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

Primary Purpose

Hypertensive Nephropathy, Self-management, Self-efficacy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PCSMP
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Nephropathy focused on measuring hypertension, hypertensive nephropathy, chronic kidney disease, end-stage kidney disease,, patient-centered,, self-management program

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardinal Tien Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PCSMP

Usual Care

Arm Description

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).

Routine care.

Outcomes

Primary Outcome Measures

Hypertensive nephropathy self-management instrument (HN-SM)
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.

Secondary Outcome Measures

World Health Organization-5 Well Being Index (WHO-5)
WHO-5: This scale is measured for evaluating the physical and mental health status of patients with hypertensive nephropathy in the past week. This scale is a five-item questionnaire. This scale used six-point Likert scale for scoring: The scoring included 0 point for "at no time", 1 point for "sometimes", 2 point for "less than half time", 3 point for "more than half a time", 4 point for "most of the time", and 5 point for "all of the time". The total score ranges from 0 to 25 points. The Cronbach's α value of this scale is .87. Patients whose total score is lower than 13 points or whose answer to any of the 5 items is 0 to 1 point are recommended to receive the test of severe depression scale.
The hypertensive nephropathy self-efficacy instrument (HN-SE)
HN-SE: This study used this scale to test the level of self-confidence in disease self-management of patients with hypertensive nephropathy in the past week.This scale is a 25-item questionnaire. This scale used four-point Likert scale for scoring: The scoring included 0 point for "totally unsure" to 10 point for "very sure". The total score ranged from 0 to 250 points. The reliability and validity of Cronbach'α was 0.84-0.90. The higher the total score, the higher the level of self-confidence control of a disease self-management of patients with hypertensive nephropathy.

Full Information

First Posted
October 23, 2020
Last Updated
April 6, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cardinal Tien Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04633993
Brief Title
Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy
Official Title
Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Cardinal Tien Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Nephropathy, Self-management, Self-efficacy, Mental Health Wellness 1
Keywords
hypertension, hypertensive nephropathy, chronic kidney disease, end-stage kidney disease,, patient-centered,, self-management program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCSMP
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Routine care.
Intervention Type
Behavioral
Intervention Name(s)
PCSMP
Other Intervention Name(s)
Usual Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Hypertensive nephropathy self-management instrument (HN-SM)
Description
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.
Time Frame
1st month, 3th month, and 6th month after recruited.
Secondary Outcome Measure Information:
Title
World Health Organization-5 Well Being Index (WHO-5)
Description
WHO-5: This scale is measured for evaluating the physical and mental health status of patients with hypertensive nephropathy in the past week. This scale is a five-item questionnaire. This scale used six-point Likert scale for scoring: The scoring included 0 point for "at no time", 1 point for "sometimes", 2 point for "less than half time", 3 point for "more than half a time", 4 point for "most of the time", and 5 point for "all of the time". The total score ranges from 0 to 25 points. The Cronbach's α value of this scale is .87. Patients whose total score is lower than 13 points or whose answer to any of the 5 items is 0 to 1 point are recommended to receive the test of severe depression scale.
Time Frame
1st month, 3th month, and 6th month after recruited.
Title
The hypertensive nephropathy self-efficacy instrument (HN-SE)
Description
HN-SE: This study used this scale to test the level of self-confidence in disease self-management of patients with hypertensive nephropathy in the past week.This scale is a 25-item questionnaire. This scale used four-point Likert scale for scoring: The scoring included 0 point for "totally unsure" to 10 point for "very sure". The total score ranged from 0 to 250 points. The reliability and validity of Cronbach'α was 0.84-0.90. The higher the total score, the higher the level of self-confidence control of a disease self-management of patients with hypertensive nephropathy.
Time Frame
1st month, 3th month, and 6th month after recruited.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chen Lee, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardinal Tien Hospital
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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30427110
Citation
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Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy

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