Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/06/2016
Date assigned
21/06/2016
Last edited
06/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Falls are common in older people and can cause serious health problems. Most falls happen when people are at home. Hazards in the home, such as slippery floors or poor lighting, are important causes. A review of the current research looked at the effect that home visits by an occupational therapist had on falls. This research involved people who had been treated in hospital for a fall. During the visit the occupational therapist would look at potential hazards that could lead to falls in the home and suggest changes to try to avoid them happening. This review of research found people who were visited by an occupational therapist had fewer falls. Some members of our research team did a small study and found that people in the community who had not been admitted to hospital because of a fall, also had fewer falls when visited by an occupational therapist. To be more confident of these results, we wish to conduct a larger study to find out if people in the community would have fewer falls if they have a home hazard assessment by an occupational therapist. We also want to find out if this would be good value for money for the NHS.

Who can participate?
People aged 65 and over who are at an increased risk of falling (i.e., who have either have had at least one fall in the past 12 months or tell us that they worry about falling in their day-to-day lives).

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives usual care from their GP or other healthcare professional and a falls prevention leaflet. In addition to usual care and a falls prevention leaflet, the other group receives a home environmental assessment by an occupational therapist to assess their home for dangers and make recommendations for changes. Four weeks later the therapist rings them to find out if the recommendations made have been followed. Participants are asked, by filling in monthly falls calendars and postal questionnaires, if they’ve had a fall, about their quality of life and how often they use NHS services.

What are the possible benefits and risks of participating?
We cannot promise that taking part in the study will help participants personally. However, it may help us find out how to reduce the number of falls older people have. We are not aware of any known risks to participants as the aim of the intervention being tested is to reduce falls.

Where is the study run from?
University of York, Department of Health Sciences, York Trials Unit (UK)

When is the study starting and how long is it expected to run for?
June 2016 to November 2018

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Sarah Cockayne
sarah.cockayne@york.ac.uk

Trial website

http://www.york.ac.uk/healthsciences/research/trials/research/trials/otis/

Contact information

Type

Scientific

Primary contact

Mrs Sarah Cockayne

ORCID ID

http://orcid.org/0000-0002-1288-5497

Contact details

University of York
Department Health Sciences
York Trials Unit
ARRC Building Lower Ground Floor
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321736
sarah.cockayne@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 14/49/149; 1.0

Study information

Scientific title

Does occupational therapist led home environmental assessment and modification reduce falls among high-risk older people?

Acronym

OTIS

Study hypothesis

Main OTIS trial hypothesis: The null hypothesis is that there is no difference in the number of falls people over the age of 65 years who are of high risk of falling, have in the 12 months post randomisation between the two trial groups. The intervention group will receive an occupational therapist led home environmental assessment and modification, and a falls prevention leaflet. The control group will receive the falls prevention leaflet and usual care from their GP and/or other healthcare professionals.

Pen sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants allocated to receive a pen with their trial invitation pack who go on to be randomised to the main OTIS trial, than in the group who do not receive a pen.

Text sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants returning their 4-month questionnaire between the group that receive a personalised text message when their questionnaire is due and those that receive a standard text message.

Ethics approval

1. West of Scotland REC 3 committee, 08/08/2016, ref: 16/WS/0154
2. University of York, Department of Health Sciences Research Governance Committee, 20/05/2016

Study design

Multicentre open randomised controlled trial with an embedded qualitative study, economic evaluation and two studies within a trial (SWATs)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Falls prevention

Intervention

Main OTIS trial: Participants will be randomly allocated 2:1 in favour of the control group to either:
1. Usual care from their GP or other healthcare professional and a falls prevention leaflet
2. In addition to usual care and a falls prevention leaflet, the intervention group will receive one home environmental assessment and modification to identify personal fall related hazards by an occupational therapist.

Pen sub-study: Participants will be randomised in a 2:1 ratio in favour of the control group to receive either no pen or to receive a pen with their trial invitation pack.

Text sub-study: Trial participants will be randomised in a 1:1 ratio to receive either a personalised text or a standard text from the York Trials Unit at the time their four month follow-up questionnaire is due to be received.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Main OTIS trial: Number of falls experienced in the 12 months following randomisation, where a fall is defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level”, as collected prospectively via participant-reported monthly falls calendars.

Pen sub-study: The proportion of participants sent a trial invitation pack who go on to be randomised into the main OTIS trial.

Text sub-study: The proportion of four-month questionnaires returned to the York Trials Unit.

Secondary outcome measures

Main OTIS trial:
1. Health-related Quality of Life as measured by the EQ5D-5L at 4, 8 and 12 months
2. Proportion of participants reporting at least one fall in the 12 months from randomisation
3. Proportion of participants reporting multiple (2 or more) falls in the 12 months from randomisation
4. Time to first fall from date of randomisation, with censoring at date of withdrawal, death or end of 12 month follow-up
5. Fear of falling at 4, 8 and 12 months
6. Fall-related injuries and costs over the 12 months post randomisation
7. Patient self-reported fractures over the 12 months post randomisation

Pen sub-study:
1. Proportion of patients retained in the trial at 3 months post randomisation defined as returning at least the first 3 months’ worth of falls calendars from the date of randomisation
2. Number of ineligible participants

Text sub-study:
1. Time to response i.e. number of days between the questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit
2. The proportion of participants requiring a reminder
3. Completeness of questionnaires
4. Cost effectiveness of the text message intervention

Overall trial start date

01/06/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Main OTIS study:
1. Aged 65 years and over
2. Willing to receive a home visit from an Occupational Therapist
3. Community dwelling
4. Have at least one risk factor for a fall in the next 12 months i.e., either one fall in the past 12 months or report a fear of falling on their screening questionnaire or be a former REFORM trial participant

OTIS qualitative study: Occupational Therapists delivering the OTIS intervention, clinical leads who run falls prevention services/care of older people services and services external to the trial.

Pen sub-study: Any patient identified in the GP mail out as eligible to receive an OTIS trial invitation pack will be entered into the pen sub-study.

Text sub-study: Participants who provide a mobile phone number and consent to be contacted by this method, and who are due to be sent their four month follow-up questionnaire will be included in this sub-study.

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

Main OTIS trial: 1299 (n=433 Intervention group; n=866 Usual Care group); OTIS qualitative study n=30; SWATs: no formal sample size calculation undertaken

Participant exclusion criteria

Main OTIS trial:
1. Unable to walk 10 feet today, with a walking aid if needed
2. Unable to give informed consent e.g., due to suffering from dementia or Alzheimer’s disease
3. Living in residential or nursing home
4. Do not speak English
5. Had a home assessment in the previous 12 months as a result of falling
6. Are on a waiting list for an occupation therapy assessment
7. Have not completed one falls calendar in the 3 months prior to randomisation

Pen sub-study: Participants in the REFORM, CASPER and Yorkshire Health Study cohorts and the SCOOP study will be excluded from the sub-study.

Text sub-study: Participants who withdraw from the OTIS main trial follow-up before their 4-month questionnaire is due will be excluded from the mail out.

Recruitment start date

01/08/2016

Recruitment end date

31/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
S10 2JF
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

Contracts and Sponsorship Manager
Research and Enterprise
University of York
Innovation Centre
York Science Park
York
YO10 5DG
United Kingdom
+44 (0)1904 435154
michael.barber@york.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The main trial results and study protocol will form the basis of academic papers in peer-reviewed journals.
The outcomes of the trial will be presented as a conference paper on completion of the trial.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes