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OpenTrials
Active, Not Recruiting

NCT Number: NCT06597279

Developing Tools for Dialysis Decision Support

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Family/caregiver inclusion criteria:

  • age >=21
  • English speaking

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Treatment choice

    Time frame: 1 month

    Proportion of patients who are undecided about treatment choice.

  2. Values treatment concordance

    Time frame: 1 month

    Change in values treatment concordance.

  3. Confidence in treatment decision

    Time frame: 1 month

    Confidence in kidney failure treatment decision

  4. Treatment choice

    Time frame: 1 month

    Proportion of patients who choose medical management without dialysis

  5. 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].

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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