Clinical trial NCT06494722: Expansion of the T1DES Pilot to a Public Hospital
Official title: Evaluating the Feasibility of Type 1 Diabetes Education and Support (T1DES) Intervention to Improve Diabetes Distress Among Black Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: diabetes
type 1
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: Emory University
name: Grady Memorial Hospital
First posted: 2024-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Diabetes Distress
timeFrame: 3 months
measure: Diabetes Distress
timeFrame: 6 months
measure: Diabetes Distress
timeFrame: 3 months
measure: Diabetes Distress
timeFrame: 6 months
measure: A1C
timeFrame: 3 months
measure: A1C
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Kaiser Permanente Georgia
name: Teaniese L Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References: