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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Quality of Life (QoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosed with uremia and receiving maintenance hemodialysis for ≥ 6 months.
- •Willing to participate and provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
Experimental: Observation Group (Triangle Hierarchical Management)
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.
干预措施: Triangle Hierarchical Management (Behavioral)
Active Comparator: Control Group (Routine Care)
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.
干预措施: routine care (Behavioral)
结局指标
主要结局
Change in Quality of Life (QoL)
时间窗: 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.
次要结局
- Change in Self-Management Ability(Baseline, 24 Weeks)
- Change in Disease-Related Knowledge(Baseline, 24 Weeks)
- Change in Treatment Adherence(Baseline, 24 Weeks)
研究者
Yanyan Deng
Principal investigator
Shiyan Xiyuan Hospital