NCT07123168

Hierarchical Management for Maintenance Hemodialysis Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Yanyan Deng · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China