Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- The difference of rate of estimated glomerular filtration(eGFR) decline
研究概览
简要总结
Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have demonstrated that integrated pre-dialysis care may slow the decline in renal function (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early intervention especially in high risk groups like Diabetic may also improve outcome of these patients in primary health care setting resulting in delay of CKD progression.
详细描述
We conducted a 12-month longitudinal study at district A (control) and B (intervention) at Kamphaeng Phet Province, Thailand. Diabetic patients with eGFR ≥ 60 ml/min/1.73m2 were recruited from both districts. Patients in district A (control group) received standard CKD care according to NKF-K/DOQI guidelines1 whereas those in district B (intervention) received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers. During each hospital visit of both groups clinical data were assessed. All laboratory parameters were collected every 3 months, and LDL and HbA1C every 6 months. The primary end point was rate of eGFR decline. Secondary outcomes were random urine albumin to creatinine ratio (ACR), blood pressure, waist circumference, HbA1C and LDL .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice at 3 months.
排除标准
- •Active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells >3 cells/high power field or urine white blood cells >10 cells/high power field).
研究组 & 干预措施
Conventional CKD care
standard CKD care
community-based Integrated CKD care
Standard CKD care + multidisciplinary team and home visit by community care team
干预措施: Community-based Integrated CKD Care (Behavioral)
结局指标
主要结局
The difference of rate of estimated glomerular filtration(eGFR) decline
时间窗: 12 months
We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.
次要结局
- Change from baseline in low density lipoproteins(LDL)(12 months)
- Change from baseline in Random Urine Albumin to Creatinine Ratio(12 months)
- Change from baseline in waist circumference(12 months)
- Change from baseline in Hemoglobin A1C(12 months)
- Change from baseline in systolic blood pressure(12 months)