Randomised controlled Evaluation of Home treatment for Older People with Mental Illness
| ISRCTN | ISRCTN03613183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03613183 |
| Secondary identifying numbers | N0195177177 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 05/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr James Warner
Scientific
Scientific
Psychiatry
Imperial College London, Charing Cross Campus
Claybrook Centre, St Dunstans Road
Hammersmith
London
W6 8RP
United Kingdom
| Phone | +44 07970 849818 |
|---|---|
| j.warner@imperial.ac.uk |
Study information
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2005 |
| Completion date | 28/02/2006 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 50 outpatients |
| Key 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 |
| Key exclusion criteria | Admission to continuing care or long term in-patient. |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychiatry
London
W6 8RP
United Kingdom
W6 8RP
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
London West Mental Health R&D Consortium, CNWL Mental Health Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
