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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertensive Nephropathy Self-management Self-efficacy Mental Health Wellness 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PCSMP

Patient-centered self-management program for patients with hypertensive nephropathy into 4 units, including: Unit 1: hypertensive nephropathy brief introduction and complications. Unit 2: dietary precautions for patients with hypertensive nephropathy. Unit 3: medication treatments for patients with hypertensive nephropathy. Unit 4: the content included stress management (emotional control, spiritual support). This program was implemented in small groups with 5-10 patients. This study used patient-centered self-management group activity manual as the tool. The group activities with 4 units lasting for 400 minutes were expected to be designed. The group activities were expected to last for 4 weeks and be implemented once per week and 100 minutes per time (including: 90 minutes of group discussion and 5-10 minutes of video-waring).

Group Type EXPERIMENTAL

PCSMP

Intervention Type BEHAVIORAL

This study divided the patient-centered self-management manual for patients with hypertensive nephropathy into 4 units, including: Unit 1: hypertensive nephropathy brief introduction and complications. Unit 2: dietary precautions for patients with hypertensive nephropathy. Unit 3: medication treatments for patients with hypertensive nephropathy. Unit 4: the content included stress management (emotional control, spiritual support). This program was implemented in small groups with 5-10 patients. This study used patient-centered self-management group activity manual as the tool. The group activities with 4 units lasting for 400 minutes were expected to be designed. The group activities were expected to last for 4 weeks and be implemented once per week and 100 minutes per time (including: 90 minutes of group discussion and 5-10 minutes of video-waring).

Usual Care

Routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PCSMP

This study divided the patient-centered self-management manual for patients with hypertensive nephropathy into 4 units, including: Unit 1: hypertensive nephropathy brief introduction and complications. Unit 2: dietary precautions for patients with hypertensive nephropathy. Unit 3: medication treatments for patients with hypertensive nephropathy. Unit 4: the content included stress management (emotional control, spiritual support). This program was implemented in small groups with 5-10 patients. This study used patient-centered self-management group activity manual as the tool. The group activities with 4 units lasting for 400 minutes were expected to be designed. The group activities were expected to last for 4 weeks and be implemented once per week and 100 minutes per time (including: 90 minutes of group discussion and 5-10 minutes of video-waring).

Intervention Type BEHAVIORAL

Other Intervention Names

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Usual Care

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypertensive nephropathy and chronic kidney disease stage 3b to 5.
* Clear consciousness and could communicate in Chinese and Taiwanese
* Age 20 years old the above.

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No