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Expansion of the T1DES Pilot to a Public Hospital

NCT06494722 · Kaiser Permanente
In plain English

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Official title
Evaluating the Feasibility of Type 1 Diabetes Education and Support (T1DES) Intervention to Improve Diabetes Distress Among Black Young Adults
About this study
This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population. The specific aims for this study are to: Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team. Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (\>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months postbaseline among participants randomized to T1DES compared to the diabetes education-only control condition. The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.
Eligibility criteria
Inclusion Criteria: * Grady Health System Patient * Aged 18 - 30 years * Confirmed diagnosis of Type 1 diabetes * Hemoglobin A1c \> 7.5 at time of enrollment * a cell phone able to send/receive text messages * Self-reported race of Black or African American * Ability to read in English and provide informed consent Exclusion Criteria: * Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent * Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions * Diabetes complications that would preclude participation in the study
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2024-03-25
Estimated completion: 2025-11-30
Last updated: 2025-03-11
Interventions
Behavioral: Diabetes EducationBehavioral: T1DES
Primary outcomes
  • Diabetes Distress (3 months)
  • Diabetes Distress (6 months)
  • Diabetes Distress (3 months)
Sponsor
Kaiser Permanente · other
With: The Leona M. and Harry B. Helmsley Charitable Trust, Emory University, Grady Memorial Hospital
Contacts & investigators
ContactTeaniese L Davis, PhD · contact · teaniese.l.davis@kp.org · 404-337-3646
InvestigatorTeaniese L Davis, PhD · principal_investigator, Kaiser Permanente Georgia
All locations (1)
Grady Health SystemRecruiting
Atlanta, Georgia, United States