Hepatitis CProject HELPNCT03426787

Helping Empower Liver and Kidney Patients

A study testing Decision Aid in people with Hepatitis C and Chronic Kidney Diseases, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic Kidney Diseases, Patient Education
What is being tested?: Decision Aid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2017to 30 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Hepatitis C, Chronic Kidney Diseases, Patient Education
Being tested: Decision Aid
Keywords: Patient Centered, Pre-Post Design, Decision Support, Health Literacy
Medical subject headings: Hepatitis C, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03426787
Study group	Role	What they receive
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. Receives: Behavioral: Decision Aid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

System Usability Scale
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.
Measured: Completed immediately after viewing the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201730 Jul 2019

First posted8 Feb 2018
Study start26 Sep 2017
Primary completion15 Oct 2018
Study completion30 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: pre-post within subjects design
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03426787
Sponsor's protocol ID: 201707154
Acronym: Project HELP
Status last verified: Sep 2019
First submitted: 21 Jan 2018
Last updated: 11 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32734200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03426787
Acronym / sponsor ID: Project HELP / 201707154
Conditions: Hepatitis C, Chronic Kidney Diseases, Patient Education
Keywords: Patient Centered, Pre-Post Design, Decision Support, Health Literacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 26 Sep 2017 (actual)
Primary completion: 15 Oct 2018 (actual)
Study completion: 30 Jul 2019 (actual)
First posted: 8 Feb 2018 (actual)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: pre-post within subjects design

Arm	Type	Receives
Decision Aid	Experimental	Behavioral: Decision AidA decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Decision AidParticipants will have the option to view a web or paper-based version of the decision aid.	Behavioural	Decision Aid

Primary outcome

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.

1 secondary outcome

System Usability Scale
Time frame: Completed immediately after viewing the intervention

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Project HELP Decision Aid	70	56

Primary outcome: Change in Knowledge

Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.. Mean (Standard Deviation). Unit: percentage of correct responses

Measure	Knowledge Pre-Test Scores n = 56	Knowledge Post Test Scores n = 54
Value	53.54 (21.31)	65.74 (22.80)

Knowledge Pre-Test Scores vs Knowledge Post Test Scores: Mean Difference (Final Values): -12.30216 (95% CI -18.95 to -5.6531), p <0.001, t-test, 2 sided

Population analysed: Participants completed both pre and post-test survey questions for the knowledge questions.

Primary outcome: Change in Decisional Conflict Scale

Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.. Mean (Standard Deviation). Unit: score on a scale

Measure	Decisional Conflict Pre-Test Scores n = 55	Decisional Conflict Post Test Scores n = 54
Value	2.64 (1.38)	3.13 (1.40)

Decisional Conflict Pre-Test Scores vs Decisional Conflict Post Test Scores: Mean Difference (Final Values): -0.4717 (95% CI -0.9355 to -0.00793), p = 0.0463, t-test, 2 sided

Population analysed: Participants completed both pre and post-test survey questions for the decisional conflict scale.

Primary outcome: Change in Decision Self-Efficacy Scale

Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.. Mean (Standard Deviation). Unit: score on a scale

Measure	Decision Self Efficacy Pre-Test Scores n = 56	Decision Self Efficacy Post Test Scores n = 54
Value	84.42 (17.07)	86.62 (18.88)

Decision Self Efficacy Pre-Test Scores vs Decision Self Efficacy Post Test Scores: Median Difference (Final Values): -1.9360 (95% CI -7.4086 to 3.5365), p >0.05, t-test, 2 sided

Population analysed: Participants completed both pre and post-test survey questions for the decision self-efficacy scale.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Project HELP Decision Aid	0 of 70 (0%)	0 of 70 (0%)	1 of 70

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32734200George 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.
Decisional Conflict Scale MeasureLink provided by the sponsor.
Decision Self-Efficacy Scale MeasureLink provided by the sponsor.
Usability Scale MeasureLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary C Politi, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Decision Aid in people with Hepatitis C and Chronic Kidney Diseases, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knowledge (time frame: At baseline and immediately after viewing the intervention, within 30 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426787, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.