Effectiveness of Chronic Kidney Disease Nurse-led Self-management Program (CKD-NLSM): A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change CKD knowledge
研究概览
简要总结
This study aims to develop, implement and evaluate the effectiveness of a theory-driven nurse-led self-management intervention program compared to standard usual care in people with CKD stages 3-4 on CKD knowledge, self-management behavior, self-efficacy and HRQoL using valid and reliable instruments in Malaysia.
详细描述
Patients aged ≥ 18 years with CKD stages 3-4 will be recruited between July 2019 - October 2019. Participants will be randomly allocated into either the intervention (N = 77) or control group (N = 77). The control group will receive standard usual care, while the intervention group will receive standard usual care plus a self-management program delivered by renal nurse educators. The intervention will be guided by social cognitive theory and include group-based educational sessions, CKD booklet and follow-up phone calls. Both groups will be followed for 12 weeks. Data will be analyzed using SPSS version 25. The primary outcomes are improving in knowledge and self-management, while the secondary outcomes are improving in self-confidence, quality of life and clinical outcomes of the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •The inclusion criteria are CKD (stages 3-4), aged ≥ 18 years, could speak, read, and understand Malay language, able to give informed consent, had never participated in any structured education program before, willing to participate in the study and most importantly not expected to start dialysis during the study.
排除标准
- •Participants will be excluded if they had ESRD, were receiving dialysis or were cognitively impaired.
结局指标
主要结局
Change CKD knowledge
时间窗: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
kidney disease knowledge will be measured using a self-report instrument Kidney Disease Knowledge Survey (KiKS). It includes 28 questions, 5 multiple choice type questions and 23 Yes-No questions; none of the questions included an "I don´t know" option. To assess the survey score, 1 point was given to each correct answer and zero to each wrong one. The questionnaire doesn't have domains, and the total score was calculated as the sum of the correct responses to each question divided by the total number of questions, which results in values from 0 to 1 where 1 means the highest level of knowledge.
Change CKD Self-Management Behavior
时间窗: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention)
CKD self-management behavior will be assessed by Self-report instrument Chronic Kidney Disease Self-management (CKD-SM) by (C. C. Lin et al., 2013). CKD-SM instrument contains of 29-item to measure participants' self-management behavior factors. Each item is scored on a Likert scale from 1-4 with 1 being 'never' and 4 'always'. Total scores of the CKD-SM range from 29 to 116 and higher scores indicate better self-management behavior in managing CKD.
次要结局
- Change 24-hour Urine Sodium(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Self-efficacy to manage CKD.(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Protein(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Systolic Blood Pressure(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Creatinine(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Diastolic Blood Pressure(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change Health-related quality of life (HRQoL): Malay KDQOL-36TM(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Urea(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
- Change 24-hour Urine Potassium(Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five week post-intervention))
研究者
Boon-How Chew
Associate Professor
Universiti Putra Malaysia