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临床试验/NCT03278821
NCT03278821已完成不适用

A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study

Kjeld Andersen2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Reduced amount of drinking days measured by Time Line Follow Back.

研究概览

简要总结

The purpose of this study is to determine whether patient self-matching (as compared with treatment as usual by expert matching) improves quality of life, retention, and outcome for patients being treated for alcohol problems.

There are at least two good reasons for offering patients a choice when the goal is a change in their behavior. The first is that patients are likely to know what treatment works best for them. Secondly, being allowed to choose between options may increase compliance in treatment. As a randomized controlled trial, this study will compare the efficacy of patient self-matching versus treatment-as-usual expert matching.

The Self-Match Study is expected to increase knowledge on the importance of involving the alcohol dependent patient in choosing what treatment method is best for him/her instead of having experts to do that. The investigators expect to discover patient involvement as a way to improve compliance in treatment, hence preventing that patients drop out of treatment to early. If this hypothesis proves to be right, clinicians will have a viable strategy for matching treatment methods to patients, since the strategy does not demand further resources in the treatment system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

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

  • Fulfilling DSM-IV criteria for alcohol abuse or dependence.
  • Native Danish speaking.
  • Having no severe psychosis or cognitive impairment.
  • Accepting to participate in the study.

排除标准

  • 未提供

研究组 & 干预措施

Expert Match

Active Comparator

The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.

干预措施: Expert Match (Behavioral)

Self Match

Experimental

The patient must choose between the five possible treatment options.

干预措施: Self Match (Behavioral)

结局指标

主要结局

Reduced amount of drinking days measured by Time Line Follow Back.

时间窗: 6 months after initiation of treatment.

The primary endpoint analysis will be a comparison of outcomes for patients assigned to the self-match group vs. expert-match group to determine whether self-matching yields more favorable outcome than expert matching, measured by the number of excessive drinking days.

次要结局

  • Quality of life measured by WHO's Quality of Life scale.(6 months after treatment start.)
  • Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.(6 months after treatment start.)
  • Compliance measured by proportion of patients who has completed treatment.(6 months after treatment start)
  • Personality traits, measured by NEO-FFI-3, influence on outcome.(6 months after treatment start.)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kjeld Andersen

Professor

University of Southern Denmark

研究点 (2)

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