Trial Outcomes & Findings for Helping Empower Liver and Kidney Patients (NCT NCT03426787)
NCT ID: NCT03426787
Last Updated: 2019-09-11
Results Overview
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.
COMPLETED
NA
70 participants
At baseline and immediately after viewing the intervention, within 30 minutes.
2019-09-11
Participant Flow
Participant milestones
| Measure |
Project HELP 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. Participants will have the option to view a web or paper-based version of the decision aid.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Project HELP 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. Participants will have the option to view a web or paper-based version of the decision aid.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Unrelated to intervention death
|
1
|
Baseline Characteristics
Helping Empower Liver and Kidney Patients
Baseline characteristics by cohort
| Measure |
Decision Support Tool
n=56 Participants
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.
Decision Aid: Participants will have the option to view a web or paper-based version of the decision aid.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
|
Age, Continuous
|
60.95 years
STANDARD_DEVIATION 6.58 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Education
Less than or some high school
|
22 Participants
n=99 Participants
|
|
Education
High school diploma or GED
|
13 Participants
n=99 Participants
|
|
Education
Technical Training or Certification
|
5 Participants
n=99 Participants
|
|
Education
Some college
|
11 Participants
n=99 Participants
|
|
Education
College degree or highe
|
5 Participants
n=99 Participants
|
|
Type of Insurance Coverage
Private
|
2 Participants
n=99 Participants
|
|
Type of Insurance Coverage
Governmental (Medicaid, Medicare, & VA/TriCare
|
52 Participants
n=99 Participants
|
|
Type of Insurance Coverage
Uninsured
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At baseline and immediately after viewing the intervention, within 30 minutes.Population: Participants completed both pre and post-test survey questions for the knowledge questions.
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.
Outcome measures
| Measure |
Knowledge Pre-Test Scores
n=56 Participants
Participants knowledge scores at the baseline level.
|
Knowledge Post Test Scores
n=54 Participants
Participants knowledge scores after using intervention
|
|---|---|---|
|
Change in Knowledge
|
53.54 percentage of correct responses
Standard Deviation 21.31
|
65.74 percentage of correct responses
Standard Deviation 22.80
|
PRIMARY outcome
Timeframe: At baseline and immediately after viewing the intervention, within 30 minutes.Population: Participants completed both pre and post-test survey questions for the 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.
Outcome measures
| Measure |
Knowledge Pre-Test Scores
n=55 Participants
Participants knowledge scores at the baseline level.
|
Knowledge Post Test Scores
n=54 Participants
Participants knowledge scores after using intervention
|
|---|---|---|
|
Change in Decisional Conflict Scale
|
2.64 score on a scale
Standard Deviation 1.38
|
3.13 score on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: At baseline and immediately after viewing the intervention, within 30 minutes.Population: Participants completed both pre and post-test survey questions for the 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.
Outcome measures
| Measure |
Knowledge Pre-Test Scores
n=56 Participants
Participants knowledge scores at the baseline level.
|
Knowledge Post Test Scores
n=54 Participants
Participants knowledge scores after using intervention
|
|---|---|---|
|
Change in Decision Self-Efficacy Scale
|
84.42 score on a scale
Standard Deviation 17.07
|
86.62 score on a scale
Standard Deviation 18.88
|
SECONDARY outcome
Timeframe: Completed immediately after viewing the interventionPopulation: Participants completed the system usability scale in our post-test questionnaire.
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.
Outcome measures
| Measure |
Knowledge Pre-Test Scores
n=54 Participants
Participants knowledge scores at the baseline level.
|
Knowledge Post Test Scores
Participants knowledge scores after using intervention
|
|---|---|---|
|
System Usability Scale
|
69.86 score on a scale
Standard Deviation 20.43
|
—
|
Adverse Events
Project HELP Decision Aid
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mary C Politi
Washington University in St. Louis School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place