Weight Management of Dialysis Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Hemodialysis; Cardiovascular Events; Interdialytic Weight Gain; Life Quality; Dry Weight
• Intervention / Treatment: Other: Routine care; Other: Family weight self-measurement and remote follow-up management based on wechat.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinxiu Zhang Professor; Phone Number: 18980880173; Email: zhqinxiu@163.com
• Study Contact Backup: Name: Xueying Li Dr; Phone Number: 18780906804

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
dialysis related symptoms	(fatigue, weakness, pruritus, dialysis patient quality of Life scale)	4, 8, and 12 weeks after treatment
Laboratory index	hemoglobin	4, 8, and 12 weeks after treatment
level of Ga	Laboratory index	4, 8, and 12 weeks after treatment
level of P		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
level of Cl		4, 8, and 12 weeks after treatment
concentration of albumin and prealbumin		4, 8, and 12 weeks after treatment
Laboratory index of total protein		4, 8, and 12 weeks after treatment
Dialysis efficiency \ dialysis adequacy (KTV)	Dialysis efficiency \ dialysis adequacy (KTV)	4, 8, and 12 weeks after treatment

Collaborators and Investigators

• Sponsor: qinxiu zhang

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain
• Other Study ID Numbers: CDUTCM20240313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No