diabetes Program site ≥1 times over the past 6 months Hemoglobin A1c at clinic visit prior to enrollment 7.5%-11% Exclusion Criteria: Major medical or psychiatric comorbidities Established patients of one of the diabetes nurse educators delivering the intervention

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 12-month randomized controlled trial evaluating the impact of a health care delivery intervention (SMART T1D - a 3-session group educational curriculum), compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes. Intervention (group sessions) and control (standard care) subjects will complete the study on a parallel timeline.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care. | Behavioral: Intervention<br>* Patients randomized to the intervention group will attend 3 SMART T1D group curriculum sessions over the study period, in addition to usual diabetes clinic care. Each interactive group session will last 2 hours and will be facilitated by a diabetes nurse educator.<br>|
| No Intervention: Control Group<br>These participants will receive no intervention. They will have clinic care as usual and will receive three diabetes newsletters to match for attention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self-care adherence at 12 months | Measured by the Self-Care Inventory-Revised (SCI-R) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline transition readiness at 12 months | Measured by the Readiness for Independent Self-Care Questionnaire (RISQ) | 12 months | 
| Change from baseline hemoglobin A1c at 12 months | Measured by DCA Vantage | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Adolescence