- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878171
Preference of Life-Sustaining Treatment Among Patients With End Stage Renal Disease
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chan-Shiuan Kuo
- Phone Number: +886-2-23123456 Ext. 262489
- Email: r785380@gmail.com
Study Locations
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-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chun-Fu Lai, M.D.
- Phone Number: 63921 +886-2-23123456
- Email: s821052@gmail.com
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Taipei, Taiwan
- Completed
- National Taipei University of Nursing and Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 20 years old.
- 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.
- 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:
- Severe cognitive impairment or visual or hearing impairment that makes it impossible to answer questions.
- Critically ill patients.
- Patients with chronic mental illness or their related diagnosis records.
Study Plan
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.
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one year
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: Chan-Shiuan Kuo, National Taiwan University Hospital
Publications and helpful links
General Publications
- Saeed F, Sardar M, Rasheed K, Naseer R, Epstein RM, Davison SN, Mujtaba M, Fiscella KA. Dialysis Decision Making and Preferences for End-of-Life Care: Perspectives of Pakistani Patients Receiving Maintenance Dialysis. J Pain Symptom Manage. 2020 Aug;60(2):336-345. doi: 10.1016/j.jpainsymman.2020.03.009. Epub 2020 Mar 20.
- O'Hare AM, Kurella Tamura M, Lavallee DC, Vig EK, Taylor JS, Hall YN, Katz R, Curtis JR, Engelberg RA. Assessment of Self-reported Prognostic Expectations of People Undergoing Dialysis: United States Renal Data System Study of Treatment Preferences (USTATE). JAMA Intern Med. 2019 Oct 1;179(10):1325-1333. doi: 10.1001/jamainternmed.2019.2879. Erratum In: JAMA Intern Med. 2021 Jul 12;:null.
- Bernacki GM, Engelberg RA, Curtis JR, Kurella Tamura M, Brumback LC, Lavallee DC, Vig EK, O'Hare AM. Cardiopulmonary Resuscitation Preferences of People Receiving Dialysis. JAMA Netw Open. 2020 Aug 3;3(8):e2010398. doi: 10.1001/jamanetworkopen.2020.10398. Erratum In: JAMA Netw Open. 2021 Jun 1;4(6):e2115787.
- Saeed F, Sardar MA, Davison SN, Murad H, Duberstein PR, Quill TE. Patients' perspectives on dialysis decision-making and end-of-life care . Clin Nephrol. 2019 May;91(5):294-300. doi: 10.5414/CN109608.
- Scherer JS, Milazzo KC, Hebert PL, Engelberg RA, Lavallee DC, Vig EK, Kurella Tamura M, Roberts G, Curtis JR, O'Hare AM. Association Between Self-reported Importance of Religious or Spiritual Beliefs and End-of-Life Care Preferences Among People Receiving Dialysis. JAMA Netw Open. 2021 Aug 2;4(8):e2119355. doi: 10.1001/jamanetworkopen.2021.19355.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202303044RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
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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