Diabetes Education/Skills Training and Social Needs Resolution Intervention
NCT ID: NCT05935410
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-08-01
2025-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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DM Social Needs Intervention
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.
DM Social Needs
6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.
Usual Care
Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly
Usual Care
Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.
Interventions
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DM Social Needs
6-monthly sessions of telephone delivered, manualized education and skills training on diabetes management, and problem solving and resolution of social needs.
Usual Care
Diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) will be mailed monthly.
Eligibility Criteria
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Inclusion Criteria
2. self-identified as African American or Black;
3. self-reported diagnosis of T2DM;
4. HbA1C \>=8% at the screening visit.
Exclusion Criteria
2. alcohol or drug abuse or dependency as assessed by the CAGE-AID;
3. Mental confusion at screening assessment suggesting significant dementia;
4. life expectancy \< 6 months at screening assessment.
50 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Aprill Z. Dawson, PhD, MPH
Assistant Professor
Principal Investigators
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Aprill Z Dawson, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Aprill Dawson
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO00046456
Identifier Type: -
Identifier Source: org_study_id
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