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21 May 2012
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| [ Print-friendly version ] |
| Multifactorial day hospital intervention to reduce falls in high risk older people in primary care |
| ISRCTN | ISRCTN46584556 |
| ClinicalTrials.gov identifier | |
| Public title | Multifactorial day hospital intervention to reduce falls in high risk older people in primary care |
| Scientific title | Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial |
| Acronym | N/A |
| Serial number at source | Protocol number 6.5, R&D reference 04ME03 |
| Study hypothesis |
The main hypothesis to be tested is that a multidisciplinary falls assessment and intervention occurring at a Geriatric Day hospital can decrease the rate of falls over the course of one year, in older people identified in primary care as being at high risk of falling.
Secondary research questions: 1. Can the above intervention reduce the proportion of people with single or recurrent falls (greater than 1)? 2. Can the above intervention reduce fall-related injuries (including fractures)? 3. Can the above intervention reduce disability and improve quality of life? 4. Can the above intervention reduce institutionalisation and the need for the use of health services? 5. Is the intervention cost-effective and might it lead to overall cost-savings? 6. Can a screening questionnaire used in primary care reliably distinguish between low and high risk of falling? 7. Is there any difference in deaths between the two groups? |
| Lay summary | |
| Ethics approval | Added 08/09/2009: COREC approval has been obtained from the Nottingham main REC and the relevant local RECs (reference: 04/Q2404/93). |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Falls |
| Participants - inclusion criteria | The study population will comprise men and women aged 70 and over identified as being at high risk of falling by a postal screening questionnaire, registered with the participating general practices in Nottinghamshire and Derbyshire. |
| Participants - exclusion criteria |
1. Patients already attending one of the day hospitals
2. Patients under follow-up with an existing primary care based falls prevention scheme 3. Residents in nursing or residential homes 4. Patients with terminal illnesses 5. Those unwilling or unable to travel to the day hospital (using transport as provided) |
| Anticipated start date | 01/09/2004 |
| Anticipated end date | 31/05/2006 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 400 |
| Interventions |
Intervention arm:
Screening questionnaire, information leaflet, leaflet on falls prevention and invitation to attend the day hospital for assessment and any subsequent intervention. Control arm: Screening questionnaire, information leaflet, leaflet on falls prevention and usual care from primary care service until outcome data collected, then offer of day hospital intervention. |
| Primary outcome measure(s) | The proportion of older people who fall over one year, identified in primary care as being at high risk of falling |
| Secondary outcome measure(s) |
Added 08/09/2009:
1. Proportion of people with single or recurrent falls (greater than 1) 2. Fall-related injuries: fracture, serious sprain requiring immobilisation in plaster, joint dislocations, head injury requiring hospitalisation, and lacerations requiring suturing 3. Disability: Nottingham Extended Activities of Daily Living Scale; Barthel Index of Daily Living; Quality of life: Falls Efficacy Scale and EuroQoL-5 4. Institutionalisation and use of health services: residency and diary information 5. Cost analysis 6. Screening tool, defined by sensitivity/specificity as well as positive and negative predictive values 7. Deaths will be checked against PCT records and measured as proportions |
| Sources of funding |
1. Nottinghamshire, Derbyshire and Lincolnshire Research Alliance (UK)
2. Research into Ageing/British Geriatrics Society (UK) - Dhole fellowship (ref: DF/04) |
| Trial website | |
| Publications |
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16542012
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20833862 |
| Contact name | Prof Tahir Masud |
| Address |
Department of Rehabilitation and the Clinical Gerontology Research Unit
Nottingham City Hospital NHS Trust |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Tel | +44 (0)115 969 1169 ext. 47193 |
| Fax | +44 (0)115 962 7788 |
| tm@nchhce.demon.co.uk | |
| Sponsor | Nottingham City Hospital (UK) |
| Address | Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Sponsor website: | http://www.nuh.nhs.uk/ |
| Date applied | 09/05/2005 |
| Last edited | 02/02/2011 |
| Date ISRCTN assigned | 26/05/2005 |
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