Patient Knowledge, Beliefs and Barriers to Hepatitis D Care

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06017375
Collaborator
(none)
113
12

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire based intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
113 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Outcome Measures

Primary Outcome Measures

  1. The overall patient understanding of Hepatitis D Virus diagnosis [6 months]

    Use of modified CLDQ - HBV survey. Scale of 1-7 with lower scores indicating worse outcomes

  2. Describe overall patient knowledge around HDV [6 months]

    Modified HBV knowledge scale survey. Yes or No as options

Secondary Outcome Measures

  1. Describe stigma attached towards HDV [6 months]

    Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always

  2. Understand satisfaction with communication regarding HDV care at KCH [6 months]

    Use of local viral hepatitis service questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • King's College Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT06017375
Other Study ID Numbers:
  • 330645
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023