Patient Knowledge, Beliefs and Barriers to Hepatitis D Care

Hepatitis, Delta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06017375
• Other study ID #: 330645
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: August 2023
• Source: King's College Hospital NHS Trust
• Contact: Sital Shah
• Phone: 02032999000
• Email: sitalshah[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 113
• Est. completion date: August 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis, Delta

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall patient understanding of Hepatitis D Virus diagnosis	Use of modified CLDQ - HBV survey. Scale of 1-7 with lower scores indicating worse outcomes	6 months
Primary	Describe overall patient knowledge around HDV	Modified HBV knowledge scale survey. Yes or No as options	6 months
Secondary	Describe stigma attached towards HDV	Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always	6 months
Secondary	Understand satisfaction with communication regarding HDV care at KCH	Use of local viral hepatitis service questionnaire	6 months