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Completed

NCT Number: NCT03426787

Helping Empower Liver and Kidney Patients

The overall purpose of this study is to develop and test a web-based decision aid (DA) to support patients with Hepatitis C and Chronic Kidney Disease during decisions about whether, when, and how to treat each illness. Patients will have the opportunity to learn about their hepatitis C and kidney disease, initiate thought about what matters most to them and choose a treatment plan for their liver and kidney disease that works best for them. Investigators will evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. There are three (3) primary aims of this project: (1) to develop the DA; (2) to pilot-test the DA to determine efficacy, usability and likelihood of using it in routine practice; (3) to explore stakeholders feedback on the usefulness of the DA and likelihood of implementing the tool.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Chronic Kidney Diseases Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Kidney Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Education RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

About this study

First, for Aim 1, Investigators along with direction from a diverse expert advisory group of nephrologists, hepatologists, and patient partners developed a decision aid based upon International Patient Decision Aids Standards guidelines, literature reviews, and expert advisory reviews. It includes plain language education, interactive learning modules personalized tailored information to help individuals use and consider information appropriate to their values and needs, and guidance on discussions with clinicians about treatment goals. Second, for Aim 2, Investigators will pilot-test the decision aid with 70 individuals in a pre-post within-subjects study design to evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. Lastly, for Aim 3, Investigators will conduct 30 semi-structured qualitative interviews with both clinicians and participants after the pilot evaluation of the decision aid to gather feedback about implementing the tool into clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must read and understand English AND
  • Must have Hepatitis C (any genotype) and Chronic Kidney Disease (any stage)

Exclusion criteria

  • Developed jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy also known as Decompensated cirrhosis; or
  • Currently has or had liver cancer (Hepatocellular carcinoma); or
  • Received a liver transplant

Treatment and study plan

Decision aid

Behavioral

Participants will have the option to view a web or paper-based version of the decision aid.

Primary outcomes

  1. Change in Knowledge

    Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.

    The percent correct out of eight questions created by the research team based on information that is considered vital to making treatment decisions, including understanding HCV and CKD, the health effects of both diseases, and understanding factors that differentiate treatment options. Scores range from 0 to 100. Higher scores demonstrate more knowledge.

  2. Change in Decisional Conflict Scale

    Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.

    The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice and feel they have enough support to make a choice. Scores range from 0 to 4. Higher scores indicate more confidence in their choice.

  3. Change in Decision Self-Efficacy Scale

    Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.

    The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions). Scores can range from 0 to 100. Higher scores indicate more confidence in participants ability to make a treatment choice.

Secondary outcomes

  1. System Usability Scale

    Time frame: Completed immediately after viewing the intervention

    A 10-item scale that evaluates the website's usability level. Scores can range from 0 to 100. An average score of 68 is considered a usable/adequate tool per measure guidelines. Higher scores represent better usability level for the tool.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Development and Validation of a Shared-decision Making Tool for Initiation of Treatment in Patients With Hepatitis C Infection and Advanced Chronic Kidney Disease

Acronym: Project HELP

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Sep 11, 2019

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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