Hierarchical Management for Maintenance Hemodialysis Patients

NCT ID: NCT07123168

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-11-30

Brief 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. 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.

Conditions

End-stage Renal Disease (ESRD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Observation Group (Triangle Hierarchical Management)

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.

Group Type: EXPERIMENTAL

Triangle Hierarchical Management

Intervention Type: BEHAVIORAL

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.

Active Comparator: Control Group (Routine Care)

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.

Group Type: ACTIVE_COMPARATOR

routine care

Intervention Type: BEHAVIORAL

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.

Interventions

Triangle Hierarchical Management

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.

Intervention Type: BEHAVIORAL

routine care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Diagnosed with uremia and receiving maintenance hemodialysis for ≥ 6 months.
• Willing to participate and provide written informed consent.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanyan Deng

OTHER

Sponsor Role: lead

Responsible Party

Yanyan Deng

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, China

Countries

China

Other Identifiers

surmyy2023-039

Identifier Type: -

Identifier Source: org_study_id