跳至主要内容
临床试验/NCT04633993
NCT04633993已完成不适用

Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Hypertensive nephropathy self-management instrument (HN-SM)

研究概览

简要总结

This study is a 2-years project. The year 1 project: to assess the effectiveness of implementation of the program in patients with HN. The experimental research design of 2×2 randomized controlled trial with pre and post-testing will be adopted. A total of 70 subjects will be enrolled, and 35 subjects will be randomized into the control group (conventional program) and experimental group (patient-centered self-management program), respectively, using the single-blind design. Firstly, this study will collect the pretest data of the control group and experimental group. The data to be collected include physiological indicators, physical and psychological health, self-efficacy, self-management, and satisfaction, etc. The experimental group will receive the 4-week intervention of program after the pre-test. This study will assess the effectiveness of intervention 1 month later. This study will use generalized estimating equation (GEE) to collect the longitudinal data and test the effectiveness of implementation of program in patients with HN at different time points (after 1, 3, and 6 months). It is expected that the completion of this research project may help improve the effective disease control in the care for patients with HN in Taiwan and improve self-management of disease. Hopefully, the incidence of patients with dialysis can be significantly reduced and the progression into ESRD in patients can be effectively delayed. Moreover, this study also intends propose specific suggestions about the care of patients with HN for industry, government, and academia.

详细描述

Since population aging is accompanied by chronic diseases. Hypertension is a type of chronic disease, and poor to control the symptoms of hypertension may accelerate the progression of renal function into hypertensive nephropathy (HN) and ultimately lead to dialysis. 2017 annual report on kidney disease in Taiwan published by The Taiwan Society of Nephrology showed that among the comorbidities experienced by new patients before the 1year dialysis, hypertension ranked the first (89.5%). In Taiwan, the prevalence and incidence of end-stage renal disease (ESRD) both are ranked high in the world, which has an impact on the aspects of individual, family, society, etc. and jeopardizes the financial situation of the government's national health insurance. Therefore, in order to effectively reduce the incidence of ESRD and delay the progression of HN, the implementation of a patient-centered self-management program may effectively reduce medical costs and improve patients' quality of life. This study is a 2-years project. The year 1 project to assess the effectiveness of implementation of the program in patients with HN. The experimental research design of 2×2 randomized controlled trial with pre and post-testing will be adopted. A total of 70 subjects will be enrolled, and 35 subjects will be randomized into the control group (conventional program) and experimental group (patient-centered self-management program), respectively, using the single-blind design. Firstly, this study will collect the pretest data of the control group and experimental group. The data to be collected include physiological indicators, physical and psychological health, self-efficacy, self-management, and satisfaction, etc. The experimental group will receive the 4-week intervention of program after the pre-test. This study will assess the effectiveness of intervention 1 month later. This study will use G power statistical analysis to calculate the sample size and use SPSS/Windows 20.0 for recording and statistical analysis. For the statistical analysis methods, this study will use repeated measure ANOVA to analyze the effectiveness of intervention. The year 2 project is to extend the year 1 research project. This study will use generalized estimating equation (GEE) to collect the longitudinal data and test the effectiveness of implementation of program in patients with HN at different time points (after 1, 3, and 6 months). It is expected that the completion of this research project may help improve the effective disease control in the care for patients with HN in Taiwan and improve self-management of disease. Hopefully, the incidence of patients with dialysis can be significantly reduced and the progression into ESRD in patients can be effectively delayed. Moreover, this study also intends propose specific suggestions about the care of patients with HN for industry, government, and academia.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hypertensive nephropathy and chronic kidney disease stage 3b to
  • Clear consciousness and could communicate in Chinese and Taiwanese
  • Age 20 years old the above.

排除标准

  • End-stage kidney disease who have undergone dialysis treatment (hemodialysis, peritoneal dialysis)
  • Clinical diagnosis of diabetic nephropathy
  • Diagnosed as mental illness (severe depression, schizophrenia) and cognitive dysfunction

结局指标

主要结局

Hypertensive nephropathy self-management instrument (HN-SM)

时间窗: 1st month, 3th month, and 6th month after recruited.

The HN-SM: This scale is measured for evaluating the self-management of patients with hypertensive nephropathy in the past week. This scale is composed of 29 items in total, including 4 subscales: self-integration (10 questions), problem-solving (10 questions), seeking social support (5 questions), and compliance behavior (4 questions). This scale used four-point Likert scale for scoring: 1 point for "never", 2 point for "sometimes", 3 point for "often", and 4 point for "always". The total score ranged from 29 to 116 points. The reliability and validity of Cronbach'α was 0.77-0.92. The higher the total score, the better the patients with hypertensive nephropathy self-management.

次要结局

  • World Health Organization-5 Well Being Index (WHO-5)(1st month, 3th month, and 6th month after recruited.)
  • The hypertensive nephropathy self-efficacy instrument (HN-SE)(1st month, 3th month, and 6th month after recruited.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Chen Lee

RN, PhD, Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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