Patient Knowledge, Beliefs and Barriers to Hepatitis D Care

August 29, 2023 updated by: King's College Hospital NHS Trust

Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study

A project to understand the determinants of health behaviour among those with chronic hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings College Hospital (KCH). This is to improve and implement pathways and patient information distribution to improve access to care in an ethnically diverse population living with HDV in the UK.

Kings college hospital NHS Foundation Trust is uniquely placed and serves a large diverse population from areas such as pan pacific Asia, Eastern Europe and regions in Africa, where English is not their first language. This diversity is also seen in other London Hospitals but less so in other parts of the UK.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To understand the knowledge patients have around their diagnosis of hepatitis D which is considered a rare disease but the most aggressive form of viral hepatitis. In order to improve the management of hepatitis D, this research aims to identify the current knowledge patients have about their diagnosis, the information provided to them in their preferred language, how they feel about their diagnosis and the stigma attached. This research has been conducted in patients with other forms of viral hepatitis but not in patients living with hepatitis D. There is a lack of research in this area. With this research we aim to improve treatment pathways, access to care and to information.

Study Type

Observational

Enrollment (Estimated)

113

Contacts and Locations

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

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with past or current hepatitis D virus infection

Description

Inclusion Criteria:

  • Participants 18 years or older.
  • HDV infection as diagnosed by high levels of anti-HDV immunoglobulin G (IgG) and immunoglobulin M (IgM), and confirmed by detection of HDV RNA in serum.
  • Treated HDV infection
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall patient understanding of Hepatitis D Virus diagnosis
Time Frame: 6 months
Use of modified CLDQ - HBV survey. Scale of 1-7 with lower scores indicating worse outcomes
6 months
Describe overall patient knowledge around HDV
Time Frame: 6 months
Modified HBV knowledge scale survey. Yes or No as options
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe stigma attached towards HDV
Time Frame: 6 months
Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always
6 months
Understand satisfaction with communication regarding HDV care at KCH
Time Frame: 6 months
Use of local viral hepatitis service questionnaire
6 months

Collaborators and Investigators

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

Sponsor

King's College Hospital NHS Trust

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 330645

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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Locations

3
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