Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2

NCT ID: NCT03320889

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2019-08-26

Brief Summary

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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.

Detailed Description

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The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pamphlets plus Review with Expert Educator

Educational Intervention includes Pamphlets plus Review with Expert Educator

Group Type OTHER

Educational Intervention

Intervention Type OTHER

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 only

Educational Intervention includes Pamphlets only

Group Type OTHER

Educational Intervention

Intervention Type OTHER

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.

Interventions

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Educational Intervention

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who do not speak and understand English.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Marcotte, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-057

Identifier Type: -

Identifier Source: org_study_id

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