N/A
Completed N=200
Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
Source: ClinicalTrials.gov NCT04203147 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Glycemic Control (HbA1c) — 8.8; 9.0 mean percentage of HbA1c
Summary
The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, telephone-delivered, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) delivered by trained diabetes nurse educators among low income, ethnic minority seniors with poorly controlled T2DM.
The aims of this randomized controlled efficacy trial are:
Aim: To test the efficacy of Home DM-BAT on glycemic control (hemoglobin A1c).
Hypothesis: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in glycemic control (hemoglobin A1c) at 12 months of follow-up compared to the control group (in-home, telephone-delivered supportive therapy - ST).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control (HbA1c) |
8.8; 9.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age >=65 years of age;
- Self-identified as Black/African American or Hispanic;
- Clinical diagnosis of T2DM verified by an HbA1c >=8% at the screening assessment;
- Able to communicate in English or Spanish; and
- Resident of independent, subsidized, assisted senior housing facility or community dwelling elderly adults in the greater Milwaukee area and surrounding counties that have high African American/Hispanic populations.
Exclusion Criteria
- Mental confusion at screening assessment suggesting significant dementia;
- Participation in other diabetes research;
- Alcohol or drug abuse/dependency;
- Active psychosis or acute mental disorder; and
- Life expectancy <12 months at screening assessment.
Data sourced from ClinicalTrials.gov (NCT04203147). 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.