Adjunctive Contingency Management to Incentivise Adherence to Treatment in Alcohol-related Liver Disease: a Mixed-methods Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility rates
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Less than 18 years old.
- •Current dependence on other substances other than alcohol, tobacco, or cannabis.
- •Inability to communicate in English independently.
- •Being pregnant.
结局指标
主要结局
Feasibility rates
时间窗: 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
时间窗: 1 year
Qualitative data (in-depth interviews): acceptability of CM intervention, perceived experience, treatment experience Quantitative data: Theoretical Framework for Acceptability survey (descriptive statistics)
次要结局
未报告次要终点