Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Type 1, Adolescence
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline self-care adherence at 12 months | 12 months | Measured by the Self-Care Inventory-Revised (SCI-R) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline transition readiness at 12 months | 12 months | Measured by the Readiness for Independent Self-Care Questionnaire (RISQ) |
| Change from baseline hemoglobin A1c at 12 months | 12 months | Measured by DCA Vantage |
Countries
United States
Outcome results
None listed