Alcohol-related Liver DiseaseNCT06183710
Contingency Management to Incentivise Treatment Adherence in Alcohol-related Liver Disease
A study testing Contingency management in people with Alcohol-related Liver Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-related Liver Disease
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 30 Sep 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or above.
- Able to communicate in English independently.
- Formal diagnosis of ARLD in line with ICD-10 K70 codes (fatty liver, hepatitis, fibrosis, sclerosis, cirrhosis, hepatic failure, unspecified liver disease) upon discharge following acute liver disease episode.
- Formal diagnosis of AD in line with ICD-10 F10.2 codes.
- Attending South London liver services (King's Health Partners).
- Able and willing to provide informed consent.
- Able and willing to participate in study.
- Owning a mobile phone.
Who cannot join
- Less than 18 years old.
- Current dependence on other substances other than alcohol, tobacco, or cannabis.
- Inability to communicate in English independently.
- Being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Contingency Management to Incentivise Adherence to Treatment in Alcohol-related Liver Disease: a Mixed-methods Study
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.
Read the 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 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.
- Conditions
- Alcohol-related Liver Disease
- Being tested
- Contingency management
- Keywords
- Contingency management, Alcohol-use Disorder, Psychosocial intervention, Treatment adherence
- Medical subject headings
- Alcoholism, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Psychosocial intervention
| Study group | Role | What they receive |
|---|---|---|
| Integrated care only (control group) | No intervention | The integrated care comprises of 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 |
| Integrated care + CM | Experimental | The integrated care comprises of 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 over the course of 3 months Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility rates
Quantitative data: eligibility and consent rates (number and percentage of screened patients who are eligible for inclusion in the study, number and percentage of eligible patients who consent to participate), recruitment rate (number of patients recruited each week over the recruitment period), intervention compliance (number and percentage of intervention sessions delivered to each of the enrolled participants) follow-up rates (number and percentage of participants followed up for research interview at 3 and 6-month follow-ups), drop-out rate (number and percentage of participants dropping out if assigned to control group)
Measured: 1 year
Acceptability
Qualitative data (in-depth interviews): acceptability of CM intervention, perceived experience, treatment experience Quantitative data: Theoretical Framework for Acceptability survey (descriptive statistics)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related Liver DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, individually randomized pilot trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Drummond, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183710
- Sponsor's protocol ID
- IRAS ID 314351
- Status last verified
- Feb 2024
- First submitted
- 4 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Contingency Management to Incentivise Adherence to Treatment in Alcohol-related Liver Disease: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06183710
- Acronym / sponsor ID
- IRAS ID 314351
- Conditions
- Alcohol-related Liver Disease
- Keywords
- Contingency management, Alcohol-use Disorder, Psychosocial intervention, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Dec 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 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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, individually randomized pilot trial
| Arm | Type | Receives |
|---|---|---|
| Integrated care only (control group) | No intervention | –The integrated care comprises of 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 |
| Integrated care + CM | Experimental | Behavioral: Contingency managementThe integrated care comprises of 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 over the course of 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old or above.
- Able to communicate in English independently.
- Formal diagnosis of ARLD in line with ICD-10 K70 codes (fatty liver, hepatitis, fibrosis, sclerosis, cirrhosis, hepatic failure, unspecified liver disease) upon discharge following acute liver disease episode.
- Formal diagnosis of AD in line with ICD-10 F10.2 codes.
- Attending South London liver services (King's Health Partners).
Key exclusion criteria (4 listed)
- Less than 18 years old.
- Current dependence on other substances other than alcohol, tobacco, or cannabis.
- Inability to communicate in English independently.
- Being pregnant.
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 |
|---|---|---|
| Contingency managementPsychosocial intervention | Behavioural | Integrated care + CM |
Primary outcome
Feasibility rates
Time frame: 1 year
Quantitative data: eligibility and consent rates (number and percentage of screened patients who are eligible for inclusion in the study, number and percentage of eligible patients who consent to participate), recruitment rate (number of patients recruited each week over the recruitment period), intervention compliance (number and percentage of intervention sessions delivered to each of the enrolled participants) follow-up rates (number and percentage of participants followed up for research interview at 3 and 6-month follow-ups), drop-out rate (number and percentage of participants dropping out if assigned to control group)
Acceptability
Time frame: 1 year
Qualitative data (in-depth interviews): acceptability of CM intervention, perceived experience, treatment experience Quantitative data: Theoretical Framework for Acceptability survey (descriptive statistics)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- 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.
Colin Drummond principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Alcohol-related Liver Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 4 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility rates (time frame: 1 year). 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 7 Feb 2024.