Hepatitis CNCT04204447

Hepatitis C-Video vs. Brochure Education Delivery

A study testing Hepatitis C Educational Brochure and Hepatitis C Educational Video in people with Hepatitis C, run by State University of New York at Buffalo at 2 sites 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

The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Hepatitis C Educational Brochure and Hepatitis C Educational Video
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: 2 sitesUnited States
Study dates: 27 Nov 2019to 31 Oct 2020
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

Currently on active treatment for opioid addiction/use
English as primary language

Who cannot join

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University at Buffalo
Buffalo, New York, 14203
BestSelf Behavioral Health
Orchard Park, New York, 14127

Other trials in United States

About this study

Official title: A Prospective Study Showing the Effect of Video Interactive Education on Medical Decision Making in Patients on Opiate Replacement Therapy (ORT) With a History of Hepatitis C

Read the detailed description

Subjects will complete 3 questionnaires, including one about knowledge of Hepatitis C. The subject will then either watch a video or read a brochure about Hepatitis C, then take the same questionnaire again. The subject will then return in one month to take the Hepatitis C questionnaire again.

Conditions: Hepatitis C
Being tested: Hepatitis C Educational Brochure, Hepatitis C Educational Video
Medical subject headings: Hepatitis C

What participants receive

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

Hepatitis C Educational BrochureOther
Subjects will receive information about Hepatitis C through a brochure
Hepatitis C Educational VideoOther
Subjects will receive information about Hepatitis C through a video

Study groups in NCT04204447
Study group	Role	What they receive
Brochure intervention	Experimental	Subjects will be asked to read an educational brochure about Hepatitis C Receives: Other: Hepatitis C Educational Brochure
Video intervention	Experimental	Subjects will be asked to watch an educational video about Hepatitis C Receives: Other: Hepatitis C Educational Video

What is being measured

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

Improvement in Scores on HCV Knowledge Questionnaire
The main outcome measure was a change in the mean score on a 25-item HCV knowledge assessment without subscales. The instrument values ranged from 0 to 25 with one point per correct answer to questions directly arising from the information contained in the video. One point was assigned to each correct answer, and an increase in the score indicated more correct responses.
Measured: Pre-intervention, Immediate post-intervention, and 1 mo. follow up

Timeline

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

27 Nov 201931 Oct 2020

First posted19 Dec 2019
Study start27 Nov 2019
Primary completion31 Oct 2020
Study completion31 Oct 2020

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.
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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04204447
Sponsor's protocol ID: STUDY00002677
Status last verified: Apr 2024
First submitted: 13 Dec 2019
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared

Publications

Talal AH, Ding YX, Markatou M. Innovations in education: A prospective study of storytelling narratives to enhance hepatitis C virus knowledge among substance users. World J Hepatol. 2022 May 27;14(5):972-983. doi: 10.4254/wjh.v14.i5.972.
PubMed 35721284

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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study Showing the Effect of Video Interactive Education on Medical Decision Making in Patients on Opiate Replacement Therapy (ORT) With a History of Hepatitis C
ClinicalTrials.gov ID: NCT04204447
Acronym / sponsor ID: STUDY00002677
Conditions: Hepatitis C
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Study start: 27 Nov 2019 (actual)
Primary completion: 31 Oct 2020 (actual)
Study completion: 31 Oct 2020 (actual)
First posted: 19 Dec 2019 (actual)
Results: Posted 19 Sep 2024

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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Brochure intervention	Experimental	Other: Hepatitis C Educational BrochureSubjects will be asked to read an educational brochure about Hepatitis C
Video intervention	Experimental	Other: Hepatitis C Educational VideoSubjects will be asked to watch an educational video about Hepatitis C

Who may qualify

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

Key inclusion criteria (2 listed)

Currently on active treatment for opioid addiction/use
English as primary language

Key exclusion criteria (1 listed)

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
Hepatitis C Educational BrochureSubjects will receive information about Hepatitis C through a brochure	Other	Brochure intervention
Hepatitis C Educational VideoSubjects will receive information about Hepatitis C through a video	Other	Video intervention

Primary outcome

Improvement in Scores on HCV Knowledge Questionnaire
Time frame: Pre-intervention, Immediate post-intervention, and 1 mo. follow up
The main outcome measure was a change in the mean score on a 25-item HCV knowledge assessment without subscales. The instrument values ranged from 0 to 25 with one point per correct answer to questions directly arising from the information contained in the video. One point was assigned to each correct answer, and an increase in the score indicated more correct responses.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brochure Intervention	90	83
Video Intervention	86	81

Primary outcome: Improvement in Scores on HCV Knowledge Questionnaire

Time frame: Pre-intervention, Immediate post-intervention, and 1 mo. follow up. Mean (Standard Deviation). Unit: Improvement in scores

Measure	Brochure Intervention n = 90	Video Intervention n = 86
Pre-intervention	18.45 (.3)	19 (0.25)
Immiediate post-intervention	20.3 (.35)	21.75 (0.3)
One month post-intervention	20.2 (.3)	21.7 (0.2)

Adverse events

Time frame: 4-6 weeks-Time between the pre-intervention assessment and the post-intervention assessment obtained one month post-intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video Intervention	0 of 86 (0%)	0 of 86 (0%)	0 of 86
Brochure Intervention	0 of 90 (0%)	0 of 90 (0%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35721284Talal AH, Ding YX, Markatou M. Innovations in education: A prospective study of storytelling narratives to enhance hepatitis C virus knowledge among substance users. World J Hepatol. 2022 May 27;14(5):972-983. doi: 10.4254/wjh.v14.i5.972.
Individual participant dataSharing planned: No. IPD will not be shared

Related trials for Hepatitis C

Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
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Active, not recruitingPhase 4
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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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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.

Andrew Talal, MD principal investigator

SUNY University at Buffalo

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

Questions about this trial

What is this clinical trial studying?

A study testing Hepatitis C Educational Brochure and Hepatitis C Educational Video in people with Hepatitis C, run by State University of New York at Buffalo at 2 sites 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 1 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 19 Sep 2024). 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?

Improvement in Scores on HCV Knowledge Questionnaire (time frame: Pre-intervention, Immediate post-intervention, and 1 mo. follow up). 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 NCT04204447, 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 19 Sep 2024.