Home-Based Chronic Kidney Disease (CKD) Care in Native American's of New Mexico- A Disruptive Innovation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 2
- 主要终点
- The Patient Activation Measure (PAM)
研究概览
简要总结
People reach End Stage Renal Disease (ESRD) due to progressive chronic kidney disease (CKD). CKD is associated with increased risk for heart disease and death. The burden of chronic kidney disease is increased among minority populations compared to Caucasians. New Mexico American Indians are experiencing an epidemic of chronic kidney disease due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rates of ESRD by early interventions in CKD. Investigators propose to assess the safety and efficacy of conducting a full-scale study to determine if home based care delivered by a collaborative team composed of community health workers, the Albuquerque Area Indian Health Board and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.
详细描述
Hypothesis:
Specific Aim 1: Screen 600 participants from four different American Indian tribes in New Mexico to identify incident cases of CKD and identify participants for the proposed study of HBKC;
Specific Aim 2: Conduct a 12 month study of HBKC among 240 Native Americans randomized in a 1:1 allocation to HBKC group versus Delayed Intervention (DI) group to demonstrate improvement in Patient Activation Measures (PAM) and adherence to treatment. We will demonstrate that CKD clinical risk profiles will improve with HBKC as compared to DI at 12 months and 4 months post intervention (16 months);
Specific Aim 3: To demonstrate that HBKC will improve psychological factors that map onto important cultural variations in treatment efficacy and health outcomes. Specifically, we will show improvement in potential mediators (treatment engagement, self-efficacy, coping and increased knowledge) and moderators (stigma, and chronic stress, and depression) of health disparity and outcome.
Study Outcomes: (1) The patient activation measures and adherence; (2) Changes in clinical phenotypes including Cr, UACR, A1c, body weight, BMI, fasting glucose, blood pressure (BP), plasma lipids, and inflammatory markers; (3) Changes in the quantitative traits such as diet and scores from a battery of mental-health, self-efficacy, and quality of life instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) live in a household with 1 participant
- •(2) age 21 to 80 years
- •(3) negative pregnancy test in women of child-bearing potential
- •(4) diagnosed diabetics or HbA1c >7
- •(5) BMI >27 kg/m2 and UACR of >/= 30
排除标准
- •(1) life expectancy < 1 year
- •(2) pregnancy or absence of reliable birth control in women of child-bearing potential
- •(3) malignancy except non-melanoma skin cancer
- •(4) blind
- •(5) ESRD and on dialysis
- •(6) kidney transplant recipient
- •(7) unwilling or unable to give informed consent.
结局指标
主要结局
The Patient Activation Measure (PAM)
时间窗: Baseline, 6 and 12 months
Assesses an individual's knowledge, skill, and confidence for managing one's health and healthcare. PAM total scores have a theoretical range from 0 to 100, with higher scores representing greater patient activation.
次要结局
- HbA1c(Baseline. Change from baseline at 6 and 12 months)
- Blood Glucose Levels(Baseline. Change from baseline at 6 and 12 months)
- HDL(Baseline. Change from baseline at 6 and 12 months)
- LDL(Baseline. Change from baseline at 6 and 12 months)
- Creatinine(Baseline. Change from baseline at 6 and 12 months)
- SF12 Physical(Baseline. Change from baseline at 6 and 12 months)
- SF12 Mental(Baseline. Change from baseline at 6 and 12 months)
研究者
Vallabh O Shah
Professor
University of New Mexico