NCT03320889

Brief Summary

The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

October 2, 2017

Last Update Submit

August 26, 2019

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of Questions Scored Correct on the Hepatitis C Knowledge Survey

    Number of questions scored correct on the Hepatitis C knowledge survey

    2-8 weeks after study intervention

Study Arms (2)

Pamphlets plus Review with Expert Educator

OTHER

Educational Intervention includes Pamphlets plus Review with Expert Educator

Other: Educational Intervention

Pamphlets only

OTHER

Educational Intervention includes Pamphlets only

Other: Educational Intervention

Interventions

Educational InterventionOTHER

Patients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions.

Pamphlets onlyPamphlets plus Review with Expert Educator

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older.
  • The study will include patients with and without a Hepatitis C diagnosis.
  • Patients will be recruited at their routine office visits and/or during any admissions to the hospital.

You may not qualify if:

  • Patients who do not speak and understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Michael Marcotte, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 25, 2017

Study Start

October 30, 2017

Primary Completion

August 26, 2019

Study Completion

August 26, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)