Helping Empower Liver and Kidney Patients (Project HELP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03426787|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2018
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Chronic Kidney Diseases Patient Education||Behavioral: Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual 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|
|Actual Primary Completion Date :||October 15, 2018|
|Estimated Study Completion Date :||July 30, 2019|
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Missouri|
|Washington University in St. Louis School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Mary C Politi, PhD||Washington University School of Medicine|