CClinicalTrials.gg
Status unknownNCT04029246Updated Jul 23, 2020

Re-engaging Patients With Hepatitis C Into Care

An interventional study of Follow up phone call and Incentive in Hepatitis C, Chronic, sponsored by Glasgow Royal Infirmary. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years to 110 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Glasgow Royal Infirmary · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
16 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
16 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 16 years or older
  • Known hepatitis C infection which is either:
  • untreated
  • treated but the outcome of treatment unknown

Exclusion criteria

Exclusion Criteria:

  • Known HIV infection
  • No longer resident within NHS Greater Glasgow and Clyde area
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (actual)

Study arms

  • No intervention
    Letter only
  • Active comparator
    Letter plus phone call

    Behavioral: Follow up phone call

  • Active comparator
    Letter plus incentive

    Behavioral: Incentive

Interventions

  • BehavioralFollow up phone call

    Telephone call to ask if patient has received letter and whether they would like an appointment

  • BehavioralIncentive

    Offer of a shopping voucher if patient attends for appointment

05

What researchers measure

Primary outcomes

  1. Rate of attendance for liver assessment

    Rates of attendance for assessment of liver disease within a 4 month period, recorded as a binary (yes/no) outcome

    Time frame: 4 months

Secondary outcomes

  1. Rates of initiation of Hepatitis C treatment

    Rates of initiation of treatment for hepatitis C within a 6 month period, recorded as a binary (yes/no) outcome.

    Time frame: 6 months

06

Study locations

1 site
  • Glasgow Royal Infirmary
    Glasgow, United Kingdom
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 29, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04029246
Lead sponsor
Glasgow Royal Infirmary
Collaborators
Glasgow Caledonian University
Responsible party
stephen t barclay (Consultant Hepatologist, Glasgow Royal Infirmary) — Principal investigator
First posted
Jul 23, 2019
Start date
Nov 1, 2019
Primary completion
Aug 1, 2020 (estimated)
Completion
Aug 1, 2020 (estimated)
Last update
Jul 23, 2020

Study contacts

Stephen T Barclay, MBChB
principal investigator · NHS Greater Glasgow and Clyde

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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