Type 1 Diabetes
Conditions
Keywords
diabetes, type 1
Brief summary
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
Detailed description
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.
Interventions
BEHAVIORALDiabetes Education
Participants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months.
BEHAVIORALT1DES
Participants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months.
Sponsors
Kaiser Permanente
The Leona M. and Harry B. Helmsley Charitable Trust
Emory University
Grady Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress | 3 months | Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100. |
| A1C | 3 months | Point of Care A1C |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTeaniese L Davis, PhD
Kaiser Permanente Georgia
Outcome results
None listed