Developing Tools for Dialysis Decision Support

NCT06597279 | Active Not Recruiting

• 2 other identifiers: IRB-54542HX002763
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (5)

• Treatment choice

  Proportion of patients who are undecided about treatment choice.

  1 month

• Values treatment concordance

  Change in values treatment concordance.

  1 month

• Confidence in treatment decision

  Confidence in kidney failure treatment decision

  1 month

• Treatment choice

  Proportion of patients who choose medical management without dialysis

  1 month

• Decisional Conflict Scale (DCS)

  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

Study Arms (2)

Intervention

EXPERIMENTAL

Web-based dialysis decision support tool

Behavioral: Web-based dialysis decision support tool

Control

NO INTERVENTION

Historical controls

Interventions

Web-based dialysis decision support tool 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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>=65
• Estimated GFR \<25 ml/min/1.73m2
• English speaking
• Not a candidate for kidney transplant based on nephrologist assessment.
• age \>=21
• English speaking

You may not qualify if:

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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (2)

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

Palo Alto, California, 94304, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manjula Tamura, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist and clinical investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 21, 2024
• Primary Completion: April 10, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)