Weight Management of Dialysis Patients

Hypertension Clinical Trial

Official title:

Clinical Randomized Controlled Trial of Weight Intervention to Improve Volumetric Load in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333574
• Other study ID #: CDUTCM20240313
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Qinxiu Zhang Professor
• Phone: 18980880173
• Email: zhqinxiu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age =18;

• Dialysis age =3 months;

• Survival =12 months;

• Patients themselves or family members can use wechat;

• Informed consent

Exclusion Criteria:

• Have a cognitive or intellectual disability unable to read and understand SMS;

• Have mental illness;

• Other serious complications occurred

Related Conditions & MeSH terms

• Body Weight
• Cardiovascular Events
• Dry Weight
• Hemodialysis
• Hypertension
• Interdialytic Weight Gain
• Life Quality
• Weight Gain

Intervention

Other:
• Family weight self-measurement and remote follow-up management based on wechat.
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.
• Routine care
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
qinxiu zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event rate	incidence of cardiovascular events (or hospitalization rate due to cardiovascular events such as hypertension and heart failure)	4, 8, and 12 weeks after intervention
Primary	Rate of completion	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)	4, 8, and 12 weeks after intervention
Secondary	dialysis related symptoms	(fatigue, weakness, pruritus, dialysis patient quality of Life scale)	4, 8, and 12 weeks after treatment
Secondary	Laboratory index	hemoglobin	4, 8, and 12 weeks after treatment
Secondary	level of Ga	Laboratory index	4, 8, and 12 weeks after treatment
Secondary	level of P		4, 8, and 12 weeks after treatment
Secondary	level of PTH		4, 8, and 12 weeks after treatment
Secondary	level of K		4, 8, and 12 weeks after treatment
Secondary	level of Na		4, 8, and 12 weeks after treatment
Secondary	level of Cl		4, 8, and 12 weeks after treatment
Secondary	concentration of albumin and prealbumin		4, 8, and 12 weeks after treatment
Secondary	Laboratory index of total protein		4, 8, and 12 weeks after treatment
Secondary	Dialysis efficiency \ dialysis adequacy (KTV)	Dialysis efficiency \ dialysis adequacy (KTV)	4, 8, and 12 weeks after treatment