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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
200
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
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.
State University of New York at Buffalo
Buffalo, New York, United States
Glycemic control (HbA1c)
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.
Time frame: Change in baseline HbA1c at 12 months post intervention follow-up
Systolic and Diastolic Blood Pressure
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.
Time frame: Change in baseline blood pressure at 12 months post intervention follow-up
LDL-Cholesterol
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.
Time frame: Change in baseline cholesterol at 12 months post intervention follow-up
Quality of Life as measured by SF-12
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Time frame: Change in baseline quality of life measure at 12 months post intervention follow-up
Self-Care Behaviors
Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care. Medication Adherence will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) (Brooks 1994). Each of 6 items measures a specific medication-taking behavior.
Time frame: Change in baseline self-care behaviors at 12 months post intervention follow-up
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