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NCT Number: NCT07123168

Hierarchical Management for Maintenance Hemodialysis Patients

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.

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Key information

Conditions

End-stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442099, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Disease-Related Knowledge

    Time frame: 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.

  2. Change in Self-Management Ability

    Time frame: 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.

  3. Change in Treatment Adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yanyan Deng

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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