Hierarchical Management for Maintenance Hemodialysis Patients

Not Applicable

Completed

• Conditions: End-stage Renal Disease (ESRD)

• Registration Number: NCT07123168
• Lead Sponsor: Yanyan Deng

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.

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (QoL)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Self-Management Ability	Baseline, 24 Weeks	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.
Change in Disease-Related Knowledge	Baseline, 24 Weeks	Measured using the 24-item Hemodialysis Knowledge Questionnaire. The total score ranges from 0 to 24, with higher scores indicating greater knowledge.
Change in Treatment Adherence	Baseline, 24 Weeks	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.

Trial Locations

Locations (1)

Renmin Hospital, Hubei University of Medicine; 🇨🇳 Shiyan, Hubei, China