Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1

August 26, 2019 updated by: TriHealth Inc.
The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will compare the effectiveness of 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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Study population includes obstetrics patients enrolled in the HOPE program who are 18 years old or older.

Description

Inclusion Criteria

  • The study will include patients with and without Hepatitis C diagnosis.
  • Patients will be recruited at their routine prenatal and post-partum visits.
  • Patients who speak and understand English

Exclusion Criteria:

  • Patients under the age of the 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovering the gaps in patients' knowledge of Hepatitis C
Time Frame: 2 months
Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Investigators

  • Principal Investigator: Michael Marcotte, MD, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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