Multifactorial day hospital intervention to reduce falls in high risk older people in primary care
| ISRCTN | ISRCTN46584556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46584556 |
| Protocol serial number | Protocol number 6.5, R&D reference 04ME03 |
| Sponsor | Nottingham City Hospital (UK) |
| Funders | Nottinghamshire, Derbyshire and Lincolnshire Research Alliance (UK), Research into Ageing/British Geriatrics Society (UK) - Dhole fellowship (ref: DF/04) |
- Submission date
- 09/05/2005
- Registration date
- 26/05/2005
- Last edited
- 02/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Tahir Masud
Scientific
Scientific
Department of Rehabilitation and the Clinical Gerontology Research Unit
Nottingham City Hospital NHS Trust
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 969 1169 ext. 47193 |
|---|---|
| tm@nchhce.demon.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial |
| Study objectives | 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? |
| Ethics approval(s) | Added 08/09/2009: COREC approval has been obtained from the Nottingham main REC and the relevant local RECs (reference: 04/Q2404/93). |
| Health condition(s) or problem(s) studied | Falls |
| Intervention | 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. |
| Intervention type | Other |
| 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 |
| Key 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 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Rehabilitation and the Clinical Gerontology Research Unit
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No | |
| Protocol article | protocol | 27/02/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
