Condition category
Signs and Symptoms
Date applied
30/09/2009
Date assigned
29/10/2009
Last edited
30/10/2012
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

Dr Philippa Anne Logan

ORCID ID

Contact details

B99
Division of Rehabilitation and Ageing
Medical School
Queens Medical Centre Campus
Nottingham
NG7 2UH
United Kingdom
pip.logan@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

A randomised controlled trial to compare falls prevention rehabilitation for people who fall and call an emergency ambulance but who are not transported to hospital

Acronym

Study hypothesis

The hypothesis was that falls prevention rehabilitation would reduce the falls rate over 12 months compared to usual practice.

Ethics approval

North Nottinghamshire Local Research Ethic Committee and NHS R&D approval from Nottinghamshire Primary Care Trust granted on 19th July 2005 (ref: 05/Q2402/53)

Study design

Randomised two armed controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 prevention

Intervention

Intervention group: Community falls prevention rehabilitation and normal medical and social care
Control group: Normal medical and social care

Patients will be treated for 6 months and followed-up for 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rate of falls over 12 months measured using a falls diary

Secondary outcome measures

Measured at 6 and 12 months:
1. Number of falls
2. Independence in activities of daily living
3. Days to first fall
4. Fear of falling
5. Hospital admissions
6. Number of emergency ambulance calls

Overall trial start date

01/09/2005

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 60 years, either sex
2. Living at home or in care homes in four Nottinghamshire (UK) Primary Care Trusts (PCT)
3. Contacted the East Midlands Ambulance Service (EMAS) through the emergency telephone system because of a fall
4. Had not been transported to hospital

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Unable to give consent
2. Deemed too ill to participate (e.g. terminally ill)
3. Already in a falls prevention rehabilitation programme

Recruitment start date

01/09/2005

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

B99, Division of Rehabilitation and Ageing
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services (RIS)
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

College of Occupational Therapy (UK)

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20460331
2. 2012 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22695789

Publication citations

  1. Results

    Logan PA, Coupland CA, Gladman JR, Sahota O, Stoner-Hobbs V, Robertson K, Tomlinson V, Ward M, Sach T, Avery AJ, Community falls prevention for people who call an emergency ambulance after a fall: randomised controlled trial., BMJ, 2010, 340, c2102.

  2. Economic evaluation

    Sach TH, Logan PA, Coupland CA, Gladman JR, Sahota O, Stoner-Hobbs V, Robertson K, Tomlinson V, Ward M, Avery AJ, Community falls prevention for people who call an emergency ambulance after a fall: an economic evaluation alongside a randomised controlled trial., Age Ageing, 2012, 41, 5, 635-641, doi: 10.1093/ageing/afs071.

Additional files

Editorial Notes