Group Education Curriculum for Older Teens With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— SMART T1D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147274
• Other study ID #: IRB-P00023671
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: February 21, 2019

Study information

• Verified date: April 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Intervention
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29. — View Citation

Schwartz LA, Brumley LD, Tuchman LK, Barakat LP, Hobbie WL, Ginsberg JP, Daniel LC, Kazak AE, Bevans K, Deatrick JA. Stakeholder validation of a model of readiness for transition to adult care. JAMA Pediatr. 2013 Oct;167(10):939-46. doi: 10.1001/jamapediatrics.2013.2223. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline self-care adherence at 12 months	Measured by the Self-Care Inventory-Revised (SCI-R)	12 months
Secondary	Change from baseline transition readiness at 12 months	Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)	12 months
Secondary	Change from baseline hemoglobin A1c at 12 months	Measured by DCA Vantage	12 months