End-stage Renal Disease (ESRD)NCT07123168
Hierarchical Management for Maintenance Hemodialysis Patients
A study testing Triangle Hierarchical Management and routine care in people with End-stage Renal Disease (ESRD), run by Yanyan Deng at 1 site in China.
Trial summary
This prospective, randomized controlled trial investigates the effectiveness of a nurse-led, Triangle Hierarchical Management model compared to routine care for patients on maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD)
- What is being tested?
- Triangle Hierarchical Management and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosed with uremia and receiving maintenance hemodialysis for ≥ 6 months.
- Willing to participate and provide written informed consent.
Who cannot join
- Presence of severe psychiatric, intellectual, or cognitive impairments.
- Diagnosis of severe cardiac, pulmonary, hepatic, or hematologic diseases or malignant tumors.
- Presence of a severe active infection.
- Concurrent participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Nurse-Led, Triangle-Based Hierarchical Management Model on Quality of Life, Disease-Related Knowledge, Self-Management, and Treatment Adherence in Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Trial
This prospective, randomized controlled trial investigates the effectiveness of a nurse-led, Triangle Hierarchical Management model compared to routine care for patients on maintenance hemodialysis. The study aims to determine if this risk-stratified management approach improves patients' quality of life, disease-related knowledge, self-management capabilities, and treatment adherence over a 24-week period.
Read the detailed description
Patients undergoing maintenance hemodialysis (MHD) face significant disease burdens, leading to poor quality of life and suboptimal self-management. Conventional nursing care often lacks individualized strategies. The "Triangle" model of chronic care management, which stratifies patients into high-, medium-, and low-risk tiers, allows for targeted allocation of healthcare resources and education. This study adapted this model for an MHD population through a Delphi consultation with experts. Eighty patients were randomized to either receive the Triangle Hierarchical Management intervention or routine care for 24 weeks. The intervention group received tailored nursing support based on their risk level, which was re-assessed weekly. The study's objective is to provide evidence on whether this structured, risk-based nursing model is superior to standard care in improving key patient-reported outcomes for the MHD population in China.
- Conditions
- End-stage Renal Disease (ESRD)
- Being tested
- Triangle Hierarchical Management, routine care
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triangle Hierarchical ManagementBehavioural
A nurse-led, risk-stratified management model where patients are categorized into high-, medium-, or low-risk tiers. High-risk patients receive intensive professional care (90%) and minimal self-management education (10%); medium-risk patients receive a balanced approach (50% each); and low-risk patients focus on self-management education (90%) with minimal professional care (10%). The intervention is delivered by trained nurses over 24 weeks.
routine careBehavioural
Standard nursing management for hemodialysis patients, including monthly monitoring, routine assessments, and general health education sessions. This care does not involve risk stratification or tailored interventions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Observation Group (Triangle Hierarchical Management) | Experimental | Participants received care based on a nurse-led, Triangle Hierarchical Management model for 24 weeks. Upon enrollment, patients were stratified into high-, medium-, or low-risk tiers based on clinical, functional, and psychological criteria. Management strategies, including nurse-to-patient ratios, health education intensity, and psychological support, were tailored to the risk tier. Patients were re-evaluated weekly, and their risk classification and management plan were adjusted accordingly. Receives: Behavioral: Triangle Hierarchical Management |
| Active Comparator: Control Group (Routine Care) | Active comparator | Participants received routine nursing care for 24 weeks. This included standard monitoring of laboratory parameters and vital signs, vascular access assessment, and one general health education session per month for patients and/or their families. Receives: Behavioral: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QoL)
Measured using the Mandarin Chinese version of the Kidney Disease Quality of Life-Short Form (KDQOL-SF™ 1.3). The instrument assesses both kidney disease-targeted areas (KDTA) and generic health (SF-36). Scores for each domain are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: Baseline, 24 Weeks
Secondary outcomes (3)
Change in Disease-Related Knowledge
Measured using the 24-item Hemodialysis Knowledge Questionnaire. The total score ranges from 0 to 24, with higher scores indicating greater knowledge.
Measured: Baseline, 24 Weeks
Change in Self-Management Ability
Measured using the 20-item Hemodialysis Self-Management Instrument (HD-SMI). The total score ranges from 20 to 80, with higher scores reflecting better self-management ability.
Measured: Baseline, 24 Weeks
Change in Treatment Adherence
Measured using the 23-item Treatment Adherence Scale for Hemodialysis Patients. The total score ranges from 23 to 115, with higher scores indicating better adherence.
Measured: Baseline, 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal Disease (ESRD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanyan Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanyan Deng, Shiyan Xiyuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123168
- Sponsor's protocol ID
- surmyy2023-039
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led, Triangle-Based Hierarchical Management Model on Quality of Life, Disease-Related Knowledge, Self-Management, and Treatment Adherence in Patients Undergoing Maintenance Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07123168
- Acronym / sponsor ID
- surmyy2023-039
- Conditions
- End-stage Renal Disease (ESRD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yanyan DengUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Aug 2025 (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.
This prospective, randomized controlled trial investigates the effectiveness of a nurse-led, Triangle Hierarchical Management model compared to routine care for patients on maintenance hemodialysis. The study aims to determine if this risk-stratified management approach improves patients' quality of life, disease-related knowledge, self-management capabilities, and treatment adherence over a 24-week period.
Detailed description
Patients undergoing maintenance hemodialysis (MHD) face significant disease burdens, leading to poor quality of life and suboptimal self-management. Conventional nursing care often lacks individualized strategies. The "Triangle" model of chronic care management, which stratifies patients into high-, medium-, and low-risk tiers, allows for targeted allocation of healthcare resources and education. This study adapted this model for an MHD population through a Delphi consultation with experts. Eighty patients were randomized to either receive the Triangle Hierarchical Management intervention or routine care for 24 weeks. The intervention group received tailored nursing support based on their risk level, which was re-assessed weekly. The study's objective is to provide evidence on whether this structured, risk-based nursing model is superior to standard care in improving key patient-reported outcomes for the MHD population in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Observation Group (Triangle Hierarchical Management) | Experimental | Behavioral: Triangle Hierarchical ManagementParticipants received care based on a nurse-led, Triangle Hierarchical Management model for 24 weeks. Upon enrollment, patients were stratified into high-, medium-, or low-risk tiers based on clinical, functional, and psychological criteria. Management strategies, including nurse-to-patient ratios, health education intensity, and psychological support, were tailored to the risk tier. Patients were re-evaluated weekly, and their risk classification and management plan were adjusted accordingly. |
| Active Comparator: Control Group (Routine Care) | Active comparator | Behavioral: routine careParticipants received routine nursing care for 24 weeks. This included standard monitoring of laboratory parameters and vital signs, vascular access assessment, and one general health education session per month for patients and/or their families. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Diagnosed with uremia and receiving maintenance hemodialysis for ≥ 6 months.
- Willing to participate and provide written informed consent.
Key exclusion criteria (4 listed)
- Presence of severe psychiatric, intellectual, or cognitive impairments.
- Diagnosis of severe cardiac, pulmonary, hepatic, or hematologic diseases or malignant tumors.
- Presence of a severe active infection.
- Concurrent participation in another clinical trial.
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 |
|---|---|---|
| Triangle Hierarchical ManagementA nurse-led, risk-stratified management model where patients are categorized into high-, medium-, or low-risk tiers. High-risk patients receive intensive professional care (90%) and minimal self-management education (10%); medium-risk patients receive a balanced approach (50% each); and low-risk patients focus on self-management education (90%) with minimal professional care (10%). The intervention is delivered by trained nurses over 24 weeks. | Behavioural | Experimental: Observation Group (Triangle Hierarchical Management) |
| routine careStandard nursing management for hemodialysis patients, including monthly monitoring, routine assessments, and general health education sessions. This care does not involve risk stratification or tailored interventions. | Behavioural | Active Comparator: Control Group (Routine Care) |
Primary outcome
Change in Quality of Life (QoL)
Time frame: Baseline, 24 Weeks
Measured using the Mandarin Chinese version of the Kidney Disease Quality of Life-Short Form (KDQOL-SF™ 1.3). The instrument assesses both kidney disease-targeted areas (KDTA) and generic health (SF-36). Scores for each domain are transformed to a 0-100 scale, with higher scores indicating better quality of life.
3 secondary outcomes
Change in Disease-Related Knowledge
Time frame: Baseline, 24 Weeks
Change in Self-Management Ability
Time frame: Baseline, 24 Weeks
Change in Treatment Adherence
Time frame: Baseline, 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triangle Hierarchical Management and routine care in people with End-stage Renal Disease (ESRD), run by Yanyan Deng at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QoL) (time frame: Baseline, 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.