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Social Support & Diabetes Education for Type 2 Diabetes (MCGR21 Trial)

N/A

Recruiting

Led By Joni Williams, MD, 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

Age 40-64 years

Clinical diagnosis of T2DM based on HbA1c≥8% at the screening/baseline assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening/baseline, 3-months, 6-months

Awards & highlights

MCGR21 Trial Summary

This trial will compare the effects of two different interventions on African American women with diabetes who also have multi-caregiving responsibilities. One intervention will focus on social support and the other will focus on diabetes education and skills training.

Who is the study for?

This trial is for African American women aged 40-64 in Milwaukee with Type 2 Diabetes (HbA1c ≥8%) and multiple caregiving responsibilities. They must speak English, have access to a phone, and not be involved in other diabetes trials or have conditions like significant dementia or life expectancy less than 6 months.Check my eligibility

What is being tested?

The study compares two approaches: one group receives support specifically tailored to their multi-caregiving roles, while the other gets general diabetes education. Both groups will have sessions over the phone with health educators for up to an hour each week.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, traditional side effects are not expected. However, participants may experience stress or emotional discomfort when discussing personal topics.

MCGR21 Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 64 years old.

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My diabetes diagnosis was confirmed with an HbA1c level of 8% or higher.

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I identify as female.

MCGR21 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening/baseline, 3-months, 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening/baseline, 3-months, 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening/baseline, 3-months, 6-months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Glycemic Control from Baseline to 6 months

Secondary outcome measures

Change in Blood Glucose Monitoring from Baseline to 6 months

Change in Blood Pressure Control from Baseline to 6 months

Change in Diet from Baseline to 6 months

+3 more

MCGR21 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multi-Caregiving InterventionExperimental Treatment1 Intervention

The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals.

Group II: Diabetes Enhanced Usual Care InterventionActive Control1 Intervention

This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,523 Total Patients Enrolled

Joni Williams, MD, MPHPrincipal InvestigatorMedical College of Wisconsin

Media Library

Diabetes Enhanced Usual Care Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04831697 — N/A

Type 2 Diabetes Research Study Groups: Multi-Caregiving Intervention, Diabetes Enhanced Usual Care Intervention

Type 2 Diabetes Clinical Trial 2023: Diabetes Enhanced Usual Care Intervention Highlights & Side Effects. Trial Name: NCT04831697 — N/A

Diabetes Enhanced Usual Care Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04831697 — N/A

Frequently Asked Questions

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

Could I potentially qualify for participation in this medical research?

"This clinical trial seeks 60 individuals between 40 and 64 years of age, who have been clinically diagnosed with type 2 diabetes mellitus as evidenced by an HbA1c≥8% at the screening/baseline assessment. Furthermore, applicants must identify as African American or Non-Hispanic Black, possess multi-caregiving responsibilities, be female in gender identity, communicate fluently in English and have access to a telephone device (e.g., landline)."

Answered by AI

Are there any vacancies remaining in this clinical research endeavor?

"According to information posted on clinicaltrials.gov, this investigation is actively looking for participants with the trial having been initially advertised December 14th 2021 and last revised April 6th 2022."

Answered by AI

Does the criteria for participants in this experiment include those over fifty years of age?

"This particular medical experiment is only open to those aged 40-64. Conversely, there are 192 clinical trials for minors and 1027 studies available for individuals over the age of 65."

Answered by AI

What is the size of the cohort participating in this experiment?

"Affirmative. According to information posted on clinicaltrials.gov, the trial which began recruitment on December 14th 2021 is open for enrollment with 60 participants being accepted at one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden

Joni Williams 2021. "Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04831697.