Group Education Curriculum for Older Teens With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Intervention

• Registration Number: NCT03147274
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention	Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Change from baseline self-care adherence at 12 months	12 months	Measured by the Self-Care Inventory-Revised (SCI-R)

Secondary Outcome Measures

Name	Time	Method
Change from baseline hemoglobin A1c at 12 months	12 months	Measured by DCA Vantage
Change from baseline transition readiness at 12 months	12 months	Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States