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Effects of a Goal-Oriented Care Interventions

Primary Purpose

Chronic Kidney Diseases, Acute on Chronic Renal Failure, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The Goal-Oriented Care program
The routine health education
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients who received unplanned dialysis during hospitalization; aged between 20 and 80 years; not undergoing renal replacement therapy before recruitment; alert consciousness status and ability to communicate; ability to perform self-management behaviors. Exclusion Criteria: The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process.

Sites / Locations

  • ChangGungMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The experimental group

The control group

Arm Description

The experimental group during hospitalization additionally received 40 minutes of one-on-one education three times a week for three weeks, as the Goal-Oriented Care program for 6 hours in total, followed by telephone sessions of 20 minutes every month for six months post-discharge.

The control group received routine health education

Outcomes

Primary Outcome Measures

Blood pressure measurements
Blood pressure measurements were performed by dialysis technicians using regularly maintained blood pressure monitors.
Percentage of interdialytic weight gain (IDWG%) during dialysis
Interdialytic weight gain percentage (IDWG%) was calculated as the difference between the weight at the start of dialysis and the weight after the previous dialysis session, divided by the dry weight set by the physician, expressed as a percentage.
The hemodialysis self-management scale 20 items and measures the execution of problem-solving, emotional management, self-care, and partner relationships
The self-administered Chinese version of the Hemodialysis Self-Management Scale, developed by Song and Lin (Song & Lin 2009), was used. It consists of 20 items and measures the execution of problem-solving, emotional management, self-care, and partner relationships in the daily lives of dialysis patients. Responses were rated on a Likert scale ranging from "never" (scored as 1) to "always" (scored as 4). The total score ranges from 20 to 80, with higher scores indicating better self-management levels.
The physical component summary (PCS) and mental component summary (MCS) Quality of Life
The Taiwan version of the 36-item Medical Outcome Study Short Form Health Survey (SF-36), translated by Lu et al. in 2003, was used to assess patients' physical and mental health-related quality of life within the past 30 days. The physical component summary (PCS) includes measurements of bodily functioning, physical role, pain, and general health. The mental component summary (MCS) includes measurements of vitality, emotional role, social functioning, and mental health. Scores were obtained through questionnaire responses and converted based on the SF-36 manual, with scores ranging from 0 to 100. Higher scores indicate better quality of life.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2023
Last Updated
October 11, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06068660
Brief Title
Effects of a Goal-Oriented Care Interventions
Official Title
Effects of a Goal-Oriented Care on Health Outcome in Patients With Unplanned Dialysis After Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial 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 was a clinical trial. This study aimed to evaluate the effects of Goal-Oriented Care intervention on blood pressure, percentage of interdialytic weight gain, self-management behaviors, and quality of life in hospitalized patients with unplanned dialysis at three and six-months post-discharge. This study was an experimental design in a medical center in Southern Taiwan. A cluster sample method was selected for each two wards from four nephrology wards and was randomly assigned to the experimental and control groups. The enrolled patients were assigned to the experimental and control groups according to different wards' admission. The inclusion criteria were: (1) patients who received unplanned dialysis during hospitalization; (2) aged between 20 and 80 years; (3) not undergoing renal replacement therapy before recruitment; (4) alert consciousness status and ability to communicate; (5) ability to perform self-management behaviors. The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process. Each group consisted of 46 participants. Both groups received routine health education. However, the experimental group during hospitalization additionally received 40 minutes of one-on-one education three times a week for three weeks, as the Goal-Oriented Care program for 6 hours in total, followed by telephone sessions of 20 minutes every month for six months post-discharge. On receiving the third dialysis, baseline data including self-report questionnaires assessed participants' demographic and disease characteristics and medical record reports for blood pressure and percentage of interdialytic weight gain were collected. A week after discharge, self-management behaviors and quality of life baseline data were assessed using self-reported questionnaires and these were followed up at three and six-months post-discharge, which then also included blood pressure and percentage of interdialytic weight gain.Generalized estimating equations were used to assess changes amounts in each outcome variable from the baseline to three months and six-months post-discharge between two groups.
Detailed Description
On receiving the third dialysis, baseline data including self-report questionnaires assessed participants' demographic and disease characteristics and medical record reports for blood pressure and percentage of interdialytic weight gain were collected. A week after discharge, self-management behaviors and quality of life baseline data were assessed using self-reported questionnaires and these were followed up at three and six-months post-discharge, which then also included blood pressure and percentage of interdialytic weight gain. All data were analyzed using the computer-based statistical software package SPSS, version 20.0. Descriptive statistics were calculated to examine the distribution of the study variables as mean, standard deviation and percentage among participants. Inferential statistics included the chi-square test, independent two-sample t-test, and paired sample t-test. Generalized estimating equations were used to assess changes amounts in each outcome variable from the baseline to three months and six-months post-discharge between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Acute on Chronic Renal Failure, Acute Kidney Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental group
Arm Type
Experimental
Arm Description
The experimental group during hospitalization additionally received 40 minutes of one-on-one education three times a week for three weeks, as the Goal-Oriented Care program for 6 hours in total, followed by telephone sessions of 20 minutes every month for six months post-discharge.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
The control group received routine health education
Intervention Type
Behavioral
Intervention Name(s)
The Goal-Oriented Care program
Intervention Description
The Goal-Oriented Care Interventions The GOC intervention included the following steps: respecting the participant's values in setting goals, considering direct and indirect factors influencing the goals, communicating and setting goals, implementing goal-oriented strategies, and evaluating goals while adjusting the content of the strategies.
Intervention Type
Behavioral
Intervention Name(s)
The routine health education
Intervention Description
The control group received routine education, which consisted of oral education and provision of educational pamphlets by nurses during hospitalization.
Primary Outcome Measure Information:
Title
Blood pressure measurements
Description
Blood pressure measurements were performed by dialysis technicians using regularly maintained blood pressure monitors.
Time Frame
Baseline measurements were taken in a supine position during the third hemodialysis session and recorded systolic and diastolic blood pressures. Follow-up measurements were taken before each hemodialysis session at three and six months after discharge.
Title
Percentage of interdialytic weight gain (IDWG%) during dialysis
Description
Interdialytic weight gain percentage (IDWG%) was calculated as the difference between the weight at the start of dialysis and the weight after the previous dialysis session, divided by the dry weight set by the physician, expressed as a percentage.
Time Frame
The average of all measurements taken during the two weeks after the third dialysis session served as the baseline, while the average of all measurements taken every three months during the three- and six-month follow-up periods was recorded.
Title
The hemodialysis self-management scale 20 items and measures the execution of problem-solving, emotional management, self-care, and partner relationships
Description
The self-administered Chinese version of the Hemodialysis Self-Management Scale, developed by Song and Lin (Song & Lin 2009), was used. It consists of 20 items and measures the execution of problem-solving, emotional management, self-care, and partner relationships in the daily lives of dialysis patients. Responses were rated on a Likert scale ranging from "never" (scored as 1) to "always" (scored as 4). The total score ranges from 20 to 80, with higher scores indicating better self-management levels.
Time Frame
Baseline data collected from participants during their hospitalization after the third hemodialysis session. Follow-up data on self-management behaviors, and quality of life questionnaires were collected at three months and six months after discharge.
Title
The physical component summary (PCS) and mental component summary (MCS) Quality of Life
Description
The Taiwan version of the 36-item Medical Outcome Study Short Form Health Survey (SF-36), translated by Lu et al. in 2003, was used to assess patients' physical and mental health-related quality of life within the past 30 days. The physical component summary (PCS) includes measurements of bodily functioning, physical role, pain, and general health. The mental component summary (MCS) includes measurements of vitality, emotional role, social functioning, and mental health. Scores were obtained through questionnaire responses and converted based on the SF-36 manual, with scores ranging from 0 to 100. Higher scores indicate better quality of life.
Time Frame
Baseline data collected from participants during their hospitalization after the third hemodialysis session. Follow-up data on self-management behaviors, and quality of life questionnaires were collected at three months and six months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who received unplanned dialysis during hospitalization; aged between 20 and 80 years; not undergoing renal replacement therapy before recruitment; alert consciousness status and ability to communicate; ability to perform self-management behaviors. Exclusion Criteria: The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsang-Tang Hsieh
Organizational Affiliation
Institutional Review Board Chang Gung Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChangGungMH
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Goal-Oriented Care Interventions

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