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Patient Knowledge, Beliefs and Barriers to Hepatitis D Care

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: NCT06017375
Recruitment Status : Not yet recruiting
First Posted : August 30, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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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
Hepatitis, Delta 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
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Study Type : Observational
Estimated Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Questionnaire based intervention
    Three validated questionnaires amended from hepatitis B to D (Chronic liver disease questionnaire, self-stigma scale and HBV virus knowledge scale) will be used.

Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Describe overall patient knowledge around HDV [ Time Frame: 6 months ]
    Modified HBV knowledge scale survey. Yes or No as options


Secondary Outcome Measures :
  1. Describe stigma attached towards HDV [ Time Frame: 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 [ Time Frame: 6 months ]
    Use of local viral hepatitis service questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with past or current hepatitis D virus infection
Criteria

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
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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): NCT06017375


Contacts
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Contact: Sital Shah 02032999000 ext 35714 sitalshah@nhs.net

Sponsors and Collaborators
King's College Hospital NHS Trust
More Information
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT06017375    
Other Study ID Numbers: 330645
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: August 2023
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 A
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections