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临床试验/NCT01552317
NCT01552317已完成不适用

OxCKD1 - a Randomised Controlled Trial of the OxSalt1 Care Bundle to Help Renal Patients Learn How to Lower the Salt Content of Their Diets.

University of Oxford2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
2
主要终点
24-hour Urinary Sodium Excretion

研究概览

简要总结

Patients with kidney disease benefit from reducing the amount of salt in the food that they eat. The benefits include lower blood pressure and better kidney function. Therefore, lowering the amount of salt that is eaten could reduce the number of people who will develop kidney failure. The effect on blood pressure could also reduce the number of strokes and heart attacks. Similar benefits are also seen for people without kidney disease.

Guidelines for patients with kidney disease recommend that they lower the amount of salt that they eat, but most patients do not manage to do this. The reasons for this are not unclear, but are likely to reflect the difficulty that patients have in reducing the amount of salt in their food and the nature of the advice that they are given.

The investigators have developed a package of interventions to help patients to make healthier choices that will lower their salt intake. The package helps patients to learn about salt in food and how to avoid it. It provide practical advice on cutting down on salt using information booklets, text messages, emails, telephone calls, and a website.

Participants will be recruited from hospital kidney clinics and general practice. The investigators will randomly allocate participants to receive either the normal care that they would get or to receive the new package of interventions to help them lower salt. The package of interventions will involve patients receiving text messages, telephone calls, emails and written information. They will complete a questionnaire and collect urine samples which will can be used to measure the amount of salt that they are eating. No more than 6 visits will be required. The study is funded by the British Renal Society which is a charity that funds research to help patients with kidney disease.

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
Single (Participant)

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

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
  • Participant has clinically acceptable laboratory data available to confirm the diagnosis.
  • Able (in the opinion of the Investigators) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

排除标准

  • Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
  • Known salt losing nephropathy

结局指标

主要结局

24-hour Urinary Sodium Excretion

时间窗: 1 month

To evaluate whether a new care bundle helps patients to reduce their salt intake.

24-hour Urinary Salt Excretion

时间窗: 1 month

次要结局

  • 24-hour Urinary Sodium Excretion(11 months)
  • 24-hour Urinary Salt Excretion(11 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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