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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03320889
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Educational Intervention Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pamphlets plus Review with Expert Educator
Educational Intervention includes Pamphlets plus Review with Expert Educator
Other: 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.

Pamphlets only
Educational Intervention includes Pamphlets only
Other: 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.




Primary Outcome Measures :
  1. Number of Questions Scored Correct on the Hepatitis C Knowledge Survey [ Time Frame: 2-8 weeks after study intervention ]
    Number of questions scored correct on the Hepatitis C knowledge survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320889


Contacts
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Contact: Ganga Devaiah, MS 513-862-2341 ganga_devaiah@trihealth.com
Contact: Amy Knapp-Jones, MSN, RN 513-865-1148 amy_knapp-jones@trihealth.com

Locations
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United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Michael Marcotte, MD    513-862-4490    michael_marcotte@trihealth.com   
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Michael Marcotte, MD TriHealth Inc.

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03320889     History of Changes
Other Study ID Numbers: 17-057
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders