A study on effect of App-based monitoring of systemic hypertension and disease progression in patients with Chronic Kidney Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Decline in eGFR
研究概览
简要总结
This study is done among patients with chronic kidney disease coming to OPD of general medicine and nephrology in saveetha medical college and hospital.The patients recruited for the study are randomized into the control and intervention gropup.Patients in both groups receive standard guidline therapy.An App based monitoring system is used in addition to standard care in the intervention group This app is mainly based on periodic inputs of data from both the patient as well as the healthcare provider (treating physician or nephrologist). Separate channel for input of data through telephone interviews by the healthcare provider has been created to include illiterate and less technologically enabled patients. Health data relating to symptoms of CKD will be entered through the app on a weekly basis.Laboratory data will be entered on a monthly basis. Weekly and monthly data inputs will be relayed on standardized graphs,Voluntary surveys will be taken at beginning and end of the study period as part of “Assessment of health-related quality of life and its determinants in patients with chronic kidney disease.” Dietary advise and disease information tailored to a specific patient as deemed by the health care provider is provided in the form of text and video supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18 to 60 years 2.Patients diagnosed to Chronic Kidney disease stage 2 to stage 4 3.Patients diagnosed to have Systemic Hypertension 4.Ability to consent 5.Patients with access to a smart phone 6.Understanding of either English or tamil language.
排除标准
- •1.Age above 60 years or age less than 18 years 2.Inability to consent 3.Patients on or requiring renal replacement therapy 4.Patients with cognitive disabilities 5.Participation in another interventional study.
结局指标
主要结局
1.Decline in eGFR
时间窗: day 1 ,day 90
2.Kidney Quality of Life index
时间窗: day 1 ,day 90
次要结局
- 1.Composite of laboratory data (hemoglobin, urea, potassium, bicarbonate)(2. Mean blood pressure)
研究者
Subash Mohan T
Saveetha Medical College and Hospital