Group Education Curriculum for Older Teens With Type 1 Diabetes

NCT03147274 | Completed DMC

• 1 other identifier: IRB-P00023671
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1; Adolescence

Outcome Measures

Primary Outcomes (1)

• Change from baseline self-care adherence at 12 months

  Measured by the Self-Care Inventory-Revised (SCI-R)

  12 months

Secondary Outcomes (2)

• Change from baseline transition readiness at 12 months

  12 months

• Change from baseline hemoglobin A1c at 12 months

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Intervention

Control Group

NO INTERVENTION

These participants will receive no intervention. They will have clinic care as usual and will receive three diabetes newsletters to match for attention.

Interventions

Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• Major medical or psychiatric comorbidities
• Established patients of one of the diabetes nurse educators delivering the intervention

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (29)

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  BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Katharine Garvey, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 10, 2017
• Study Start: May 3, 2017
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)