UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063353 |
|---|---|
| Receipt number | R000072515 |
| Scientific Title | Effects of a Kikigaki Intervention for Advance Care Planning on Psychological Outcomes in Patients Undergoing Hemodialysis: A Pilot Study |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/20 16:24:46 |
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Basic information
Public title
Effects of a Kikigaki Intervention for Advance Care Planning on Psychological Outcomes in Patients Undergoing Hemodialysis: A Pilot Study
Acronym
Kikigaki-ACP-HD Pilot Study
Scientific Title
Effects of a Kikigaki Intervention for Advance Care Planning on Psychological Outcomes in Patients Undergoing Hemodialysis: A Pilot Study
Scientific Title:Acronym
Kikigaki-ACP-HD Pilot Study
Region
| Japan |
Condition
Condition
End-stage kidney disease: ESKD
Classification by specialty
| Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of a Kikigaki intervention related to advance care planning (ACP) on decisional conflict, uncertainty, and self-understanding among patients undergoing hemodialysis, and to obtain preliminary evidence regarding the potential usefulness of Kikigaki as an approach to supporting ACP in this population.
This study will be conducted as a pilot study, and its findings will be used to refine the research design for a subsequent full-scale study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Decisional conflict will be assessed using the 16-item Decisional Conflict Scale (DCS).
The DCS total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
The pre-intervention assessment will be completed between questionnaire distribution and the next scheduled hemodialysis session. The post-intervention assessment will be completed within two weeks after participants review the finalized Kikigaki booklet. Changes in DCS scores between the two time points will be evaluated exploratorily.
Key secondary outcomes
The secondary outcome will be assessed using the "Watashirashisa no Jikaku Sheet" (Self-Awareness of Personal Identity Sheet), a 10-item questionnaire developed by the study investigators.
The pre-intervention assessment will be conducted between questionnaire distribution and the next scheduled hemodialysis session. The post-intervention assessment will be conducted within two weeks after participants review the finalized Kikigaki booklet. Changes in questionnaire scores between the two time points will be evaluated exploratorily.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Patients undergoing hemodialysis will receive a Kikigaki intervention related to advance care planning (ACP).
At each participating facility, the principal investigator or a co-investigator will use a Kikigaki booklet and an interview guide to standardize the intervention. Participants' narratives will be recorded in notes and transcribed into the booklet while preserving their own words as much as possible.
The intervention will be conducted during or before or after hemodialysis sessions. The interview is expected to take approximately one hour but may be divided into multiple shorter sessions depending on the participant's condition.
Participants will review the prepared booklet, which will be revised as needed before the finalized version is provided to them.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who understand the content, significance, and purpose of the study and provide informed consent to participate.
2)Patients who agree to the researcher taking notes during the Kikigaki intervention.
3)Patients who agree to copies of their completed Kikigaki booklet being shared among the researchers.
4)Patients receiving maintenance hemodialysis on an outpatient basis.
5)Patients who are able to communicate in Japanese.
6)Patients without visual impairment.
7)Patients who have obtained approval from their attending physician to participate in the study.
Key exclusion criteria
1)Patients who require special accommodations for communication due to hearing impairment, aphasia, or other conditions.
2)Patients who are deemed ineligible to participate in the study by their attending physician based on clinical examinations or assessments, including those with depressive symptoms or progression of dementia.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Oka |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7111
michiyooka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sasaki |
Organization
Iwate Prefectural Chubu Hospital
Division name
Dialysis Unit
Zip code
024-8507
Address
17-10 Murasakino, Kitakami, Iwate, Japan
TEL
0197-71-1511
Homepage URL
h251a007@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Board for Human Subjects
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.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
岩手県立中部病院（岩手県）、医療法人社団偕翔会 静岡共立クリニック（静岡県）、医療法人恵泉会 せせらぎ病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 10 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2026 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072515
