Contact information
Type
Scientific
Primary contact
Prof Tahir Masud
ORCID ID
Contact details
Department of Rehabilitation and the Clinical Gerontology Research Unit
Nottingham City Hospital NHS Trust
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 969 1169 ext. 47193
tm@nchhce.demon.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol number 6.5, R&D reference 04ME03
Study information
Scientific title
Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial
Acronym
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?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
The proportion of older people who fall over one year, identified in primary care as being at high risk of falling
Secondary outcome measures
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
Overall trial start date
01/09/2004
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
400
Participant 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)
Recruitment start date
01/09/2004
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Rehabilitation and the Clinical Gerontology Research Unit
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Nottingham City Hospital (UK)
Sponsor details
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Nottinghamshire, Derbyshire and Lincolnshire Research Alliance (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research into Ageing/British Geriatrics Society (UK) - Dhole fellowship (ref: DF/04)
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
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16542012
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20833862
Publication citations
-
Protocol
Masud T, Coupland C, Drummond A, Gladman J, Kendrick D, Sach T, Harwood R, Kumar P, Morris R, Taylor R, Youde J, Conroy S, Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556]., Trials, 2006, 7, 5, doi: 10.1186/1745-6215-7-5.
-
Results
Irvine L, Conroy SP, Sach T, Gladman JR, Harwood RH, Kendrick D, Coupland C, Drummond A, Barton G, Masud T, Cost-effectiveness of a day hospital falls prevention programme for screened community-dwelling older people at high risk of falls., Age Ageing, 2010, 39, 6, 710-716, doi: 10.1093/ageing/afq108.