Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494722
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
Expansion of the T1DES Pilot to a Public Hospital
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Evaluating the Feasibility of Type 1 Diabetes Education and Support T1DES Intervention to Improve Diabetes Distress Among Black Young Adults
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N40 Black young adults age 18-30 years with T1D and elevated HbA1c 75 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
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 N40 Black young adults age 18-30 years with T1D and elevated HbA1c 75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R-2310-06383 | OTHER_GRANT | None | None |