Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063353) titled 'Effects of a Kikigaki Intervention for Advance Care Planning on Psychological Outcomes in Patients Undergoing Hemodialysis: A Pilot Study' on Oct. 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Gunma University

Condition: Condition - End-stage kidney disease: ESKD Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 12

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072515

Disclaimer: Curated by HT Syndication.