Effects of a Nurse-Led Comprehensive Intervention on Frailty and Self-Management Behaviors in Patients Undergoing Peritoneal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Fried Frailty Phenotype Scale
研究概览
简要总结
This study aims to evaluate the effects of a comprehensive nursing intervention based on the Integrated Theory of Health Behavior Change (ITHBC) on patients undergoing peritoneal dialysis with frailty syndrome.
The main questions it aims to answer include:
Can the ITHBC-based comprehensive nursing intervention improve patients' frailty status?
Can the intervention reduce patients' nutritional risk?
Can the intervention enhance patients' exercise self-efficacy, social support, and self-management behaviors?
Researchers will compare the ITHBC-based comprehensive nursing intervention (intervention group) with routine care (control group) to assess the effectiveness of the intervention program.
Participants:
The intervention group receives the ITHBC-based comprehensive nursing intervention (including personalized assessment, knowledge and belief reinforcement, skill development, goal setting and follow-up, and social support promotion) in addition to routine care for 3 months
The control group receives routine care (including admission education, standardized in-hospital health education, and monthly outpatient or telephone follow-up for 3 months)
Data are collected at baseline (T0), 1 month (T1), and 3 months (T2) post-intervention
Outcome measures include: frailty scores, nutritional risk scores, exercise self-efficacy scores, social support scores, and self-management behavior scores
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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;
- •a diagnosis of end-stage renal disease with an estimated glomerular filtration rate of < 15 mL/min/1.73 m² ;
- •currently undergoing peritoneal dialysis with regular follow-up at the peritoneal dialysis clinic;
- •a score of ≥ 3 on the Fried Frailty Phenotype Scale;
- •provision of written informed consent and voluntary participation in this study.
排除标准
- •presence of concurrent severe primary diseases, including malignant tumors;
- •cognitive impairment or a diagnosed mental illness;
- •limb dysfunction that precluded cooperation with the intervention.
结局指标
主要结局
Fried Frailty Phenotype Scale
时间窗: Baseline, Month 1, Month 3
The Fried Frailty Phenotype Scale was developed by Fried et al. in 2001 and is recognized as the most widely used frailty assessment tool in the fields of gerontology and nephrology. This scale includes five components: unintentional weight loss, exhaustion, reduced grip strength, slow walking speed, and decreased physical activity. One point is assigned for each criterion that is met, yielding a total score that ranges from 0 to 5. A score of 0 indicates absence of frailty; scores of 1-2 suggest pre-frailty; and scores of 3 or more indicate frailty. The Cronbach's α coefficient for this scale was reported as 0.868.
Chronic Kidney Disease Self-Management Scale
时间窗: Baseline, Month 1, Month 3
The Chronic Kidney Disease Self-Management Scale (CKD-SM), which was developed by Yu P. and colleagues, evaluates the self-management behavior level of patients undergoing home-based peritoneal dialysis. This scale contains 31 items, which cover four domains: dietary management (12 items), treatment management (9 items), physical activity management (5 items), and psychosocial management (5 items). Each item was scored on a 4-point Likert scale, with response options ranging from "never" to "always" and corresponding scores ranging from 1 to 4. The total score ranges from 31 to 124, with higher scores indicating stronger self-management abilities. The overall Cronbach's α coefficient of this scale was reported as 0.902, and the test-retest reliability was reported as 0.898.
次要结局
- Nutritional Risk Screening Tool(Baseline, Month 1, Month 3)
- Self-Efficacy for Exercise Scale(Baseline, Month 1, Month 3)
- Social Support Rating Scale(Baseline, Month 1, Month 3)
- Laboratory Parameters(Baseline, Month 3)
研究者
Zhi-fen Feng
Doctor
Henan University