Developing Tools for Dialysis Decision Support

August 21, 2025 updated by: Manjula Kurella Tamura, MD, MPH, VA Palo Alto Health Care System
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • U.S. Department of Veterans Affairs - Palo Alto Health Care System
      • Stanford, California, United States, 94305
        • Stanford Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Family/caregiver inclusion criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Web-based dialysis decision support tool
Behavioral: 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.
No Intervention: Control
Historical controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment choice
Time Frame: 1 month
Proportion of patients who are undecided about treatment choice.
1 month
Values treatment concordance
Time Frame: 1 month
Change in values treatment concordance.
1 month
Confidence in treatment decision
Time Frame: 1 month
Confidence in kidney failure treatment decision
1 month
Treatment choice
Time Frame: 1 month
Proportion of patients who choose medical management without dialysis
1 month
Decisional Conflict Scale (DCS)
Time Frame: 1 month
Change in the decisional conflict scale (DCS) score from baseline to follow-up. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Investigators

  • Principal Investigator: Manjula Tamura, MD, MPH, U.S. Department of Veterans Affairs - Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Actual)

April 10, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-54542
  • HX002763 (Other Grant/Funding Number: VA HSRD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Web-based dialysis decision support tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe