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Re-engaging Patients With Hepatitis C Into Care - Trial NCT04029246

Access comprehensive clinical trial information for NCT04029246 through Pure Global AI's free database. This phase not specified trial is sponsored by Glasgow Royal Infirmary and is currently Not yet recruiting. The study focuses on Hepatitis C, Chronic. Target enrollment is 1000 participants.

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NCT04029246
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT04029246
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Re-engaging Patients With Hepatitis C Into Care
Reengaging Patients With Previously Diagnosed Hepatitis C in to Care

Study Focus

Hepatitis C, Chronic

Follow up phone call

Interventional

behavioral

Sponsor & Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Timeline & Enrollment

N/A

Nov 01, 2019

Aug 01, 2020

1000 participants

Primary Outcome

Rate of attendance for liver assessment

Summary

Aims:
 
 To evaluate the impact of a letter, phone call and incentive in re-engaging patients with
 hepatitis C care.
 
 Outcomes of interest:
 
 Primary outcome of interest:
 
 - Attendance for assessment of liver disease within 4 months of being sent invitation letter.
 
 Secondary outcomes of interest:
 
 - Commencing treatment within 6 months of being sent invitation letter.
 
 Methods:
 
 Patient identification:
 
 The local copy of the Scottish Hepatitis C database holds data regarding patients referred to
 secondary care for treatment of their hepatitis C, and holds ethics approval for research on
 treatment and patient outcomes. This will be used to identify patients with hepatitis C
 infection that is untreated, treatment has been unsuccessful, or the patient has been treated
 but the outcome is unknown (due to non attendance for blood tests). The database has been
 cross checked with virus lab results, to ensure infection status is up to date. Finally, the
 patient data has been checked by NHS GG&C information team, to exclude patients who are
 deceased, or whom are no longer resident in NHS greater Glasgow and Clyde based on updated
 details obtained from SCIstore.
 
 Inclusion criteria:
 
 Patients (16 years and over) who have previously engaged with Hepatitis C services in Glasgow
 but who are either untreated, have been treated unsuccessfully, or have been treated but have
 not attended for blood tests to check for treatment success.
 
 Exclusion criteria:
 
 Patients with HIV. Patients no longer resident within NHS Greater Glasgow and Clyde area.
 
 Allocation to contact groups:
 
 Patients will be randomly distributed into 3 groups:
 
 1. Letter: Will be sent letter 1 (appendix)
 
 2. Letter plus telephone call: will be sent letter 2 (appendix) and be followed up with a
 telephone call from the treatment centre if no contact has been received after 4 weeks
 
 3. Letter plus incentive: will be sent letter 3 (appendix)
 
 Process:
 
 Patient letters will be sent out by GG&C public health. For all 3 groups the letter will be
 sent with the small Hepatitis C Scotland booklet Hepatitis C treatments have changed.
 
 Letters will identify include the telephone number for the identified treatment centre which
 will be either, the last known treatment centre or a more local treatment centre were
 appropriate based on current residence.
 
 Primary and secondary outcomes measures will be collected via the Scottish Hepatitis C
 database.
 
 Lay Summary:
 
 This study will test whether a letter alone, a letter plus follow up phone call or a letter
 with offer of incentive, will be most effective in re-engaging patients who are known to have
 hepatitis C but not yet received treatment.

ICD-10 Classifications

Chronic viral hepatitis C
Acute hepatitis C
Chronic hepatitis, unspecified
Chronic viral hepatitis
Chronic viral hepatitis, unspecified

Data Source

ClinicalTrials.gov

NCT04029246

Non-Device Trial