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ISRCTN
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ISRCTN03613183
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled Evaluation of Home treatment for Older People with Mental Illness
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0195177177
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Study hypothesis
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1. By means of a randomised controlled trial. We will evaluate the impact of home treatment of older individuals with severe mental illness on: A. bed occupancy and admission rates. B. satisfaction, Quality of life and Mental Health. C. Adverse outcomes. D. Mental Health and quality of life of carers.
2. By means of a cross-sectional survey using a semi-structured interview with purposive sampling, we will identify stakeholder views on the home treatment service with particular emphasis on: A. Problems with introduction of home treatment in this service. B. Issues of establishing home treatment to other services.
3. Using a combination of qualitative and quantitative data from (1) and (2) above, we will ascertain those elements of the treatment service that are judged to be of value from the perspective of service providers and consumers. The null Hypothesis for the study is that intensive home treatment of older people with mental illness confers no advantages in terms of outcome, satisfaction, quality of life or costs compared with usual care.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Mental illness
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Participants - inclusion criteria
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1. Age 65 and over living in North Kensington or Westminster
2. Able to give informed consent (or assent if unable to give real consent)
3. Adequate English to complete questionnaires
4. The participant meets the operational criteria for admission to the home treatment team which is mental illness/impairment or personality disorder with one or more of the following:
4.1 Risk of suicide/self harm, self neglect,harm to others and or loss of contact to the service
4.2.Non-adherence to therapy
4.3 Institution of new therapy
4.4 Stabilisation of mental state
4.5 Observation of mental state
4.6 Relief/respite for carers
4.7 Faciltate early discharge
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Participants - exclusion criteria
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Admission to continuing care or long term in-patient.
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Anticipated start date
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01/03/2005
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Anticipated end date
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28/02/2006
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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50 outpatients
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Interventions
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Participants will be recruited to the study at the point an admission is considered by the clinicians and randomised to home treatment as usual (2:1). Treatment will be for up to 8 weeks and participants will be evaluated at baseline, 8 weeks and 6 months.
Delivery of a multi-disciplinary intensive home treatment service versus usual care.
Added 21 August 2008: the trial was stopped in August 2005 due to very poor recruitment.
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Primary outcome measure(s)
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1. Administrative data, mental health, quality of life
2. Psychiatric hospital bed days
3. Proportion of patients admitted
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Secondary outcome measure(s)
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1. Quality of Life (EQ5D)
2. Functioning (Global Assessment Functioning Scale)
3. Partnerships in Care (Helping Alliances)
4. Poly pharmacy medication proforma
5. Service Utilisation (proforma)
6. Residency
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Sources of funding
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London West Mental Health R&D Consortium, CNWL Mental Health Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
James
Warner
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Address
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Psychiatry
Imperial College London, Charing Cross Campus
Claybrook Centre, St Dunstans Road
Hammersmith
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City/town
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London
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Zip/Postcode
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W6 8RP
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Country
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United Kingdom
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Tel
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+44 07970 849818
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Fax
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+44
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Email
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j.warner@imperial.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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05/10/2011
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Date ISRCTN assigned
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29/09/2006
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