The Effect of a Nurse-Led Needs-Based Dialysis Self-Management Program on Dialysis-Related Distress in Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
研究概览
简要总结
Hemodialysis patients may experience dialysis-related distress due to long-term treatment requirements, dietary and fluid restrictions, medication use, vascular access problems, dialysis-related symptoms, and psychosocial challenges. Nurse-led self-management programs may help patients improve dialysis self-management, reduce distress, and support treatment adherence.
This study aims to evaluate the effect of a nurse-led needs-based dialysis self-management program on dialysis-related distress in patients receiving hemodialysis. The study will be conducted as a single-center, two-arm, parallel-group, randomized controlled trial. A total of 100 adult hemodialysis patients will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.
Participants in the intervention group will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. Participants in the control group will continue routine hemodialysis care. Data will be collected at baseline, 6 weeks, and 18 weeks. The primary outcome is dialysis-related distress. Secondary outcomes include illness and treatment uncertainty, treatment adherence, and clinical adherence indicators.
详细描述
The intervention is a structured, non-invasive, education- and counseling-based behavioral nursing intervention. The nurse-led needs-based dialysis self-management program aims to improve self-management skills, reduce dialysis-related distress, decrease illness and treatment uncertainty, and support treatment adherence.
The program will be delivered over 6 weeks through weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes two components: standard core education and needs-based individualized counseling. Standard core education will be delivered to all participants in the intervention group. Individualized counseling will be guided by participants' baseline dialysis-related distress, illness and treatment uncertainty, treatment adherence, and clinical indicators.
The intervention content includes the hemodialysis process and individual needs assessment, fluid management and interdialytic weight control, diet and potassium/phosphorus management, medication adherence and treatment continuity, symptom and distress management, coping with treatment uncertainty, and development of a sustainable self-management plan. Intervention fidelity will be monitored using a standardized session checklist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and intervention providers cannot be masked due to the nature of the behavioral nursing intervention. Outcome assessment and data analysis will be conducted with group codes masked.
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
- •Aged 18 years or older
- •Receiving hemodialysis treatment for at least 3 months
- •Receiving hemodialysis treatment at least twice per week
- •Able to read and understand Turkish
- •Conscious and able to communicate
- •Providing written informed consent
排除标准
- •Advanced cognitive impairment
- •Active psychiatric crisis
- •History of major surgery or acute severe illness within the last 3 months
- •Planned kidney transplantation in the near future
- •Serious physical or communication problems that may prevent regular participation in the intervention sessions
- •Concurrent participation in another structured education or psychosocial intervention program
研究组 & 干预措施
Routine Hemodialysis Care
Participants in this arm will continue to receive routine hemodialysis care. No additional structured education or counseling program will be provided by the research team during the study period.
干预措施: Routine Hemodialysis Care (Behavioral)
Nurse-Led Needs-Based Dialysis Self-Management Program
Participants in this arm will receive a 6-week nurse-led needs-based dialysis self-management program in addition to routine hemodialysis care. The program includes weekly face-to-face individual sessions lasting approximately 40 to 45 minutes. The intervention includes standard core education and needs-based individualized counseling focused on fluid management, diet, medication adherence, symptom and distress management, treatment uncertainty, and sustainable dialysis self-management.
干预措施: Nurse-Led Needs-Based Dialysis Self-Management Program (Behavioral)
结局指标
主要结局
Dialysis-Related Distress Assessed by the Hemodialysis Distress Thermometer
时间窗: Baseline, 6 weeks, and 18 weeks
Dialysis-related distress will be assessed using the Hemodialysis Distress Thermometer. The instrument includes a distress barometer scored from 0 to 10, where 0 indicates no distress and 10 indicates extreme distress. Higher scores indicate higher perceived dialysis-related distress. The instrument also includes a 40-item problem checklist scored from 0 to 40, where higher scores indicate a greater number of distress-related problems.
次要结局
- Illness and Treatment Uncertainty Assessed by the Uncertainty in Chronic Dialysis Treatment Scale(Baseline, 6 weeks, and 18 weeks)
- Treatment Adherence Assessed by the End-Stage Renal Disease Adherence Questionnaire(Baseline, 6 weeks, and 18 weeks)