home-based diabetes-modified behavioral activation treatment for low income seniors with t2dm

Conditions: Type 2 Diabetes

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 1: to test the efficacy of home dm-bat on clinical outcomes (hemoglobin a1c, blood pressure, and ldl-cholesterol). hypothesis 1: low income, minority seniors with poorly controlled t2dm randomized to home dm-bat will have significantly greater improvements in clinical outcomes (hemoglobin a1c, blood pressure, and ldl-cholesterol) at 12 months of follow-up compared to the control group (in-home, telephone-delivered supportive therapy - st). aim 2: to test the efficacy of home dm-bat on behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life. hypothesis 2: low income, minority seniors with poorly controlled t2dm randomized to home dm-bat will have significantly greater improvements in behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life (physical and mental health components of sf-12) at 12 months of follow-up compared to the control group. aim 3: to determine the cost-effectiveness of home dm-bat intervention for diabetes. hypothesis 3: home dm-bat will be more cost-effective in improving hemoglobin a1c levels at 12 months of follow-up, compared to the control group, as measured by differences in program costs, resource utilization, and hemoglobin a1c levels.

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. study assessments will be performed by blinded research assistants at baseline, 3-, 6-, 9-, and 12-months of follow-up. 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.

Eligibility criteria:
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.