Developing Tools for Dialysis Decision Support

NCT ID: NCT06597279

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2026-09-30

Brief Summary

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The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.

Detailed Description

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This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a non-randomized controlled trial using historical control as a comparator. It involves comparing outcomes from a group of participants receiving the current intervention with outcomes from a previously treated group (historical control) that did not receive the intervention.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Web-based dialysis decision support tool

Group Type EXPERIMENTAL

Web-based dialysis decision support tool

Intervention Type BEHAVIORAL

The intervention in this study is the "Kidney Care Roadmap", a web-based dialysis decision support tool designed to assist patients with advanced chronic kidney disease and their caregivers.

Control

Historical controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Web-based dialysis decision support tool

The intervention in this study is the "Kidney Care Roadmap", a web-based dialysis decision support tool designed to assist patients with advanced chronic kidney disease and their caregivers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age \>=65
2. Estimated GFR \<25 ml/min/1.73m2
3. English speaking
4. Not a candidate for kidney transplant based on nephrologist assessment.


1. age \>=21
2. English speaking

Exclusion Criteria

a. Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Manjula Kurella Tamura, MD, MPH

Nephrologist and clinical investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manjula Tamura, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

U.S. Department of Veterans Affairs - Palo Alto Health Care System

Locations

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U.S. Department of Veterans Affairs - Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Stanford Health Care

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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HX002763

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-54542

Identifier Type: -

Identifier Source: org_study_id

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