Helping Empower Liver and Kidney Patients

NCT03426787 | Completed Results DMC

• 1 other identifier: 201707154
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Chronic Kidney Diseases; Patient Education

Keywords

Patient Centered; Pre-Post Design; Decision Support; Health Literacy

Outcome Measures

Primary Outcomes (3)

• Change in Knowledge

  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.

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

• Change in Decisional Conflict Scale

  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.

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

• Change in Decision Self-Efficacy Scale

  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.

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

Secondary Outcomes (1)

• System Usability Scale

  Completed immediately after viewing the intervention

Study Arms (1)

Decision Aid

EXPERIMENTAL

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

Interventions

Decision Aid BEHAVIORAL

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

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• George N, Liapakis A, Korenblat KM, Li T, Roth D, Yee J, Fowler KJ, Howard L, Liu J, Politi MC. A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment. Kidney Med. 2019 Jul 11;1(4):200-206. doi: 10.1016/j.xkme.2019.06.003. eCollection 2019 Jul-Aug.

  PMID: 32734200 DERIVED

Related Links

• Decisional Conflict Scale Measure
• Decision Self-Efficacy Scale Measure
• Usability Scale Measure

MeSH Terms

Conditions

Hepatitis C; Renal Insufficiency, Chronic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; 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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

Given the small sample and pilot study design, the reported observations can be interpreted as preliminary results. This project was also a single site study. Results might not be generalizable across other regions.

Results Point of Contact

• Title: Dr. Mary C Politi
• Organization: Washington University in St. Louis School of Medicine

mpoliti@wustl.edu

3147471967

Study Officials

• Mary C Politi, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: pre-post within subjects design

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 8, 2018
• Study Start: September 26, 2017
• Primary Completion: October 15, 2018
• Study Completion: July 30, 2019
• Last Updated: September 11, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-09

Locations

US (1)