Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915975
• Other study ID #: 20230308
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Luiza V Mali, Ph.D.
• Phone: (305)243-6882
• Email: lvm852[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Type 1 Diabetes diagnosed for one year or more

2. Latino or Black ethnicity/race

3. Speak and read English or Spanish

4. Eligibility for Medicaid

Exclusion Criteria:

1. Significant developmental disability

2. Serious psychiatric disorder

3. Another serious chronic illness

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Behavioral Care 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.
• Behavioral Care Not Coordinated with Medical Care Intervention
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.

Locations

Country	Name	City	State
United States	Univeristy of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycemic Control	Will be measured by glycosylated hemoglobin A1c	Baseline and 4 months
Secondary	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).	Baseline and 4 months