Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Warner

ORCID ID

Contact details

Psychiatry
Imperial College London
Charing Cross Campus
Claybrook Centre
St Dunstans Road
Hammersmith
London
W6 8RP
United Kingdom
+44 07970 849818
j.warner@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0195177177

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Mental illness

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Administrative data, mental health, quality of life
2. Psychiatric hospital bed days
3. Proportion of patients admitted

Secondary outcome measures

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

Overall trial start date

01/03/2005

Overall trial end date

28/02/2006

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

50 outpatients

Participant exclusion criteria

Admission to continuing care or long term in-patient.

Recruitment start date

01/03/2005

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychiatry
London
W6 8RP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

London West Mental Health R&D Consortium, CNWL Mental Health Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes