N/A
Completed N=60
Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Type 2 Diabetes
Source: ClinicalTrials.gov NCT04831697 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Mean Change in HbA1c% From Baseline to 6 Months — 0.57; 0.53 Mean Change in HbA1c%
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HbA1c% From Baseline to 6 Months |
0.57; 0.53 | — |
| SECONDARY Change in Physical Activity From Baseline to 6 Months |
— | — |
| SECONDARY Change in Blood Pressure Control From Baseline to 6 Months |
— | — |
| SECONDARY Change in Blood Glucose Monitoring From Baseline to 6 Months |
— | — |
| SECONDARY Change in Medication Adherence From Baseline to 6 Months |
— | — |
| SECONDARY Change in Health Related Quality of Life From Baseline to 6 Months |
— | — |
Eligibility Criteria
Inclusion criteria
- 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.)
Exclusion criteria
- Mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder
- Participation in other diabetes trials
- Life expectancy <6 months based on screening questionnaire
Data sourced from ClinicalTrials.gov (NCT04831697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.