Chronic Kidney DiseaseNCT06046261

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

A study testing ACP board game for life in people with Chronic Kidney Disease and Chronic Renal Failure, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 78 years
Conditions the study is for: Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Insufficiency
What is being tested?: ACP board game for life
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteTaiwan
Study dates: 1 Jan 2022to 28 Feb 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Cheng Kung University Hospital
Tainan, 704

Other trials in Taiwan

About this study

Read the 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.

Conditions: Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Insufficiency, End of Life Care, Advance Care Planning, Death Anxiety
Being tested: ACP board game for life
Keywords: Chronic Kidney Disease, Death Preparation, Death Anxiety, Advance Care Planning, Board Game
Medical subject headings: Renal Insufficiency, Chronic, Kidney Failure, Chronic, Necrophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACP board game for lifeOther
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.

Study groups in NCT06046261
Study group	Role	What they receive
General routine care and ACP board game for life	Experimental	Not described Receives: Other: ACP board game for life
General routine care	No intervention	"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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2hours
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.
Measured: 2hours
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.
Measured: 2hours
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.
Measured: 2hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202228 Feb 2023

First posted21 Sep 2023
Study start1 Jan 2022
Primary completion28 Feb 2023
Study completion28 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (63)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06046261
Sponsor's protocol ID: B-ER-110-472
Status last verified: Sep 2023
First submitted: 13 Sep 2023
Last updated: 25 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Abdel-Khalek AM, El Nayal MA. Death anxiety in Lebanese college students in 1998 and 2015. Death Stud. 2019;43(9):542-546. doi: 10.1080/07481187.2018.1500006. Epub 2018 Sep 5.
PubMed 30183514
An E, Lo C, Hales S, Zimmermann C, Rodin G. Demoralization and death anxiety in advanced cancer. Psychooncology. 2018 Nov;27(11):2566-2572. doi: 10.1002/pon.4843. Epub 2018 Aug 20.
PubMed 30053317
Ang YG, Heng BH, Saxena N, Liew STA, Chong PN. Annual all-cause mortality rate for patients with diabetic kidney disease in Singapore. J Clin Transl Endocrinol. 2016 Jan 27;4:1-6. doi: 10.1016/j.jcte.2016.01.002. eCollection 2016 Jun.
PubMed 29159125
Axelsson L, Alvariza A, Lindberg J, Ohlen J, Hakanson C, Reimertz H, Furst CJ, Arestedt K. Unmet Palliative Care Needs Among Patients With End-Stage Kidney Disease: A National Registry Study About the Last Week of Life. J Pain Symptom Manage. 2018 Feb;55(2):236-244. doi: 10.1016/j.jpainsymman.2017.09.015. Epub 2017 Sep 21.
PubMed 28941964
Bekker YAC, Suntjens AF, Engels Y, Schers H, Westert GP, Groenewoud AS. Advance care planning in primary care: a retrospective medical record study among patients with different illness trajectories. BMC Palliat Care. 2022 Feb 14;21(1):21. doi: 10.1186/s12904-022-00907-6.
PubMed 35152892
Caserta M, Utz R, Lund D, Supiano K, Donaldson G. Cancer Caregivers' Preparedness for Loss and Bereavement Outcomes: Do Preloss Caregiver Attributes Matter? Omega (Westport). 2019 Dec;80(2):224-244. doi: 10.1177/0030222817729610. Epub 2017 Sep 8.
PubMed 28886674
Chan HL, Li IF, Tseng LC, Hsiung Y. Exploring Behavioral Readiness and Program Strategies to Engage Older Community Residents in Advance Care Planning: A Pilot Mixed-Method Study in Taiwan. Int J Environ Res Public Health. 2020 Jun 16;17(12):4285. doi: 10.3390/ijerph17124285.
PubMed 32560049
Chan TH, Chan FM, Tin AF, Chow AY, Chan CL. Death preparation and anxiety: a survey in Hong Kong. Omega (Westport). 2006-2007;54(1):67-78. doi: 10.2190/6478-6572-v704-1545.
PubMed 17844773
Cross SH, Lakin JR, Mendu M, Mandel EI, Warraich HJ. Trends in Place of Death for Individuals With Deaths Attributed to Advanced Chronic or End-Stage Kidney Disease in the United States. J Pain Symptom Manage. 2021 Jan;61(1):112-120.e1. doi: 10.1016/j.jpainsymman.2020.08.001. Epub 2020 Aug 10.
PubMed 32791183
Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):195-204. doi: 10.2215/CJN.05960809. Epub 2010 Jan 14.
PubMed 20089488
Delanaye P, Jager KJ, Bokenkamp A, Christensson A, Dubourg L, Eriksen BO, Gaillard F, Gambaro G, van der Giet M, Glassock RJ, Indridason OS, van Londen M, Mariat C, Melsom T, Moranne O, Nordin G, Palsson R, Pottel H, Rule AD, Schaeffner E, Taal MW, White C, Grubb A, van den Brand JAJG. CKD: A Call for an Age-Adapted Definition. J Am Soc Nephrol. 2019 Oct;30(10):1785-1805. doi: 10.1681/ASN.2019030238. Epub 2019 Sep 10.
PubMed 31506289
Deodhar J, Nagaraju SP, Kirpalani AL, Nayak AM. Shared Decision-Making, Advance Care Planning for Chronic Kidney Disease Patients. Indian J Palliat Care. 2021 May;27(Suppl 1):S33-S36. doi: 10.4103/ijpc.ijpc_71_21. Epub 2021 May 30.
PubMed 34188376
Desta BZ, Dadi AF, Derseh BT. Mortality in hemodialysis patients in Ethiopia: a retrospective follow-up study in three centers. BMC Nephrol. 2023 Jan 4;24(1):3. doi: 10.1186/s12882-022-03053-6.
PubMed 36600194
Douglas CA. Palliative care for patients with advance chronic kidney disease. J R Coll Physicians Edinb. 2014;44(3):224-31. doi: 10.4997/JRCPE.2014.309.
PubMed 25318401
Durepos P, Sussman T, Ploeg J, Akhtar-Danesh N, Punia H, Kaasalainen S. What Does Death Preparedness Mean for Family Caregivers of Persons With Dementia? Am J Hosp Palliat Care. 2019 May;36(5):436-446. doi: 10.1177/1049909118814240. Epub 2018 Dec 5.
PubMed 30518228

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06046261
Acronym / sponsor ID: B-ER-110-472
Conditions: 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
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: National Cheng-Kung University HospitalUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 28 Feb 2023 (actual)
First posted: 21 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
General routine care and ACP board game for life	Experimental	Other: ACP board game for life
General routine care	No intervention	–"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.

Who may qualify

Ages: 21 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACP board game for lifeThe 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.	Other	General routine care and ACP board game for life

Primary outcome

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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
Background: PubMed 30183514Abdel-Khalek AM, El Nayal MA. Death anxiety in Lebanese college students in 1998 and 2015. Death Stud. 2019;43(9):542-546. doi: 10.1080/07481187.2018.1500006. Epub 2018 Sep 5.
Background: PubMed 30053317An E, Lo C, Hales S, Zimmermann C, Rodin G. Demoralization and death anxiety in advanced cancer. Psychooncology. 2018 Nov;27(11):2566-2572. doi: 10.1002/pon.4843. Epub 2018 Aug 20.
Background: PubMed 29159125Ang YG, Heng BH, Saxena N, Liew STA, Chong PN. Annual all-cause mortality rate for patients with diabetic kidney disease in Singapore. J Clin Transl Endocrinol. 2016 Jan 27;4:1-6. doi: 10.1016/j.jcte.2016.01.002. eCollection 2016 Jun.
Background: PubMed 28941964Axelsson L, Alvariza A, Lindberg J, Ohlen J, Hakanson C, Reimertz H, Furst CJ, Arestedt K. Unmet Palliative Care Needs Among Patients With End-Stage Kidney Disease: A National Registry Study About the Last Week of Life. J Pain Symptom Manage. 2018 Feb;55(2):236-244. doi: 10.1016/j.jpainsymman.2017.09.015. Epub 2017 Sep 21.
Background: PubMed 35152892Bekker YAC, Suntjens AF, Engels Y, Schers H, Westert GP, Groenewoud AS. Advance care planning in primary care: a retrospective medical record study among patients with different illness trajectories. BMC Palliat Care. 2022 Feb 14;21(1):21. doi: 10.1186/s12904-022-00907-6.
Background: PubMed 28886674Caserta M, Utz R, Lund D, Supiano K, Donaldson G. Cancer Caregivers' Preparedness for Loss and Bereavement Outcomes: Do Preloss Caregiver Attributes Matter? Omega (Westport). 2019 Dec;80(2):224-244. doi: 10.1177/0030222817729610. Epub 2017 Sep 8.
Background: PubMed 32560049Chan HL, Li IF, Tseng LC, Hsiung Y. Exploring Behavioral Readiness and Program Strategies to Engage Older Community Residents in Advance Care Planning: A Pilot Mixed-Method Study in Taiwan. Int J Environ Res Public Health. 2020 Jun 16;17(12):4285. doi: 10.3390/ijerph17124285.
Background: PubMed 17844773Chan TH, Chan FM, Tin AF, Chow AY, Chan CL. Death preparation and anxiety: a survey in Hong Kong. Omega (Westport). 2006-2007;54(1):67-78. doi: 10.2190/6478-6572-v704-1545.
Background: PubMed 32791183Cross SH, Lakin JR, Mendu M, Mandel EI, Warraich HJ. Trends in Place of Death for Individuals With Deaths Attributed to Advanced Chronic or End-Stage Kidney Disease in the United States. J Pain Symptom Manage. 2021 Jan;61(1):112-120.e1. doi: 10.1016/j.jpainsymman.2020.08.001. Epub 2020 Aug 10.
Background: PubMed 20089488Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):195-204. doi: 10.2215/CJN.05960809. Epub 2010 Jan 14.
Background: PubMed 31506289Delanaye P, Jager KJ, Bokenkamp A, Christensson A, Dubourg L, Eriksen BO, Gaillard F, Gambaro G, van der Giet M, Glassock RJ, Indridason OS, van Londen M, Mariat C, Melsom T, Moranne O, Nordin G, Palsson R, Pottel H, Rule AD, Schaeffner E, Taal MW, White C, Grubb A, van den Brand JAJG. CKD: A Call for an Age-Adapted Definition. J Am Soc Nephrol. 2019 Oct;30(10):1785-1805. doi: 10.1681/ASN.2019030238. Epub 2019 Sep 10.
Background: PubMed 34188376Deodhar J, Nagaraju SP, Kirpalani AL, Nayak AM. Shared Decision-Making, Advance Care Planning for Chronic Kidney Disease Patients. Indian J Palliat Care. 2021 May;27(Suppl 1):S33-S36. doi: 10.4103/ijpc.ijpc_71_21. Epub 2021 May 30.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACP board game for life in people with Chronic Kidney Disease and Chronic Renal Failure, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death Preparation (time frame: 2hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046261, which also lists 63 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.