Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People

NCT04717258 | Terminated Results DMC

• 1 other identifier: FIREFLI Trial Protocol v6.0
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

FIREFLI is a large, pragmatic, individually randomised, controlled trial with embedded economic and qualitative evaluations. The aim of the research is to see whether Safe and Well Visits delivered by the Fire and Rescue Service will lead to a reduction in the number of falls and an improvement in health-related quality of life in older people. It will also look at the cost-effectiveness of the intervention and explore the acceptability of the Safe and Well Visits to older people and the Fire and Rescue Service. The investigators will recruit 1156 participants, randomly divided into two equal groups. One group (the intervention group) will receive the Safe and Well Visit at the beginning of the study and the other group (the control group) will receive the visit at the end of the study. The investigators will collect the number of falls people have using monthly falls calendars and follow up other outcomes by questionnaires at four, eight and 12 months post-randomisation. The investigators will also undertake interviews with some participants and with Fire and Rescue Service staff to explore experiences around the Safe and Well Visits. Two Studies within a Trial (SWAT) will be carried out to investigate more efficient ways of running trials. The first will test if using a recruitment invitation letter informed by Self-Determination Theory will increase the number of participants who take part in the study. The second will test if including a pen with the reminder four-month questionnaire will increase the number of postal questionnaires returned to the study team.

Conditions

Accidental Fall; Quality of Life; Aged

Outcome Measures

Primary Outcomes (5)

• Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.

  The number of self-reported falls per participant over the 12 months from randomisation. A fall is defined as an unexpected event in which the participant comes to rest on the ground, floor, or lower level". Data will be collected prospectively via participant-reported monthly falls calendars.

  Falls per participant over the 12 months from randomisation.

• Health-related Quality of Life Measured by the EuroQol 5 Dimensions, 5 Level Version

  Health-related self reported quality of life measured by the EuroQol 5 Dimensions. It measures health (functioning) in terms of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity. The EQ5D-5L will be used to calculate a EQ-5D-5L utility index score. A utility index score of one represents full health and a score of zero represents death, with it also being possible to have states worse than death as indicated by negative scores. A score of 1 is the best health and -0.574 the worst.

  Over the 12 months from randomisation.

• Recruitment SWAT: Recruitment to the FIREFLI Trial.

  The proportion of participants randomised into the main FIREFLI trial calculated as the number of participants randomised to the main FIREFLI trial divided by the total number of recruitment packs mailed out to potential participants.

  End of recruitment - approximately one year.

• Retention SWAT: Four-month Questionnaire Response Rate.

  The proportion of four-month reminder questionnaires returned to the York Trials Unit (YTU) calculated as the number of returned four-month follow-up questionnaires divided by the total number of four-month questionnaires mailed out to participants.

  Four months from randomisation.

• The EuroQol-5D Visual Analogue Scale

  The EuroQol-5D Visual Analog Scale (VAS) score is a patient self-reported validated instrument. It consists of a vertical VAS with values between 0 (worst imaginable health) and 100 (best imaginable health), on which participants provide a global assessment of their health. Higher score indicate better health state.

  Over 12 months since randomisation

Secondary Outcomes (17)

• Time to First Fall and Between Subsequent Falls.

  Over the 12 months from randomisation.

• Proportion of Participants Reporting at Least One Fall.

  Over the 12 months from randomisation.

• Proportion of Participants Reporting Two or More Falls.

  Over the 12 months from randomisation.

• Fear of Falling

  At four, eight and 12 months post-randomisation measured by asking participants to score how often they have worried about having a fall in the past four weeks.

• Universtiy of California Los Angeles (UCLA) 3-item Loneliness Scale

  At four, eight and 12 months post-randomisation.

Study Arms (6)

Main FIREFLI trial: Intervention arm

EXPERIMENTAL

Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) offered by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer) once randomised.

Other: Fire and Rescue Service Safe and Well Visit

Main FIREFLI trial: Control arm

NO INTERVENTION

Usual care from healthcare professionals; falls prevention leaflet; Safe and Well Visits (SWVs) by the Fire and Rescue Service (FRS) (either a firefighter, day duty safety advocate or home safety officer offered 12 months post-randomisation)

Recruitment SWAT: Self-Determination Theory informed invitation letter

EXPERIMENTAL

The recruitment pack to take part in the FIREFLI study will include an invitation letter informed by Self-Determination Theory.

Other: Self-Determination Theory informed trial invitation letter

Recruitment SWAT: Standard invitation letter

NO INTERVENTION

The recruitment pack to take part in the FIREFLI study will include the University of York, York Trials Unit's standard invitation letter

Retention SWAT: Pen arm

EXPERIMENTAL

A pen (which has the University of York logo on it) will be included with the first four-month reminder questionnaire.

Other: Pen included with reminder questionaire

Retention SWAT: No pen

NO INTERVENTION

No pen will be included with the four-month reminder questionnaire.

Interventions

Fire and Rescue Service Safe and Well Visit OTHER

Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population

Main FIREFLI trial: Intervention arm

Self-Determination Theory informed trial invitation letter OTHER

Invitation letter to take part in the FIREFLI study informed by Self-Determination Theory

Recruitment SWAT: Self-Determination Theory informed invitation letter

Pen included with reminder questionaire OTHER

A pen will be included with the four-month reminder questionnaire.

Retention SWAT: Pen arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women aged 65 years and over in the Humberside FRS area or aged 79 and over in the Kent Fire and Rescue Service (FRS) area
• Community dwelling
• Willing to receive a SWV from the FRS

You may not qualify if:

• Living in a residential or nursing home
• Bed bound
• Unable to give informed consent to take part in the study and living alone
• Had an occupational therapist (OT) visit within the past 12 months
• Received a SWV from the FRS in the past three years
• Have been referred to the FRS as an urgent referral
• Recruitment Study within a trial (SWAT)

Sponsors & Collaborators

• Caroline Fairhurst: lead
• Humberside Fire and Rescue Service: collaborator
• Leicestershire Partnership NHS Trust: collaborator
• University of Nottingham: collaborator
• Kent Fire and Rescue Service: collaborator
• James Cook University, Queensland, Australia: collaborator
• Queensland Health: collaborator

Study Sites (2)

Humberside Fire and Rescue Service

Hull, East Yorkshire, HU4 7BB, United Kingdom

Location

Kent Fire and Rescue Service

Maidstone, Kent, ME15 6XB, United Kingdom

Location

Related Publications (3)

• Cockayne S, Fairhurst C, Cunningham-Burley R, Mann J, Stanford-Beale R, Hampton S, Wilkinson S, Adamson J, Crossland S, Drummond A, Hewitt CE, Pighills A, Roberts G, Ronaldson S, Scantlebury A, Torgerson DJ; FIREFLI team. Effectiveness of Safe and Well Visits in reducing falls and improving quality of life among older people: The FIREFLI RCT. Public Health Res (Southampt). 2025 Sep;13(7):1-62. doi: 10.3310/DJHF6633.

  PMID: 41013989 DERIVED

• Adamson J, Scantlebury A, Drummond A, Fairhurst C, Cockayne S; Firefli team. Why do common sense trials fail in the UK? Lessons learned from a trial which tested the effectiveness and cost-effectiveness of a community falls prevention programme (the Firefli study). Trials. 2025 Sep 26;26(1):365. doi: 10.1186/s13063-025-09116-x.

  PMID: 41013512 DERIVED

• Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  PMID: 39360568 DERIVED

Related Links

• National Institute of Health Research (NIHR)
• York Trials Unit, University of York, United Kingdom

MeSH Terms

Interventions

Fires

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health

Results Point of Contact

• Title: Sarah Cockaiyne
• Organization: University of York

sarah.cockayne@york.ac.uk

01904321736

Study Officials

• Sarah Cockayne

  University of York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior statistician

Model Details: This study consists of a two-arm main trial, with two embedded two-arm SWATs.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 22, 2021
• Study Start: January 6, 2022
• Primary Completion: January 31, 2023
• Study Completion: July 10, 2023
• Last Updated: June 4, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)