HemodialysisNCT06333574
Weight Management of Dialysis Patients
A study testing Family weight self-measurement and remote follow-up management based on wechat. and Routine care in people with Hemodialysis and Life Quality, run by qinxiu zhang.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis, Life Quality, Interdialytic Weight Gain
- What is being tested?
- Family weight self-measurement and remote follow-up management based on wechat. and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥18;
- Dialysis age ≥3 months;
- Survival ≥12 months;
- Patients themselves or family members can use wechat;
- Informed consent
Who cannot join
- Have a cognitive or intellectual disability unable to read and understand SMS;
- Have mental illness;
- Other serious complications occurred
Trial locations and contacts
No sites are listed yet.
Xueying Li Dr contact
About this study
Official title: 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.
- Conditions
- Hemodialysis, Life Quality, Interdialytic Weight Gain, Cardiovascular Events, Hypertension, Dry Weight
- Being tested
- Family weight self-measurement and remote follow-up management based on wechat., Routine care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Family weight self-measurement and remote follow-up management based on wechat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
incidence of cardiovascular events (or hospitalization rate due to cardiovascular events such as hypertension and heart failure)
Measured: 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）
Measured: 4, 8, and 12 weeks after intervention
Secondary outcomes (11)
dialysis related symptoms
(fatigue, weakness, pruritus, dialysis patient quality of Life scale)
Measured: 4, 8, and 12 weeks after treatment
Laboratory index
hemoglobin
Measured: 4, 8, and 12 weeks after treatment
level of Ga
Laboratory index
Measured: 4, 8, and 12 weeks after treatment
level of P
Measured: 4, 8, and 12 weeks after treatment
level of PTH
Measured: 4, 8, and 12 weeks after treatment
level of K
Measured: 4, 8, and 12 weeks after treatment
level of Na
Measured: 4, 8, and 12 weeks after treatment
level of Cl
Measured: 4, 8, and 12 weeks after treatment
concentration of albumin and prealbumin
Measured: 4, 8, and 12 weeks after treatment
Laboratory index of total protein
Measured: 4, 8, and 12 weeks after treatment
Dialysis efficiency \ dialysis adequacy (KTV)
Dialysis efficiency \ dialysis adequacy (KTV)
Measured: 4, 8, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- qinxiu zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, qinxiu zhang, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333574
- Sponsor's protocol ID
- CDUTCM20240313
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39910544
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Randomized Controlled Trial of Weight Intervention to Improve Volumetric Load in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06333574
- Acronym / sponsor ID
- CDUTCM20240313
- Conditions
- Hemodialysis, Life Quality, Interdialytic Weight Gain, Cardiovascular Events, Hypertension, Dry Weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- qinxiu zhangUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Routine carereceived 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 | Other | 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18;
- Dialysis age ≥3 months;
- Survival ≥12 months;
- Patients themselves or family members can use wechat;
- Informed consent
Key exclusion criteria (3 listed)
- Have a cognitive or intellectual disability unable to read and understand SMS;
- Have mental illness;
- Other serious complications occurred
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention group |
| Routine careThe 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 | Control group |
Primary outcome
Adverse event rate
Time frame: 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
Time frame: 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）
11 secondary outcomes
dialysis related symptoms
Time frame: 4, 8, and 12 weeks after treatment
Laboratory index
Time frame: 4, 8, and 12 weeks after treatment
level of Ga
Time frame: 4, 8, and 12 weeks after treatment
level of P
Time frame: 4, 8, and 12 weeks after treatment
level of PTH
Time frame: 4, 8, and 12 weeks after treatment
level of K
Time frame: 4, 8, and 12 weeks after treatment
level of Na
Time frame: 4, 8, and 12 weeks after treatment
level of Cl
Time frame: 4, 8, and 12 weeks after treatment
concentration of albumin and prealbumin
Time frame: 4, 8, and 12 weeks after treatment
Laboratory index of total protein
Time frame: 4, 8, and 12 weeks after treatment
Dialysis efficiency \ dialysis adequacy (KTV)
Time frame: 4, 8, and 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 39910544Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueying Li Dr contact
Questions about this trial
What is this clinical trial studying?
A study testing Family weight self-measurement and remote follow-up management based on wechat. and Routine care in people with Hemodialysis and Life Quality, run by qinxiu zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinxiu Zhang Professor (18980880173, zhqinxiu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: 4, 8, and 12 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06333574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.