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
- Diseases
- Type 2 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.