Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Norther Private Collage of Nursing
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Functional performance (KPS)
概览
简要总结
This randomized controlled clinical trial was conducted to evaluate the effectiveness of an integrated nurse-led multidimensional intervention on functional performance, sleep quality, and psychological distress among patients undergoing maintenance hemodialysis in Egypt. A total of 220 patients were randomly assigned to either an intervention group receiving structured nursing care or a control group receiving routine dialysis care. Outcomes were assessed at baseline, 12 weeks, and 6 months. The primary objective was to determine whether the intervention improved functional trajectories, while secondary objectives included evaluating its effects on sleep quality and psychological distress.
详细描述
End-stage renal disease (ESRD) patients receiving maintenance hemodialysis frequently experience progressive functional decline, impaired sleep quality, and high levels of anxiety and depression. Despite routine dialysis management, these multidimensional burdens remain insufficiently addressed within standard care in Egyptian renal units.
This parallel-group, single-blind randomized controlled trial was conducted in two tertiary governmental hemodialysis centers in Egypt between March 2024 and January 2025. Eligible participants were adults diagnosed with ESRD and receiving hemodialysis for at least six months.
Following baseline assessment, participants (N = 220) were randomly allocated in a 1:1 ratio to:
Intervention group (n = 110): Received a 12-week integrated nurse-led care program including intradialytic functional training, structured sleep optimization counseling, and brief psychological support strategies.
Control group (n = 110): Received routine dialysis care without additional structured interventions.
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
- None
盲法说明
Single-blind design: Outcome assessors were blinded to group allocation to reduce measurement bias.
Participants and intervention nurses were not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with end-stage renal disease (ESRD)
- •Receiving hemodialysis ≥ 6 months
- •Aged ≥ 18 years to 55 years
- •Clinically stable during the previous 3 months
- •Able to communicate in Arabic
- •Provided written informed consent
排除标准
- •Cognitive impairment or severe psychiatric disorder
- •Terminal comorbid condition
- •Hospitalization within the previous month
- •Participation in another interventional study
研究组 & 干预措施
study group
Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program such as exercise training , relaxation technique, emotional support , delivered twice weekly during dialysis sessions (30-40 minutes each), including:
Functional training: Low-to-moderate intradialytic exercises, progressive mobility training, and energy conservation strategies.
Sleep optimization: Sleep hygiene education, relaxation techniques, and behavioral sleep scheduling.
Psychological support: Brief cognitive-behavioral strategies, emotional coping skills, and motivational interviewing.
干预措施: Arm Description: Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program, delivered twice weekly during dialysis sessions (30-40 minutes each), including: Fun (Other)
control group
placebo comparator: Participants received standard routine dialysis care such as medical treatment , drug therapy only
干预措施: Arm Description: Intervention Group: Participants received a 12-week integrated nurse-led multidimensional program, delivered twice weekly during dialysis sessions (30-40 minutes each), including: Fun (Other)
结局指标
主要结局
Functional performance (KPS)
时间窗: 6 month
The Karnofsky Performance Status (KPS) scale is a widely used measure of overall functional ability and independence in patients with chronic illnesses. Scores range from 0 to 100, where higher scores indicate better functional capacity: 100: Normal, no complaints, no evidence of disease 80-90: Able to carry on normal activity with minor signs/symptoms 50-70: Requires varying degrees of assistance
次要结局
未报告次要终点
研究者
Amal Hashem
Associate professor
Norther Private Collage of Nursing