HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Glycemic Control (HbA1c)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Home DM-BAT (Behavioral)
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.
干预措施: Supportive Therapy (Control) (Behavioral)
结局指标
主要结局
Glycemic Control (HbA1c)
时间窗: 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.
次要结局
未报告次要终点
研究者
Leonard Ehianu Egede
Professor & Chair, Department of Medicine
State University of New York at Buffalo