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Helping Empower Liver and Kidney Patients (Project HELP)

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ClinicalTrials.gov Identifier: NCT03426787
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Mary C. Politi, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Chronic Kidney Diseases Patient Education Behavioral: Decision Aid Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: pre-post within subjects design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Decision Aid
A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.
Behavioral: Decision Aid
Participants will have the option to view a web or paper-based version of the decision aid.




Primary Outcome Measures :
  1. Usability [ Time Frame: Completed immediately after viewing the intervention ]
    A 10-item scale that evaluates the website's usability level

  2. Change in Knowledge [ Time Frame: At baseline and immediately after viewing the intervention, within 30 minutes. ]
    The percent correct out of eight questions that were created by the research team based on information that is considered vital to making treatment decisions, understanding what is HCV and CKD, the health effects of both diseases, and understanding facts that differentiate treatment option.

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426787


Contacts
Contact: Nerissa George, MPH 314-747-5657 n.george@wustl.edu
Contact: Nageen Mir, MPH 314-747-1968 nmir@wustl.edu

Locations
United States, Missouri
Washington University in St. Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nerissa George, MPH    314-747-5657    n.george@wustl.edu   
Principal Investigator: Mary C Politi, PhD         
Sub-Investigator: Tingting Li, MD         
Sub-Investigator: Kevin M Korenblat, MD         
Sponsors and Collaborators
Washington University School of Medicine
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Mary C Politi, PhD Washington University School of Medicine

Additional Information:
Responsible Party: Mary C. Politi, Associate Professor of Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03426787     History of Changes
Other Study ID Numbers: 201707154
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary C. Politi, Washington University School of Medicine:
Patient Centered
Pre-Post Design
Decision Support
Health Literacy

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Urologic Diseases
Renal Insufficiency