Type 2 Diabetes
Conditions
Brief 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).
Detailed description
Study Overview. Two hundred participants will be randomized 1:1 to Home DM-BAT (n=100) or the control condition (n=100) to control for attention. The intervention includes 8 weekly intervention sessions and 10 monthly booster sessions. Primary analyses will be conducted at 12 months post-randomization. Description of the Home DM-BAT Intervention: A trained nurse educator will deliver the manualized Home DM-BAT intervention via telephone. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12. All intervention sessions will be delivered by telephone and will include a previously tested diabetes education/skills training intervention based on ADA guidelines, diabetes-tailored behavioral activation and will address social determinant of health issues. Control Group (GHE+ST): Patients randomized to the control group will receive in-home, telephone-delivered 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 to match the intervention group for both content and attention. The control group will not receive diabetes education, address social determinants of health, or behavioral activation.
Interventions
BEHAVIORALSupportive Therapy (Control)
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
BEHAVIORALHome 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.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=65 years of age; 2. Self-identified as Black/African American or Hispanic; 3. Clinical diagnosis of T2DM verified by an HbA1c \>=8% at the screening assessment; 4. Able to communicate in English or Spanish; and 5. 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
1. Mental confusion at screening assessment suggesting significant dementia; 2. Participation in other diabetes research; 3. Alcohol or drug abuse/dependency; 4. Active psychosis or acute mental disorder; and 5. Life expectancy \<12 months at screening assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control (HbA1c) | HbA1c at 12 months post intervention follow-up | About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeonard E Egede, MD, MS
State University of New York at Buffalo
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.7 Years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hemoglobin A1c | 9.5 mean percentage of HbA1c STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Hispanic | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 154 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 0 / 99 | 0 / 101 |
| serious Total, serious adverse events | 0 / 99 | 0 / 101 |
Outcome results
None listed