Hepatitis, DeltaNCT06017375
Patient Knowledge, Beliefs and Barriers to Hepatitis D Care
An observational study of Hepatitis, Delta, run by King's College Hospital NHS Trust.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Delta
- What is being tested?
- Questionnaire based intervention
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with past or current hepatitis D virus infection
Who may be able to join
- 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.
Who cannot join
- Clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis, Delta
- Being tested
- Questionnaire based intervention
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire based interventionOther
Three validated questionnaires amended from hepatitis B to D (Chronic liver disease questionnaire, self-stigma scale and HBV virus knowledge scale) will be used.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Describe overall patient knowledge around HDV
Modified HBV knowledge scale survey. Yes or No as options
Measured: 6 months
Secondary outcomes (2)
Describe stigma attached towards HDV
Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always
Measured: 6 months
Understand satisfaction with communication regarding HDV care at KCH
Use of local viral hepatitis service questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, DeltaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017375
- Sponsor's protocol ID
- 330645
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study
- ClinicalTrials.gov ID
- NCT06017375
- Acronym / sponsor ID
- 330645
- Conditions
- Hepatitis, Delta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with past or current hepatitis D virus infection
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire based interventionThree validated questionnaires amended from hepatitis B to D (Chronic liver disease questionnaire, self-stigma scale and HBV virus knowledge scale) will be used. | Other | – |
Primary outcome
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
Describe overall patient knowledge around HDV
Time frame: 6 months
Modified HBV knowledge scale survey. Yes or No as options
2 secondary outcomes
Describe stigma attached towards HDV
Time frame: 6 months
Understand satisfaction with communication regarding HDV care at KCH
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, Delta, run by King's College Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sital Shah (02032999000 ext. 35714, sitalshah@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall patient understanding of Hepatitis D Virus diagnosis (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.