Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-12-04
Brief Title:
Contingency Management to Incentivise Treatment Adherence in Alcohol-related Liver Disease
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Adjunctive Contingency Management to Incentivise Adherence to Treatment in Alcohol-related Liver Disease a Mixed-methods Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 distressclinically 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 Kings 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 participants 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 clinicians 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
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 distressclinically 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 Kings 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 participants 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 clinicians 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None