Clinical trial NCT06068660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Acute on Chronic Renal Failure
Acute Kidney Injury
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

The exclusion criteria were a history of psychiatric illness, any active infection and inability to communicate or understand the educational process.

Primary outcomes:
measure: Blood pressure measurements
timeFrame: 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.
measure: Percentage of interdialytic weight gain (IDWG%) during dialysis
timeFrame: 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.
measure: The hemodialysis self-management scale 20 items and measures the execution of problem-solving, emotional management, self-care, and partner relationships
timeFrame: 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.
measure: The physical component summary (PCS) and mental component summary (MCS) Quality of Life
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ChangGungMH
Study officials:
affiliation: Institutional Review Board Chang Gung Medical Foundation
name: Tsang-Tang Hsieh
role: PRINCIPAL_INVESTIGATOR
References: