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Behavioral Intervention

Diabetes Education and Support for Type 2 Diabetes

N/A

Recruiting

Led By Aprill Z Dawson, PhD, MPH

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported diagnosis of T2DM

Age 50 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline hba1c at 6 months post intervention follow-up

Awards & highlights

Study Summary

This trial will test a nurse case-manager, telephone-delivered intervention to help African Americans aged 50+ with uncontrolled type 2 diabetes manage their diabetes and address social needs.

Who is the study for?

This trial is for African Americans aged 50 or older with poorly controlled type 2 diabetes (HbA1C levels of at least 8%). Participants must self-identify as Black and have a diagnosis of T2DM. Those with significant dementia, involvement in other diabetes trials, substance abuse issues, or a life expectancy less than six months cannot join.Check my eligibility

What is being tested?

The study compares the effectiveness of two approaches: a nurse-led intervention providing education and skills training along with addressing social needs (DM Social Needs), versus usual care. It involves randomly placing participants into one of these two groups to see which method better improves clinical and patient-reported outcomes.See study design

What are the potential side effects?

Since this trial focuses on education and skills training rather than medication, it does not list specific side effects like drug studies do. However, any potential discomfort from lifestyle changes or stress from participation will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline hba1c at 6 months post intervention follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline hba1c at 6 months post intervention follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline hba1c at 6 months post intervention follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycemic Control (Hemoglobin A1C [HbA1C])

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DM Social Needs InterventionExperimental Treatment1 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.

Group II: Usual CareActive Control1 Intervention

Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,613 Total Patients Enrolled

Aprill Z Dawson, PhD, MPHPrincipal InvestigatorMedical College of Wisconsin

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being welcomed into this trial?

"Affirmative. According to the information accessible from clinicaltrials.gov, this examination is currently recruiting test subjects. It was first posted on August 1st 2023 and has been updated as recently as October 17th 2023, with a total of 100 patients being admitted at one site."

Answered by AI

What is the scope of individuals receiving treatment in this experiment?

"Affirmative. The trial is currently recruiting participants, as evidenced by clinicaltrials.gov's records that point to its posting on August 1st 2023 and the most recent amendment made October 17th of the same year. This medical experiment requires 100 individuals from a single location to complete it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diabetes Education/Skills Training and Social Needs Resolution Intervention

Aprill Z. Dawson, PhD, MPH 2023. "Diabetes Education/Skills Training and Social Needs Resolution Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935410.