CClinicalTrials.gg
CompletedNCT03320889Updated Aug 28, 2019

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

An interventional study of Educational Intervention in Hepatitis C, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Patients who do not speak and understand English.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Other
    Pamphlets plus Review with Expert Educator

    Educational Intervention includes Pamphlets plus Review with Expert Educator

    Other: Educational Intervention

  • Other
    Pamphlets only

    Educational Intervention includes Pamphlets only

    Other: Educational Intervention

Interventions

  • OtherEducational 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.

05

What researchers measure

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

    Time frame: 2-8 weeks after study intervention

06

Study locations

1 site
  • Good Samaritan Hospital
    Cincinnati, Ohio 45220, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03320889
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Oct 30, 2017
Primary completion
Aug 26, 2019
Completion
Aug 26, 2019
Last update
Aug 28, 2019

Study contacts

Michael Marcotte, MD
principal investigator · TriHealth Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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