An interventional study of Behavioral Care Coordinated with Medical Care Intervention and Behavioral Care Not Coordinated with Medical Care Intervention in Diabetes Mellitus, Type 1, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by University of Miami · Not applicable, Interventional, and Health services research
The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will work with a study team member for four months to improve your skills to manage diabetes, to strengthen the child-caregiver relationship, and/or to address emotional challenges that your child might be experiencing.
Behavioral: Behavioral Care Coordinated with Medical Care Intervention
Participants will receive the standard of care treatment for four months plus a list of clinics that accept their insurance.
Behavioral: Behavioral Care Not Coordinated with Medical Care Intervention
Participants will be meeting with a behavioral health provider during their clinic visit. Subsequent visits can be held either via telehealth or in-person. Participants should expect weekly visits during the first two months and less frequent visits (biweekly or monthly) for the last two months. Some sessions that are provided via telehealth might be video recorded and later reviewed to ensure that the program is being delivered as intended.
Participants will meet with a study team member during their in-person visit and will receive a list of clinics that are panelled with their insurance. The participants will be responsible for calling the clinics to set up their appointments. Services might be provided in person or via telehealth based on the participant's preference and the clinics' availability.
Change in Glycemic Control
Will be measured by glycosylated hemoglobin A1c
Time frame: Baseline and 4 months
Change in Diabetes Self-Management
We will measure Type 1 Diabetes Self-management using the Diabetes Management Questionnaire (DMQ; Score Range: 0-100, higher scores indicate greater adherence to diabetes management).
Time frame: Baseline and 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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