Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06183710 |
| Other study ID # |
IRAS ID 314351 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
King's College Hospital NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A sample of 30 alcohol-related liver disease patients will be recruited through consecutive
sampling, facilitated through the Alcohol Care Team, which will identify potential
participants to the study that have been referred to the team.
Patients will be randomised either to the control or intervention group. In the control
group, patients will receive outpatient integrated liver care (hepatology, psychosocial and
addiction follow-ups). In the intervention group, a contingency management intervention will
be delivered in addition to integrated care.
Description:
A sample of 30 ARLD patients will be recruited through consecutive sampling, facilitated
through the ACT, who will identify potential participants to the study that have been
referred to the team. The ACT will give service users a study advert and patient information
sheet (PIS). If consented, the contact details will be passed on to the research team, who
will contact potential participants. A maximum of three attempts to contact a participant
will be made at each planned follow-up point (3 and 6 months).
Following referral to the study, the research student will contact the potential participant
via telephone to discuss the study. The purpose of the call is to provide further details of
the research, confirm whether the service user wishes to take part in the research and
provide a Patient Information Sheet (PIS). The research student will allow the potential
participant to clarify any initial questions related to the research and proceed to arrange
an initial assessment appointment. This appointment will be set at least 24 hours after the
service user receives the PIS to allow for further consideration.
When a potential participant is identified and referred to the ACT while in the emergency
department, the ACT clinician will discuss the study with the patient and provide the PIS.
The point at which the study is discussed with the patient may vary. This will be assessed on
an individual basis by the ACT clinician, to prevent approaching patients prematurely, or if
they are in distress/clinically unstable. Patients will not be approached by clinical staff
about taking part in the study if they are in distress or clinically unstable.
If the patient agrees, the contact details will be passed to the research team, who will
follow up to confirm interest in the study and obtain informed consent. This contact attempt
is to be made at least 24 hours after the potential participant receives the study PIS.
Following study enrolment, subjects will be randomised to either:
Treatment arm 1: Integrated care only (control group) OR Treatment arm 2: Integrated care +
CM (intervention group). The integrated care comprises standard treatment offered at the
Integrated Treatment Clinic at King's College Hospital and includes addiction and liver
follow-up as well as facilitation of psychosocial sessions. The adjunctive CM aims to
reinforce attendance to integrated alcohol and liver care services from KCH for 3 months,
with follow-up times at 3- and 6-months.
The use of vouchers, redeemable for goods other than alcohol or tobacco, to reward a specific
behaviour is effective and regarded as being easier to implement in the NHS. The
participant's attendance will be monitored by liaising with the involved treatment services
(administrative task), and the incentive will be delivered by the research team, hence not
interfering with the clinician's daily workflow. After confirming the attendance, the
participant will be notified via text message of the awarded voucher, the number of sessions
attended and the total prize value to date, and the total prize amount to be awarded by the
end of the study.
