Hierarchical Management for Maintenance Hemodialysis Patients

Yanyan Deng

Status: Completed

Conditions: End-stage Renal Disease (ESRD)

Treatments: Behavioral: routine care; Behavioral: Triangle Hierarchical Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07123168

surmyy2023-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental: Observation Group (Triangle Hierarchical Management)

Experimental group

Description:

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.

Treatment:

Behavioral: Triangle Hierarchical Management

Active Comparator: Control Group (Routine Care)

Active Comparator group

Description:

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.

Treatment:

Behavioral: routine care