Hierarchical Management for Maintenance Hemodialysis Patients

NCT07123168 | Completed

• 1 other identifier: surmyy2023-039
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 24 Weeks

Secondary Outcomes (3)

• Change in Disease-Related Knowledge

  Baseline, 24 Weeks

• Change in Self-Management Ability

  Baseline, 24 Weeks

• Change in Treatment Adherence

  Baseline, 24 Weeks

Study Arms (2)

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.

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.

Behavioral: routine care

Interventions

Triangle Hierarchical Management 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.

Experimental: Observation Group (Triangle Hierarchical Management)

routine care 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.

Active Comparator: Control Group (Routine Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanyan Deng: lead

Study Sites (1)

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442099, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CN (1)