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

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ClinicalTrials.gov Identifier: NCT03147274
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Katharine Garvey, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE May 5, 2017
First Posted Date  ICMJE May 10, 2017
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE May 3, 2017
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Change from baseline self-care adherence at 12 months [ Time Frame: 12 months ]
Measured by the Self-Care Inventory-Revised (SCI-R)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03147274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • Change from baseline transition readiness at 12 months [ Time Frame: 12 months ]
    Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)
  • Change from baseline hemoglobin A1c at 12 months [ Time Frame: 12 months ]
    Measured by DCA Vantage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Group Education Curriculum for Older Teens With Type 1 Diabetes
Official Title  ICMJE Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
    Intervention: Behavioral: Intervention
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2017)
70
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03147274
Other Study ID Numbers  ICMJE IRB-P00023671
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers
Responsible Party Katharine Garvey, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katharine Garvey, MD, MPH Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP