Preference of Life-Sustaining Treatment Among Patients With End Stage Renal Disease

November 12, 2023 updated by: National Taiwan University Hospital
Although patients with kidney disease can rely on dialysis to prolong their lives, the complexity of the disease, the variability of the course of the disease, and the uncertainty of the prognosis often delay the discussion of issues at the end of life, and the deterioration of the condition often makes it impossible for the patient to express clearly or rationally. Treatment thoughts or preferences. Sufficient time is needed to think and discuss issues related to life treatment. Discuss with patients as soon as possible to help draw up end-of-life care plans, help patients realize end-of-life care preferences, assist family members to make complex treatment decisions, and alleviate medical providers' moral distress. Domestic life-sustaining treatment research is mostly signed by DNR for cancer patients and retrospective investigation of medical records, and seldom focuses on kidney disease patients and life-sustaining treatment survey preferences other than DNR content. This study sought to understand patients with kidney disease's preferences for life-sustaining care during disease progression, and to understand whether prognostic perceptions, symptom distress, dementia, and decision conflict affect patients' preferences. Pre-collected convenient sampling is expected to include 200 patients diagnosed with chronic kidney disease stage 5 or end-stage renal disease, including patients who have received regular dialysis. The survey will be conducted with a single questionnaire. There are five questionnaires, including: demographic characteristics, chronic kidney disease prognosis cognition And life-support treatment information questionnaire, short-form recall symptom assessment scale, loss of memory scale and decision-making conflict scale; after the researcher explains, the patient fills in by himself or the researcher fills in after the patient answers. It is expected that the results of the study will help clinical practitioners to understand the changes in the management of medical care for kidney disease patients when the disease worsens and assist in the management of patients' medical care, echoing the importance of advancing medical care planning in this population, for the future development of kidney disease A reference for care guidelines for debilitated patients, thereby improving care quality and satisfaction.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chan-Shiuan Kuo
  • Phone Number: +886-2-23123456 Ext. 262489
  • Email: r785380@gmail.com

Study Locations

      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan
        • Completed
        • National Taipei University of Nursing and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.

Description

Inclusion Criteria:

  1. Over 20 years old.
  2. Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
  3. Those who have normal cognitive function (such as: able to read newspapers and magazines, and communicate with others), and can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

  1. Severe cognitive impairment or visual or hearing impairment that makes it impossible to answer questions.
  2. Critically ill patients.
  3. Patients with chronic mental illness or their related diagnosis records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference for end-of-life life-sustaining treatment for patients with end-stage renal disease
Time Frame: one year
This study aimed to investigate end-stage renal disease treatment and end-of-life life-sustaining treatment preferences in patients with renal failure. Life-sustaining treatment preferences include cardiac resuscitation, endotracheal intubation, mechanical ventilation, blood transfusion, antibiotics, and artificial nutrition and fluids. And life support treatment preference is divided into three aspects: preference choice, clear understanding, and certainty for preference data investigation: (1) For each life support treatment preference choice, "absolutely", "maybe", "may not" " Never"; (2) Are you aware of your preferences for each life-sustaining treatment clearly enough to select a "yes" and "no" option; (3) Are you confident in choosing each life-sustaining treatment? "Yes" and "No" options.
one year
The influencing factors of life-sustaining treatment preference in patients with end-stage renal disease
Time Frame: one year
The life-sustaining treatment that patients with ESRD are willing to receive at the end of life will be affected by demographic characteristics, that is, collecting patients' sex, age, time of kidney disease diagnosis, frequency of dialysis, religion, occupational status and laboratory reports; prognostic perception will ask patients Self-prognosis expectations are less than 5 years, 5 to 10 years, greater than 10 years and uncertain; MSAS-SF is used to investigate the symptoms of patients within a week, and can also be compared with cancer and other diseases; Demoralization Scale-Mandarin Version is used to describe the degree of pain in the past two weeks, describe the pain of the patient, judge the severity of the patient's low morale, predict suicidal behavior, evaluate the quality of life and screen the diagnosis of depression but face survival crisis and lose the meaning of life of patients.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chan-Shiuan Kuo, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

height and weight,BUN,Cre,eGFR, pH,HCO3,CO2,HB,WBC,Plt,CRP,Na,K,Ca,P,Alb,HBA1c,Cardiac ultrasound,Cardiac Catheterization,computed tomography

IPD Sharing Time Frame

starting 2 months after publication

IPD Sharing Access Criteria

File and encode the data through Microsoft Excel conversion, and use SPSS 22.0 software for data analysis.

Descriptive statistics describe the distribution of data, and inferential statistics set a 95% confidence interval, and a p value less than 0.05 is considered significant. Chi-square test (Chi-square) and ANOVA were used to detect whether the patient's preference for life-sustaining treatment was related to the basic demographic status, dialysis treatment situation, prognosis cognition, symptom distress and dementia. Age, duration of renal disease, ADL, frequency of cardiopulmonary resuscitation and chance of self-conscious disease recovery were tested by independent sample t test. Pearson's product-difference correlation coefficient describes the relationship between each variable and life-sustaining treatment preference, and logistic regression predicts important factors that affect patients' life-sustaining treatment preference.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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