Chronic Kidney DiseasesNCT06068660
Effects of a Goal-Oriented Care Interventions
A study testing The Goal-Oriented Care program and The routine health education in people with Chronic Kidney Diseases and Acute on Chronic Renal Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Acute on Chronic Renal Failure, Acute Kidney Injury
- What is being tested?
- The Goal-Oriented Care program and The routine health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2021to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Goal-Oriented Care on Health Outcome in Patients With Unplanned Dialysis After Discharge
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.
Read the 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.
- Being tested
- The Goal-Oriented Care program, The routine health education
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Goal-Oriented Care programBehavioural
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.
The routine health educationBehavioural
The control group received routine education, which consisted of oral education and provision of educational pamphlets by nurses during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | 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. Receives: Behavioral: The Goal-Oriented Care program; Behavioral: The routine health education |
| The control group | Active comparator | The control group received routine health education Receives: Behavioral: The routine health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurements
Blood pressure measurements were performed by dialysis technicians using regularly maintained blood pressure monitors.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start6 Oct 2021
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, Principal investigator, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068660
- Sponsor's protocol ID
- 202101313A3
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Goal-Oriented Care on Health Outcome in Patients With Unplanned Dialysis After Discharge
- ClinicalTrials.gov ID
- NCT06068660
- Acronym / sponsor ID
- 202101313A3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Behavioral: The Goal-Oriented Care program, Behavioral: The routine health educationThe 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 | Active comparator | Behavioral: The routine health educationThe control group received routine health education |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Goal-Oriented Care programThe 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. | Behavioural | The experimental group |
| The routine health educationThe control group received routine education, which consisted of oral education and provision of educational pamphlets by nurses during hospitalization. | Behavioural | The control group, The experimental group |
Primary outcome
Blood pressure measurements
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.
Blood pressure measurements were performed by dialysis technicians using regularly maintained blood pressure monitors.
Percentage of interdialytic weight gain (IDWG%) during dialysis
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.
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
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang-Tang Hsieh principal investigator
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Goal-Oriented Care program and The routine health education in people with Chronic Kidney Diseases and Acute on Chronic Renal Failure, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurements (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.