eHealth Based Self-management Intervention for Chronic Kidney Disease Care in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument from baseline to 3, 6 and 9 months after randomization
研究概览
简要总结
The purpose of this study is to develop an evidence-based tailored eHealth self-management intervention for patients with chronic kidney disease in China, and test the impact on implementation and effectiveness of interventions.
详细描述
Interventions that support disease self-management (further referred to as 'self-management interventions') can have a significant impact on the health and quality of life of patients suffering from chronic conditions in general and chronic kidney disease (CKD) patients in specific. In the last decade, the use of electronic health (eHealth) technology in self-management interventions has become more and more popular. EHealth-based self-management interventions have been shown to improve health-related outcomes, such as blood pressure (BP) control and medication adherence, and found to be feasible and acceptable for CKD patients and care professionals. Hence, the use of eHealth self-management interventions for CKD patients has become increasingly popular. Knowledge of the implementation and effectivity of such interventions in China and other developing countries is, however, still lacking. Researchers from the Leiden University Medical Center (LUMC) developed 'Medical Dashboard', an eHealth intervention to help support and involve CKD patients in their disease self-management. We aim to tailor the evidence-based Dutch intervention 'Medical Dashboard' to the Chinese context and evaluate its implementation process and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patients: (1) aged over 18 years old; (2) diagnosis of chronic kidney disease; (3) Chinese speaking.
- •Health care providers who work in the Department of Nephrology
排除标准
- •Individuals unable to participate due to physical or mental disabilities.
- •Individuals unable to write or read.
结局指标
主要结局
Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument from baseline to 3, 6 and 9 months after randomization
时间窗: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)
The Chronic Kidney Disease Self-Management (CKD-SM) instrument with 29 items uses a four-point likert scale ranging from 1 (never) to 4 (always) to measure subjects' self-management behavior. Possible scores range from 29 to 116 points, with higher scores indicating better self-management behavior
Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument
时间窗: 0 month (baseline), 9 months after randomisation (endpoint)
The Chronic Kidney Disease Self-Management (CKD-SM) instrument with 29 items uses a four-point likert scale ranging from 1 (never) to 4 (always) to measure subjects' self-management behavior. Possible scores range from 29 to 116 points, with higher scores indicating better self-management behavior
次要结局
- Change of blood pressure from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Change of body weight from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomization, 6 months after randomization, 9 months after randomization (endpoint))
- Change of glomerular filtration rate from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Change of serum creatinine from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Change of number of complications patients have from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Change of serum albumin from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Hospital admission(9 months after randomisation (endpoint))
- Change of cost-benefit data from 3 months after randomisation to 9 months after randomisation(3 months after randomisation, 9 months after randomisation (endpoint))
- Change of chronic kidney disease self-efficacy using Chronic Kidney Disease Self-efficacy (CKD-SE) scale from baseline to 3, 6 and 9 months after randomization(0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint))
- Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ) from baseline to 9 months after randomization(0 month (baseline), 9 months after randomisation (endpoint))
- Change of chronic kidney disease quality of life using the Kidney Disease Quality of Life 36-item short-form survey (KDQOL-36) from baseline to 9 months after randomization(0 month (baseline), 9 months after randomisation (endpoint))
- Change of chronic kidney disease anxiety and depression status using the Hospital Anxiety and Depression Scale (HADS) from baseline to 3, and 9 months after randomization(0 month (baseline), 3 months after randomisation, 9 months after randomisation (endpoint))
- Change of healthcare utilisation from 3 months after randomisation to 9 months after randomisation(3 months after randomisation, 9 months after randomisation (endpoint))
- The proportion of chronic kidney disease patients and care professionals reached by the implementation of interventions(Throughout the 9-month trial)
- The number of implementation completion tasks completed(Throughout the 9-month trial)
- The number of chronic kidney disease patients' and care providers' use of the intervention(Throughout the 9-month trial)
- Change of number of complications patients(0 month (baseline), 9 months after randomisation (endpoint))
- Change of chronic kidney disease self-efficacy using Chronic Kidney Disease Self-efficacy (CKD-SE) scale(0 month (baseline), 9 months after randomisation (endpoint))
- Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ)(0 month (baseline), 9 months after randomisation (endpoint))
- Change of chronic kidney disease anxiety and depression status using the Hospital Anxiety and Depression Scale (HADS)(0 month (baseline), 9 months after randomisation (endpoint))
研究者
HongxiaShen
PhD, Associate Professor
Leiden University Medical Center