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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

Primary Purpose

Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ACP board game for life
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Death Preparation, Death Anxiety, Advance Care Planning, Board Game

Eligibility Criteria

21 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

General routine care and ACP board game for life

General routine care

Arm Description

"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.

Outcomes

Primary Outcome Measures

Death Preparation
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.
Death Anxiety
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.
End-of-Life Care Preferences
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.
Intervention Perception
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 21, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06046261
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Insufficiency, End of Life Care, Advance Care Planning, Death Anxiety
Keywords
Chronic Kidney Disease, Death Preparation, Death Anxiety, Advance Care Planning, Board Game

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General routine care and ACP board game for life
Arm Type
Experimental
Arm Title
General routine care
Arm Type
No Intervention
Arm Description
"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.
Intervention Type
Other
Intervention Name(s)
ACP board game for life
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death Preparation
Description
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.
Time Frame
2hours
Title
Death Anxiety
Description
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.
Time Frame
2hours
Title
End-of-Life Care Preferences
Description
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.
Time Frame
2hours
Title
Intervention Perception
Description
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.
Time Frame
2hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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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

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