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Shared Decision-Making for Families in Critical Dialysis Initiation

NCT07150182 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

The Integrated Shared Decision-making Program

The Integrated Shared Decision-making Program

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150182 on ClinicalTrials.gov