Contingency Management to Incentivise Treatment Adherence in Alcohol-related Liver Disease

NCT06183710 | Active Not Recruiting

• 1 other identifier: IRAS ID 314351
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-related Liver Disease

Keywords

Contingency management; Alcohol-use Disorder; Psychosocial intervention; Treatment adherence

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  1 year

Study Arms (2)

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

Behavioral: Contingency management

Interventions

Contingency management BEHAVIORAL

Psychosocial intervention

Integrated care + CM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Less than 18 years old.
• Current dependence on other substances other than alcohol, tobacco, or cannabis.
• Inability to communicate in English independently.
• Being pregnant.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Colin Drummond

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, individually randomized pilot trial

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: September 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)