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NCT04831697Completed

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

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

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
25 Mar 2021
Start date
Dec 2021
Primary completion date
Feb 2024
Lead sponsor
Medical College of Wisconsin
NCT number
NCT04831697

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From Dec 2021 to the primary completion date, Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder
  • Participation in other diabetes trials

Other

  • Life expectancy \<6 months based on screening questionnaire

Who the study is looking for

  • Age 40-64 years
  • Self-identifies as female
  • Self-identifies as African American or Non-Hispanic Black
  • Self-reports multi-caregiving responsibilities
  • Clinical diagnosis of T2DM based on HbA1c≥8% at the screening/baseline assessment
  • Able to communicate in English
  • Access to a telephone (i.e., landline, mobile device, smart device, etc.)

Age in the registry: 40 years to 64 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.