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OpenTrials
Completed

NCT Number: NCT05915975

Integrated Behavioral Healthcare for Youth With Type 1 Diabetes

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes diagnosed for one year or more
  • Latino or Black ethnicity/race
  • Speak and read English or Spanish
  • Eligibility for Medicaid

Exclusion criteria

  • Significant developmental disability
  • Serious psychiatric disorder
  • Another serious chronic illness

Treatment and study plan

Behavioral Care Coordinated with Medical Care Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Glycemic Control

    Time frame: Baseline and 4 months

    Will be measured by glycosylated hemoglobin A1c

Secondary outcomes

  1. Change in Diabetes Self-Management

    Time frame: Baseline and 4 months

    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).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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