Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/05/2005
Date assigned
26/05/2005
Last edited
02/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nuh.nhs.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes