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.|
|ClinicalTrials.gov Identifier: NCT03147274|
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
Experimental: Intervention Group
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
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.
- Change from baseline self-care adherence at 12 months [ Time Frame: 12 months ]Measured by the Self-Care Inventory-Revised (SCI-R)
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03147274
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Katharine Garvey, MD, MPH||Boston Children’s Hospital|