Condition category
Not Applicable
Date applied
10/05/2009
Date assigned
29/06/2009
Last edited
23/02/2011
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

Dr Alison Pighills

ORCID ID

Contact details

Hillside Bridge Health Centre
4 Butler Street West
Bradford
BD3 0BS
United Kingdom
+44 (0)1274 777559
alison.pighills@bradford.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N&AHP/04/023

Study information

Scientific title

Environmental assessment and modification to prevent falls in older people: a randomised controlled single centre trial

Acronym

Study hypothesis

The null hypothesis was that there is no difference in outcome in people who receive occupational therapist-led environmental assessment aiming to reduce falls as compared to those who receive the same intervention from a trained assessor.

The aim of this study was to pilot a randomised controlled trial to develop and test the methods to be used in a large multi-centre randomised controlled trial (RCT), which would investigate the clinical effectiveness of environmental assessment and modification in the prevention of falls in older people. The research questions were:
1. What is the best RCT design to investigate the clinical effectiveness of environmental assessment and modification?
2. Does environmental assessment and modification reduce fear of falling, a surrogate outcome, and subsequent falls?
3. Is environmental assessment and modification more effective if professionally prescribed by an occupational therapist than if provided by a trained assessor?

Ethics approval

Airedale Research Ethics Committee gave approval on the 23rd September 2005 (ref: 05/Q1201/38)

Study design

Randomised controlled single centre 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

Intervention

Participants were randomised to one of three groups:
1. OT-led environmental assessment
2. Trained assessor-led environmental assessment
3. Usual care control

The Westmead Home Safety Assessment (WeHSA) was the primary focus of the intervention. A staff training programme was developed comprising of a workshop based on the content of the WeHSA manual. Thirteen occupational therapists and 13 non-professionally qualified staff who volunteered to deliver the trial intervention were trained. The environmental intervention was a one-off assessment of the participant's home environment. Following the assessment, potential falls hazards were discussed with the participant and recommendations made. The staff member carried out any action agreed. Assessment visits took between one and a half to two hours to conduct. A written summary of agreed recommendations was sent to the participant and a follow-up telephone contact was made after four weeks to check that the recommendations had been carried out.

The control group received usual care; receipt of falls prevention interventions during the 12 month follow up period was monitored and controlled for in the analysis.

Duration of intervention:
Intervention arms: One-off assessment with 12 months follow up for falls
Controls: Usual care with 12 months follow up for falls

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Falls Efficacy Scale - International version, measured at baseline, 3, 6 and 12 months

Secondary outcome measures

1. Falls, measured on a monthly basis for 12 months
2. Quality of life: 12-item short form health survey (SF-12) and EuroQol, measured at baseline, 3, 6 and 12 months
3. Activities of daily living - Barthel Index, measured at baseline, 3, 6 and 12 months

Overall trial start date

01/02/2006

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Community dwelling people aged 70 or over (either sex) with a history of falls in the previous year living in the catchment area of Airedale NHS Trust

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

227 participants

Participant exclusion criteria

1. Have received an environmental assessment from an occupational therapist in the previous year
2. Currently receiving occupational therapy (OT)
3. Living in nursing or residential homes

Recruitment start date

01/02/2006

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hillside Bridge Health Centre
Bradford
BD3 0BS
United Kingdom

Sponsor information

Organisation

University of York (UK) - York Trials Unit

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk

Sponsor type

Not defined

Website

http://www.york.ac.uk/healthsciences/centres/trials/abouttheunit.htm

Funders

Funder type

Government

Funder name

National Institutes of Health Research (NIHR) (UK) - Research Capacity Development Programme: Nursing and Allied Health Professions fellowship awards (ref: 05/Q1201/38)

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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21226674

Publication citations

  1. Results

    Pighills AC, Torgerson DJ, Sheldon TA, Drummond AE, Bland JM, Environmental assessment and modification to prevent falls in older people., J Am Geriatr Soc, 2011, 59, 1, 26-33, doi: 10.1111/j.1532-5415.2010.03221.x.

Additional files

Editorial Notes