UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060302 |
|---|---|
| Receipt number | R000066960 |
| Scientific Title | Testing the effectiveness of gaming-based intervention for advance care planning (ACP) in the community elderly |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/08 16:24:02 |
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Basic information
Public title
Testing the effectiveness of gaming-based intervention for advance care planning (ACP) in the community elderly
Acronym
Testing the effectiveness of gaming-based intervention for advance care planning (ACP) in the community elderly
Scientific Title
Testing the effectiveness of gaming-based intervention for advance care planning (ACP) in the community elderly
Scientific Title:Acronym
Testing the effectiveness of gaming-based intervention for advance care planning (ACP) in the community elderly
Region
| Japan |
Condition
Condition
Local Elderly
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the aging population has reached unprecedented levels, with individuals aged 65 and over accounting for approximately 29% of the total population as of October 2023. To maintain and enhance the quality of life (QOL) for older adults, attention must be paid not only to physical and cognitive health but also to psychological and social well-being. Among these factors, self-efficacy and readiness are critical psychological components that support older adults in adapting to life changes and maintaining autonomy.
Self-efficacy refers to the belief in one's own ability to take appropriate action, and it is known to correlate with proactive health behaviors and social engagement. Readiness is defined as the willingness and ability to adapt to new environments and changes, and it also plays a key role in decision-making regarding future medical and care needs.
Advance Care Planning (ACP), which encourages individuals to consider and communicate their values and preferences for future medical care, requires both self-efficacy and readiness. However, many older adults struggle to initiate ACP discussions despite recognizing their importance.
Recent studies have shown that digital games can contribute to improved cognitive function and psychological well-being among older adults. Game-based experiences involving challenges and role-play may enhance self-efficacy, reduce resistance to ACP, and foster readiness to engage in future planning.
This study aims to examine the effects of gaming experiences on self-efficacy, readiness, and attitudes toward ACP among older adults aged 65 and above. By conducting pre- and post-gameplay questionnaires, we will assess psychological changes and explore the potential of gaming as a novel intervention to promote ACP in an aging society.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in self-efficacy (ACPES 5-point scale)
Key secondary outcomes
Readiness (ACPES 5-point scale)
Whether ACP is implemented
Whether advance directives are prepared
Whether an agent is selected
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
This is a non-invasive study that does not involve physical invasion or drug intervention. Therefore, the medical and physical risks are considered to be extremely low
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Be 65 years old or older
(2) Show interest in ACP and be able to understand the explanation about ACP
(3) Be able to understand the explanation of the card game rules
(4) Be able to participate in the card game and the questionnaire survey
(5) Be able to give his/her consent after receiving an explanation of this study
Key exclusion criteria
1) Those who have been diagnosed with dementia or severe cognitive impairment
2) Those who have a history of mental illness and are deemed to have difficulty participating in this study
3) Those who have significant visual or hearing impairment and have difficulty playing games or answering questionnaires
4) Those whose health condition is expected to deteriorate rapidly during the study period
5) Others whom the principal investigator deems unsuitable
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Terasawa |
Organization
Fujita Medical University, Graduate School of Medicine, Department of Medicine, Clinical Medicine Field
Division name
Acute Comprehensive Medicine and General Internal Medicine
Zip code
470-1192
Address
1-98 Tarakukubo, Kutsugake-cho, Toyoake-shi, Aichi, Japan
TEL
0562-93-2000
81024033@fujita-h.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Fushimi |
Organization
Fujita Medical University, Graduate School of Medicine, Department of Medicine, Clinical Medicine Fi
Division name
Acute Comprehensive Medicine and General Internal Medicine
Zip code
6638231
Address
1-98 Tarakukubo, Kutsugake-cho, Toyoake-shi, Aichi, Japan
TEL
09016767184
Homepage URL
ocean_blue6332@yahoo.co.jp
Sponsor or person
Institute
FUJITA HEALTH UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Medical University, Graduate School of Medicine, Department of Medicine, Clinical Medicine Field
Address
Fujita Medical University, Graduate School of Medicine, Department of Medicine, Clinical Medicine Fi
Tel
09016767184
ocean_blue6332@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066960
