- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046261
Exploring the Impact of " ACP Board Game for Life" on Death Preparation and Anxiety in Patients With Stage 4 and 5 Chronic Kidney Diseases: A Pilot Study
September 21, 2023 updated by: National Cheng-Kung University Hospital
This study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was to explore the impacts of participating in "ACP board game for life" on death preparation, death anxiety, end-of-life care preferences, and intervention perception in stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.
A nonrandomized two-arm pretest and posttest quasi-experimental design was used.
Patients in the control group received routine care while patients in the experimental group received routine care and ACP board game for life.
The ACP board game, death preparation subscale, Chinese Likert death anxiety scale, self-created questionnaires and brief interview were used for data collection.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan, 704
- National Cheng Kung University Hospital
-
-
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
No
Description
Inclusion Criteria:
- Stage 4-5 chronic kidney disease patients
- Chinese nationality
- Over 20 years old
- Consciousness clear, can communicate and express their opinions in Mandarin and Taiwanese
Exclusion Criteria:
- Patients express that talking about death makes them feel scared or cause anxiety
- The doctor assesses that the patient's condition is in the stage of septic shock, hemodynamic instability, asthma, pulmonary edema, hypoxemia or acute myocardial infarction
- Patients with contact or airborne precautions
- Patients without legal capacity
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
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: General routine care and ACP board game for life
|
The research subjects will be assigned to the experimental group or the control group according to their wishes.
Those who are willing to participate the ACP board game will be assigned to the experimental group.
The intervention time for each board game is around 2 hours.
There are 60 cards in this ACP board game; the focus of the game is to know the participants' thoughts on the card options.
Questionnaires need to be filled in before and after intervention.
|
|
No Intervention: General routine care
"General routine care" means that when a CKD stage 4-5 patient is in critical condition or at the end of life, the renal medical team will explain the content of DNR to the patient's family (without cardiopulmonary resuscitation: including endotracheal tube intubation, extracorporeal cardiac compression, Emergency treatment items such as cardiac electric shock, emergency drug injection, and artificial cardiac pacemaker adjustment), the concept of palliative care (supportive care for end-of-life patients to relieve physical discomfort symptoms to reduce physical, mental and spiritual pain) or ACP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Death Preparation
Time Frame: 2hours
|
The death preparation subscale total of 8 items measure death preparation.The range of total scores of the subscale is 8-40.
It shows that the higher scores, the better death preparedness.
|
2hours
|
|
Death Anxiety
Time Frame: 2hours
|
The Chinese Likert death anxiety scale was used, with a total of 15 items, using a Likert scale of 1 to 5 (1 means completely disagree, 2 means disagree, 3 means fair, 4 means agree, and 5 means completely agree) ), the total scores of the scale ranges from 15 to 75.
The higher total scores, the higher degree of death anxiety.
|
2hours
|
|
End-of-Life Care Preferences
Time Frame: 2hours
|
A self-made questionnaire on end-of-life care preferences for patients with stage 4-5 CKD was used.
There were 2 items in the scale.
The item type was multiple choice, the scoring method is based on the number of times and percentages chosen by the participants.
|
2hours
|
|
Intervention Perception
Time Frame: 2hours
|
A self-made questionnaire on the feelings of CKD stage 4-5 patients after participating in the " ACP board game for life " was used.
There are 4 items in the scale, using a Likert scoring method of 1 to 5 points (1 point means completely disagree, 2 points means disagree, 3 points means neither agree nor disagree, 4 points means agree, 5 points means strongly agree), the scoring method is based on the participant's options for Mean±SD, frequency and percentage statistics.
|
2hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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- Hong YA, Chung S, Park WY, Bae EJ, Yang JW, Shin DH, Kim SW, Shin SJ; Committee on Ethical Issues of the Korean Society of Nephrology. Nephrologists' Perspectives on Decision Making About Life-Sustaining Treatment and Palliative Care at End of Life: A Questionnaire Survey in Korea. J Palliat Med. 2021 Apr;24(4):527-535. doi: 10.1089/jpm.2020.0248. Epub 2020 Sep 30.
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- Khodarahimi S, Veiskarami HA, Mazraeh N, Sheikhi S, Rahimian Bougar M. Mental Health, Social Support, and Death Anxiety in Patients With Chronic Kidney Failure. J Nerv Ment Dis. 2021 Nov 1;209(11):809-813. doi: 10.1097/NMD.0000000000001386.
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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)
January 1, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 14, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Anxiety Disorders
- Death
- Kidney Failure, Chronic
- Renal Insufficiency
Other Study ID Numbers
- B-ER-110-472
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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