Not Yet RecruitingNot Applicable

Shared Decision-Making for Families in Critical Dialysis Initiation

100 participantsStarted 2025-10-01

Plain-language summary

Background:Acute kidney injury (AKI) is a frequent and serious complication in critically ill patients, often necessitating difficult decisions about starting hemodialysis. While shared decision-making (SDM) is known to improve communication, the effectiveness of structured SDM programs specifically designed for family members in this critical context is not well-established. Aims: The primary purpose of this study is to evaluate the effectiveness of a structured shared decision-making (SDM) program for family members of patients requiring critical hemodialysis initiation. We will assess the program's impact on the quality of the decision-making process (e.g., decision conflict, regret) and the psychological well-being (e.g., anxiety, depression) of the family members. Methods: This study is a parallel-group, randomized controlled trial. Eligible participants (family members of patients with AKI initiating hemodialysis) will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured SDM support program, while the control group will receive standard care. Primary outcomes, including decision conflict, decision regret, anxiety, and depression, will be measured at baseline and follow-up. Data will be analyzed using the generalized estimating equation (GEE) model to compare the effectiveness between the two groups.

Who can participate

Age range

20 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 20 years.
. Mentally alert and able to communicate in Mandarin or Taiwanese.
. Key person for the patient's admission (primary contact between patient, family, and medical team).
. Willing to participate in the clinical trial.

Exclusion criteria

. Age \< 20 years.
. End-stage kidney disease already receiving renal replacement therapy (including hemodialysis, peritoneal dialysis, or kidney transplantation). (B) Family members:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

decision conflict

Timeframe: Follow-up assessments will be conducted four times: at baseline, one week, two weeks, and one month after the intervention.

Trial details

NCT IDNCT07150182

SponsorTaipei Medical University WanFang Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Chung-te Liu

+886970746583 96320@w.tmu.edu.tw

View on ClinicalTrials.gov More Acute Kidney Injury trials