Trial Outcomes & Findings for Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM (NCT NCT04203147)
NCT ID: NCT04203147
Last Updated: 2026-02-24
Results Overview
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
HbA1c at 12 months post intervention follow-up
Results posted on
2026-02-24
Participant Flow
Participant milestones
| Measure |
Home DM-BAT Intervention
A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.
Home DM-BAT: Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.
|
Control Group (GHE+ST)
Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.
Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
71
|
82
|
|
Overall Study
NOT COMPLETED
|
28
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
Baseline characteristics by cohort
| Measure |
Home DM-BAT Intervention
n=99 Participants
A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.
Home DM-BAT: Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.
|
Control Group (GHE+ST)
n=101 Participants
Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.
Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 Years
STANDARD_DEVIATION 5.0 • n=58 Participants
|
70.8 Years
STANDARD_DEVIATION 6.1
|
70.7 Years
STANDARD_DEVIATION 5.6 • n=1 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=58 Participants
|
59 Participants
|
123 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=58 Participants
|
42 Participants
|
77 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=58 Participants
|
28 Participants
|
46 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=58 Participants
|
73 Participants
|
154 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
81 Participants
n=58 Participants
|
73 Participants
|
154 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 Participants
n=58 Participants
|
28 Participants
|
46 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=58 Participants
|
101 participants
|
200 participants
n=1 Participants
|
|
Hemoglobin A1c
|
9.5 mean percentage of HbA1c
STANDARD_DEVIATION 1.6 • n=58 Participants
|
9.4 mean percentage of HbA1c
STANDARD_DEVIATION 1.6
|
9.5 mean percentage of HbA1c
STANDARD_DEVIATION 1.6 • n=1 Participants
|
PRIMARY outcome
Timeframe: HbA1c at 12 months post intervention follow-upAbout 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.
Outcome measures
| Measure |
Home DM-BAT Intervention
n=71 Participants
A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.
Home DM-BAT: Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.
|
Control Group (GHE+ST)
n=82 Participants
Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.
Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
|
|---|---|---|
|
Glycemic Control (HbA1c)
|
8.8 mean percentage of HbA1c
Standard Error 0.2
|
9.0 mean percentage of HbA1c
Standard Error 0.2
|
Adverse Events
Home DM-BAT Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group (GHE+ST)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place