跳至主要内容
临床试验/NCT06381609
NCT06381609尚未招募不适用

Contribution of Addiction Peer Support on Adherence to Care and Clinical Outcomes in Alcohol Dependence: a Prospective Controlled Trial With Medico-economic Component

Hospices Civils de Lyon10 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
626
试验地点
10
主要终点
Unplanned cessation of care at 6 months

研究概览

简要总结

Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.

However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.

Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.

Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.

This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Aged ≥ 18
  • Socially insured
  • Meeting DSM-5 criteria for alcohol use disorder (AUD)
  • Abstinent from alcohol and involved in supervised alcohol withdrawal for at least 5 days and no more than 21 days (outpatient or inpatient)
  • Starting a post-detoxification outpatient program

排除标准

  • Other severe substance use disorder, i.e. DSM-5 criteria ≥ 6 (excluding tobacco)
  • Patient under protective measure (safeguard measure, guardianship) or deprived of liberty or in ordered care and hospitalization measures without consent.
  • Inability to communicate and express oneself orally in French, compromising the possibility of exchanges between the Peer support and the patient.
  • Psychiatric or cognitive comorbidities making inclusion impossible, at the investigator's discretion.
  • Individual accompaniment by a Peer support in the 15 days prior to inclusion.

结局指标

主要结局

Unplanned cessation of care at 6 months

时间窗: At 6 months after inclusion

The unplanned cessation of care at 6 months, excluding consultations with an APSS, with no further contact in the following month, is defined as having had a last planned consultation that was not fulfilled between M0 and M6

次要结局

  • average number of standard drinks declared per week(At inclusion, 3 and 6 months after inclusion)
  • Euroqol-5D-5L questionnaire score(At inclusion, 3 and 6 months after inclusion)
  • Difference in costs (in euros)(At 1, 2 and 3 years after the beginning of implementation on French territory)
  • Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score(At inclusion, 3 and 6 months after inclusion)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) score(At inclusion, 3 and 6 months after inclusion)
  • type of psychostimulant use(At inclusion, 3 and 6 months after inclusion)
  • State-Trait Anxiety Inventory (STAI-Y) score(At inclusion, 3 and 6 months after inclusion)
  • Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score(At inclusion, 3 and 6 months after inclusion)
  • frequency of opioid use(At inclusion, 3 and 6 months after inclusion)
  • Health Care Satisfaction Questionnaire (HCSQ) score(At 6 months after inclusion)
  • Alcohol Quality of Life Scale (AQoLS) score(At inclusion, 3 and 6 months after inclusion)
  • type of opioid use(At inclusion, 3 and 6 months after inclusion)
  • frequency of psychostimulant use(At inclusion, 3 and 6 months after inclusion)
  • Number of unfulfilled consultations(6 months after inclusion)
  • Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)(At inclusion, 3 and 6 months after inclusion)
  • Fagerström test score(At inclusion, 3 and 6 months after inclusion)
  • Service organization description(Before setting up of the study)
  • AIM score(At 6 months after inclusion)
  • Adoption of intervention(After last visit of last patient (around 3,5 years after first inclusion))
  • Intervention fidelity(After last visit of last patient (around 3,5 years after first inclusion))
  • Number of hospitalisations(At 6 months after inclusion)
  • Description of type of support and missions performed by Peer Support(After last visit of last patient (around 3,5 years after first inclusion))
  • Acceptability of Intervention Measure (AIM) score(After last visit of last patient (around 3,5 years after first inclusion))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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