Group-based Chronic Kidney Disease Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood pressure control
研究概览
简要总结
A two-group randomized clinical trial testing whether group-based care is feasible and will help improve blood pressure control in adult and adolescent patients with chronic kidney disease and hypertension.
详细描述
This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.
There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent Age ≥12 years old
- •Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider)
- •Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95 percentile (based on sex and age) at 2 clinic visits in the past year
- •For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2)
- •For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension
- •Prescription for anti-hypertensive medication (in adults)
- •Unwillingness to accept random assignment
- •Unwillingness to provide informed consent
排除标准
- •Transplanted organ
- •Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
- •Plans to relocate out of New York City in the next 6 months
研究组 & 干预措施
Group-based Care
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
干预措施: Group-based Care (Other)
Usual Care
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
结局指标
主要结局
Blood pressure control
时间窗: 6 months
The primary outcome will be blood pressure control (mean SBP \<140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
次要结局
未报告次要终点
研究者
Michal L. Melamed
Associate Professor Of Medicine & Epidemiology & Population Health
Albert Einstein College of Medicine