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Type 1 Diabetes Education and Support Study (T1DES)

Primary Purpose

Type1diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Education
T1DES
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type1diabetes focused on measuring diabetes, type 1

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Kaiser Permanente Georgia Member at time of enrollment 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

Sites / Locations

  • Kaiser Permanente GeorgiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diabetes Education

T1DES

Arm Description

Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.

Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.

Outcomes

Primary Outcome Measures

Diabetes Distress
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Diabetes Distress
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Diabetes Distress
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Diabetes Distress
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
A1C
Point of Care A1C
A1C
Point of Care A1C

Secondary Outcome Measures

Full Information

First Posted
January 30, 2023
Last Updated
May 31, 2023
Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05735340
Brief Title
Type 1 Diabetes Education and Support Study
Acronym
T1DES
Official Title
Evaluating the Feasibility of Type 1 Diabetes Education and Support Intervention to Improve Diabetes Distress Among Black Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 the 3-year 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 post-baseline 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
diabetes, type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Education
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.
Arm Title
T1DES
Arm Type
Experimental
Arm Description
Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
T1DES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes Distress
Description
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Time Frame
3 months
Title
Diabetes Distress
Description
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Time Frame
6 months
Title
Diabetes Distress
Description
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Time Frame
3 months
Title
Diabetes Distress
Description
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Time Frame
6 months
Title
A1C
Description
Point of Care A1C
Time Frame
3 months
Title
A1C
Description
Point of Care A1C
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Kaiser Permanente Georgia Member at time of enrollment 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teaniese L Davis, PhD
Phone
404-337-3646
Email
teaniese.l.davis@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teaniese L Davis, PhD, MPH
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teaniese L Davis
Phone
404-337-3646
Email
teaniese.l.davis@kp.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Type 1 Diabetes Education and Support Study

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