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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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ClinicalTrials.gov Identifier: NCT06046261
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Renal Failure Chronic Renal Insufficiency End of Life Care Advance Care Planning Death Anxiety Other: ACP board game for life Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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
Actual Study Start Date : January 1, 2022
Actual Primary Completion Date : February 28, 2023
Actual Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: General routine care and ACP board game for life Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046261


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
More Information
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Publications:

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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT06046261    
Other Study ID Numbers: B-ER-110-472
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cheng-Kung University Hospital:
Chronic Kidney Disease
Death Preparation
Death Anxiety
Advance Care Planning
Board Game
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Death
Anxiety Disorders
Mental Disorders
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Chronic Disease
Disease Attributes
Pathologic Processes