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Group Education Curriculum for Older Teens With Type 1 Diabetes (SMART T1D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03147274
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
Katharine Garvey, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention Group
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
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.

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

Primary Outcome Measures :
  1. Change from baseline self-care adherence at 12 months [ Time Frame: 12 months ]
    Measured by the Self-Care Inventory-Revised (SCI-R)

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03147274

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: Katharine Garvey, MD, MPH Boston Children’s Hospital

Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. Erratum in: Diabetes Care. 2012 Jan;35(1):191.
Logan J, Peralta E, Brown K, Moffett M, Advani A, Leech N. Smoothing the transition from paediatric to adult services in type 1 diabetes. J Diabetes Nurs. 2008;12:328-38.

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Responsible Party: Katharine Garvey, Pediatric Endocrinologist, Boston Children’s Hospital Identifier: NCT03147274     History of Changes
Other Study ID Numbers: IRB-P00023671
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katharine Garvey, Boston Children’s Hospital:
Diabetes Mellitus, Type 1
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases