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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN57116180 |
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Date of registration:
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23/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised controlled trial of a computerised clinical decision support system for the management of psychiatric disorder in primary care.
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Scientific title:
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Date of first enrolment:
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01/12/1996 |
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Target sample size:
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762 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN57116180 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Other)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Glyn
Lewis |
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Address:
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Psychological Medicine
University of Wales College of Medicine
Monmouth House
Heath Park
CF14 4XN
Cardiff
United Kingdom |
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Telephone:
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+44 (0)29 2074 4394 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Five general practices in Bristol and Cardiff participated in the study.
2. Eligible subjects were consecutive general practitioner (GP) attenders who were aged 16 years and over who completed the general health questionnaire (GHQ-12).
3. Subjects who had a positive GHQ score (i.e. >3) and who achieved a score of 12 or more on the CIS-R (Computerised Interview Schedule [Reduced]) were randomised.
Exclusion criteria: 1. A previous diagnosis of a psychotic illness
2. A mental handicap or cognitive impairment
3. Language or literacy difficulties
4. A severe or terminal physical illness
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia and other psychoses
Mental and Behavioural Disorders
Mental disorder, not otherwise specified
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Intervention(s)
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Cases of common mental disorder were identified by case-finding questionnaire and then randomly allocated within practices to
1. An intervention group, in which the GP was given the results of a detailed self-administered computerised psycho-social assessment, combined with patient-specific treatment recommendations, or
2. A control group, in which the GP was not given any additional information or advice, but who had access to a copy of locally agreed clinical practice guidelines.
Randomisation was performed by the computer which administered the questionnaires and generated the advice for the GP. The randomisation was therefore concealed from the research assistant and the subject.
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Primary Outcome(s)
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12-item General Health Questionnaire (GHQ12)
Outcome was assessed at 6 weeks and 6 months. The subjects were sent the questionnaires by post and were reminded by telephone if they did not respond.
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Secondary Outcome(s)
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1. Quality of life assessed with 6 questions
2. Satisfaction with treatment assessed with 1 question: If a friend were in need of similar help from a general practitioner would you recommend your GP to him/her?
3. Number of consultations in primary care assessed both by asking the subjects, and also by recording the number of consultations in the primary care notes of the subjects
4. In 2 of the practices we recorded the psychotropic medication prescriptions for all those in the trial.
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Source(s) of Monetary Support
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NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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