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临床试验/NCT00283270
NCT00283270已完成4 期

A Randomised Controlled Trial on the Effectiveness of Screening and Brief Counselling for Elderly Patients With Psychological Problems in Primary Care.

The University of Hong Kong0 个研究点目标入组 450 人开始时间: 2002年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
450
主要终点
Health-related quality of life scores

研究概览

简要总结

The aim of the study is to test whether screening followed by brief problem-solving counselling in primary care could improve the quality of life of elderly patients with undiagnosed psychological problems. We hypothesize that undiagnosed psychological problems detectable by screening are common in the elderly and brief counselling could improve the quality of life of these patients.

详细描述

Objectives: The aim of the study is to test if screening followed by brief problem-solving counselling by primary care doctors can improve the health-related quality of life (HRQOL) of elderly patients with previously undiagnosed psychological problems. It will also find out the effects of undiagnosed psychological problems on HRQOL and consultation rates of elderly patients.

Design, Setting & Subjects: This is a prospective single-blinded randomised controlled trial on 450 patients aged 60 or above attending a Government General Outpatient Clinic in Hong Kong, who have been screened for psychological problems.

Methods: Elderly patients attending the General Outpatient Department of the Ap Lei Chau Clinic who are not known to have the diagnosis of psychological problems with the Hospital Anxiety & Depression Scale (HADS) were screened in order to recruit 300 subjects who are screened positive for undiagnosed psychological problems will be randomised into the counselling or no-counselling groups, and 150 subjects who are screened negative for psychological problems will be selected as normal controls

Interventions: The counselling group will receive brief problem-solving counselling from a trained primary care doctor in addition to their usual medical care; the no-counselling group will receive general health education and their usual medical care; and the normal control group will continue with their usual care only.

Main Outcome Measures: Health-related quality of life measured by the SF-36, the HADS scores and consultation rates. The baseline and changes in outcomes of the three groups will be compared at 0, 6, 12, 36 and 52 weeks after screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 60 or above
  • Attending the study primary care clinic
  • No known diagnosis of psychological problem
  • Written consent provided

排除标准

  • Known psychological disease diagnosed by a registered practitioner
  • Taking any psychotropic drug prescribed by a registered practitioner of Western medicine within the last year;
  • Has suicidal plan or strong suicidal thought;
  • Has psychotic symptom;
  • any impairment in cognitive function; or
  • any communication problem
  • refuses to participate

结局指标

主要结局

Health-related quality of life scores

Hospital Anxiety and Depresssion scores

次要结局

  • Consultation rates

研究者

申办方类型
Other

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