Back to resultsDiabetes Education/Skills Training and Social Needs Resolution Intervention
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DM Social Needs
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: Age 50 and older; self-identified as African American or Black; self-reported diagnosis of T2DM; HbA1C >=8% at the screening visit. Exclusion Criteria: self-reported participation in other diabetes clinical trials; alcohol or drug abuse or dependency as assessed by the CAGE-AID; Mental confusion at screening assessment suggesting significant dementia; life expectancy < 6 months at screening assessment.
Sites / Locations
- Aprill DawsonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DM Social Needs Intervention
Usual Care
Arm Description
A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone.
Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly
Outcomes
Primary Outcome Measures
Glycemic Control (Hemoglobin A1C [HbA1C])
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
Secondary Outcome Measures
Full Information
NCT ID
NCT05935410
First Posted
June 27, 2023
Last Updated
October 17, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05935410
Brief Title
Diabetes Education/Skills Training and Social Needs Resolution Intervention
Official Title
Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (DM Social Needs)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms.
The aims of this study are:
Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes.
Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DM Social Needs Intervention
Arm Type
Experimental
Arm Description
A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly
Intervention Type
Behavioral
Intervention Name(s)
DM Social Needs
Intervention Description
6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.
Primary Outcome Measure Information:
Title
Glycemic Control (Hemoglobin A1C [HbA1C])
Description
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
Time Frame
Change in baseline HbA1C at 6 months post intervention follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 50 and older;
self-identified as African American or Black;
self-reported diagnosis of T2DM;
HbA1C >=8% at the screening visit.
Exclusion Criteria:
self-reported participation in other diabetes clinical trials;
alcohol or drug abuse or dependency as assessed by the CAGE-AID;
Mental confusion at screening assessment suggesting significant dementia;
life expectancy < 6 months at screening assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aprill Z Dawson, PhD, MPH
Phone
414-955-8828
Email
adawson@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer A Campbell, PhD, MPH
Phone
414-955-8829
Email
jacampbell@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aprill Z Dawson, PhD, MPH
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aprill Dawson
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aprill Dawson
Phone
414-955-8828
Email
adawson@mcw.edu
12. IPD Sharing Statement
Learn more about this trial
Diabetes Education/Skills Training and Social Needs Resolution Intervention
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