Back to resultsHepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Hepatitis C
Eligibility 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.
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pamphlets plus Review with Expert Educator
Pamphlets only
Arm Description
Educational Intervention includes Pamphlets plus Review with Expert Educator
Educational Intervention includes Pamphlets only
Outcomes
Primary Outcome Measures
Number of Questions Scored Correct on the Hepatitis C Knowledge Survey
Number of questions scored correct on the Hepatitis C knowledge survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03320889
Brief Title
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Official Title
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pamphlets plus Review with Expert Educator
Arm Type
Other
Arm Description
Educational Intervention includes Pamphlets plus Review with Expert Educator
Arm Title
Pamphlets only
Arm Type
Other
Arm Description
Educational Intervention includes Pamphlets only
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
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 Measure Information:
Title
Number of Questions Scored Correct on the Hepatitis C Knowledge Survey
Description
Number of questions scored correct on the Hepatitis C knowledge survey
Time Frame
2-8 weeks after study intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Marcotte, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
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