Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Glycemic Control (Hemoglobin A1C [HbA1C])
研究概览
简要总结
This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.
The aims of the study are:
Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).
Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.
Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.
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
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years of age;
- •Self-identified as Black/African American;
- •Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;
- •Able to communicate in English; and
- •Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.
- •Caregiver Inclusion Criteria:
- •Willing to attend 4, one-hour sessions with the study participant;
- •Willing to support the study participant for study duration (6 months); and
- •Willing to complete brief baseline, 3- and 6-month assessments.
- •Patient/Caregiver
排除标准
- •Mental confusion at screening assessment suggesting significant dementia;
- •Alcohol or drug abuse/dependency at screening assessment;
- •Active psychosis or acute mental disorder at screening assessment; and
- •Life expectancy <6 months at screening.
结局指标
主要结局
Glycemic Control (Hemoglobin A1C [HbA1C])
时间窗: Change in baseline HbA1C at 6 months post intervention follow-up
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.
次要结局
未报告次要终点
研究者
Aprill Z. Dawson, PhD, MPH
Associate Professor
Medical College of Wisconsin