Clinical Randomized Controlled Trial of Weight Intervention to Improve Volumetric Load in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Adverse event rate
研究概览
简要总结
The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:
- [Improve the self-compliance of dialysis patients with weight management]
- [alleviate the volume load of dialysis patients and reduce cardiovascular complications] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient's weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.
Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients' family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis age ≥3 months;
- •Survival ≥12 months;
- •Patients themselves or family members can use wechat;
- •Informed consent
排除标准
- •Have a cognitive or intellectual disability unable to read and understand SMS;
- •Have mental illness;
- •Other serious complications occurred
结局指标
主要结局
Adverse event rate
时间窗: 4, 8, and 12 weeks after intervention
incidence of cardiovascular events (or hospitalization rate due to cardiovascular events such as hypertension and heart failure)
Rate of completion
时间窗: 4, 8, and 12 weeks after intervention
Completion rate of home self-measured weight combined with wechat intervention(including completion rate of home self-measured weight, completion rate of wechat intervention, and combination completion rate）
次要结局
- Laboratory index(4, 8, and 12 weeks after treatment)
- level of PTH(4, 8, and 12 weeks after treatment)
- level of K(4, 8, and 12 weeks after treatment)
- level of Na(4, 8, and 12 weeks after treatment)
- concentration of albumin and prealbumin(4, 8, and 12 weeks after treatment)
- dialysis related symptoms(4, 8, and 12 weeks after treatment)
- level of Ga(4, 8, and 12 weeks after treatment)
- level of P(4, 8, and 12 weeks after treatment)
- level of Cl(4, 8, and 12 weeks after treatment)
- Laboratory index of total protein(4, 8, and 12 weeks after treatment)
- Dialysis efficiency \ dialysis adequacy (KTV)(4, 8, and 12 weeks after treatment)
研究者
qinxiu zhang
Director, World Health Organization (WHO) Collaborating Centre
Chengdu University of Traditional Chinese Medicine