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临床试验/NCT01780116
NCT01780116已完成1 期

An Evaluation of the Effectiveness of Adherence Therapy for Schizophrenia: A Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
134
试验地点
2
主要终点
re-hospitalization rate

研究概览

简要总结

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in: level of medication adherence, readmission rate, mental status, insight into treatment, and level of functioning.

详细描述

When compared with those in the control (usual care) group, participants in the AT group are expected to demonstrate significant improvements immediately and at three, six and 12 months after completion of the intervention in the following aspects:

  1. level of adherence to antipsychotic medication,
  2. rate and length of psychiatric hospital readmission,
  3. mental status,
  4. insight and attitude into illness and treatment, and
  5. level of functioning.

The primary outcomes are level of antipsychotic medication adherence, re-hospitalization rates and mental status; and the patients' drug attitude will be the mediating factor of the AT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •of the patients include those who:
  • •are Hong Kong Chinese residents;
  • •have a primary diagnosis of schizophrenia or its subtypes such as schizophreniform and schizoaffective disorders not more than 3 years;
  • •have been prescribed oral antipsychotics for at least 1 month;
  • •are aged 18-65 years;
  • •have Positive and Negative Syndrome Scale (PANSS) score >60 and are judged by the case Community Psychiatric Nurse/psychiatrist as non-adherents; and
  • •are able to understand Cantonese/Mandarin.
  • •Patients will be excluded if they have:
  • •only depot/intramuscular injections as regular psychiatric medication;
  • •co-morbidity of learning disability and organic brain disease, or clinically significant medical diseases;
  • •participated in adherence therapy; and/or
  • •visual, language or communication difficulty.

排除标准

  • 未提供

研究组 & 干预措施

Medicaiton adherence therapy

Experimental

Adherence therapy, consisting of six, 2-hour sessions over 3 months, in three phases:

  1. Engaging patients: assessing needs and concerns in medication adherence;
  2. Reviewing strengths and barriers and developing coping strategies; and
  3. Rationalizing beliefs and concerns and preventing relapse.

干预措施: Adherence therapy (Behavioral)

Routine community care

No Intervention

Routine Community psychiatric nursing services provided by the Community Psychiatric Nurses in the practice field

结局指标

主要结局

re-hospitalization rate

时间窗: 12 months after completion of intervention

rate and length of psychiatric hospital readmission immediately, 6 months and 12 months after the completion of the intervention undertaken

次要结局

  • mental status(12 months follow-up)
  • insight into treatment(12 months follow-up)
  • level of medication adherence(12 months follow-up)
  • functioning(12 months follow-up)

研究者

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

Chien Wai-Tong

Professor

The Hong Kong Polytechnic University

研究点 (2)

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