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Completed

NCT Number: NCT03147274

Group Education Curriculum for Older Teens With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline self-care adherence at 12 months

    Time frame: 12 months

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

Secondary outcomes

  1. Change from baseline transition readiness at 12 months

    Time frame: 12 months

    Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)

  2. Change from baseline hemoglobin A1c at 12 months

    Time frame: 12 months

    Measured by DCA Vantage

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Acronym: SMART T1D

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 10, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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