Weight Management of Dialysis Patients

NCT06333574 | Not Yet Recruiting

• 1 other identifier: CDUTCM20240313
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemodialysis; Life Quality; Interdialytic Weight Gain; Cardiovascular Events; Hypertension; Dry Weight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• dialysis related symptoms

  4, 8, and 12 weeks after treatment

• Laboratory index

  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 PTH

  4, 8, and 12 weeks after treatment

Study Arms (2)

Control group

OTHER

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

Intervention group

OTHER

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.

Interventions

Family weight self-measurement and remote follow-up management based on wechat. OTHER

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.

Intervention group

Routine care OTHER

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18;
• Dialysis age ≥3 months;
• Survival ≥12 months;
• Patients themselves or family members can use wechat;
• Informed consent

You may not qualify if:

• Have a cognitive or intellectual disability unable to read and understand SMS;
• Have mental illness;
• Other serious complications occurred

Sponsors & Collaborators

• qinxiu zhang: lead

Related Publications (1)

• Wang X, Yan B, Zhang S, Zhou Y, Zhang Q, Li X. Management of volume load for patients undergoing hemodialysis via WeChat and home monitoring in China: a protocol for a cluster-randomized trial. BMC Nephrol. 2025 Feb 6;26(1):58. doi: 10.1186/s12882-024-03932-0.

  PMID: 39910544 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qinxiu Zhang Professor

CONTACT

18980880173; zhqinxiu@163.com

Xueying Li Dr

CONTACT

18780906804

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, World Health Organization (WHO) Collaborating Centre

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 27, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share