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临床试验/NCT03009084
NCT03009084已完成不适用

Nephrocare: Multidisciplinary Care for Patients With Chronic Kidney Disease: an Increase of Patient Empowerment and Self-management by Using Interactive and Communication Tools and Nursing Interventions.

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
lipid control

研究概览

简要总结

The purpose of this study is to investigate the communication and data sharing between the primary care physician and the nephrologist about patients with chronic kidney disease. Also therapeutic interventions that change behavior and telemonitoring of the blood pressure will be explored and compared to the usual care. The most important aim of this study is to improve the quality of care for the patient with chronic kidney disease in cooperation with the primary care physician and the nephrologist.

详细描述

Through questionnaires with primary care physicians, nephrologists from the University Hospitals of Leuven and patients with chronic kidney disease, the problems will be known.

After the exploration there will be an intervention with patients who meet the in- and exclusion criteria. Around 150-200 patients will be included with a 1:2 randomisation in the control and intervention group. The relevant clinical data and the factors of lifestyle will be questioned at the baseline.

The intervention group will receive individualized therapy by a nurse, for example to quit smoking, to eat healthier and to do more physical activities. This therapy is based on the most important risk factors and will be determined before the start of the therapy. Further on, these patients will also be motivated to take their blood pressure more frequently by using a telemonitoring system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Predialysis, hemodialysis, peritoneal dialysis, transplantation
  • Included in the care program of chronic kidney diseases
  • Dutch-speaking
  • Signed and approved informed consent

排除标准

  • No Dutch-speaking
  • Impaired cognitive condition or medically unstable

研究组 & 干预措施

Intervention group

Experimental

Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.

干预措施: Lifestyle counseling (Behavioral)

Control group

No Intervention

Usual care.

结局指标

主要结局

lipid control

时间窗: one year

LDL in mmol/l

smoking cessation

时间窗: one year

percentage of smoking cessation.

blood pressure under control

时间窗: one year

percentage of patients with blood pressure within target limits

BMI change

时间窗: one year

BMI change in kg/m²

change in Estimated Glomerular Filtration Rate (eGFR)

时间窗: one year

Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²

次要结局

  • Relevant clinical data: systolic and diastolic blood pressure(one year)
  • Communication between primary care physicians and the nephrologists.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Claes

Prof. Dr.

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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