Accidental FallFIREFLINCT04717258
Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People
A study testing Fire and Rescue Service Safe and Well Visit, Self-Determination Theory informed trial invitation letter and Pen included with reminder questionaire in people with Accidental Fall and Quality of Life, run by Caroline Fairhurst at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Fall, Quality of Life, Aged
- What is being tested?
- Fire and Rescue Service Safe and Well Visit, Self-Determination Theory informed trial invitation letter and Pen included with reminder questionaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Jan 2022to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- For those participants who have been sent a recruitment pack directly from York Trials Unit (YTU) in response to advertising or hearing about the study, as opposed to receiving an invitation and recruitment pack via the mail out from the FRS, a further eligibility check is required to see if the participant is eligible for a Safe and Well Visit by the FRS. In these circumstances, there is another exclusion criterion: Not eligible for a Safe and Well Visit with the FRS.
- Recruitment Study within a trial (SWAT)
- Inclusion criteria Any patient identified by the Fire and Rescue Service as eligible to receive a FIREFLI trial invitation pack.
- Retention SWAT Inclusion criteria For logistical reasons, all participants due to be sent a four month questionnaire will be randomised into the SWAT. However, only those sent a four month questionnaire reminder letter will be included in the analysis.
- Exclusion criteria Participants who withdraw from follow-up before their four month questionnaire is due and those for whom it is not necessary to send a reminder letter will be excluded from the SWAT.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Humberside Fire and Rescue Service
Hull, East Yorkshire, HU4 7BB
Kent Fire and Rescue Service
Maidstone, Kent, ME15 6XB
About this study
Official title: Do Safe and Well Visits Delivered by the Fire and Rescue Service Reduce Falls and Improve Quality of Life Among Older People? A Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
The Fire and Rescue Services routinely carry out around 670,000 fire safety check visits in England each year in people's homes. The aim of these 'Safe and Well Visits' is to reduce fire risks, support independent living, improve quality of life, and help prevent avoidable hospital admissions and excess winter deaths.
One part of the Safe and Well Visit is looking at ways to prevent falls. For some people, falling can cause serious health issues and in some cases may be fatal. About a third of people over the age of 65, and half of those over 80, will fall each year. Many of these falls happen at home. Falling may cause people to lose confidence, feel as if they have lost their independence and become withdrawn. About a fifth of all of the falls people have need medical attention. There were around 210,000 people admitted to hospital, as an emergency, in England in 2016 due to having had a fall. It costs the National Health Service (NHS) about £2.3 billion a year to treat patients who fall. The problem is likely to get worse as people are living longer. What investigators do not know is whether Safe and Well Visits undertaken by members of the Fire and Rescue Service reduce falls and can improve health-related quality of life and if they are good value for money.
To find out if Safe and Well Visits reduce the number of falls older people have and improve their quality of life, investigators will conduct a trial. The investigators will recruit 1156 people aged 70 years and over from lists of people held on Fire and Rescue Service databases or by advertising for participants and allocate half of the people to receive a Safe and Well Visit at the start of the study. The visit will last about an hour and will be tailored to the risks of the people living in the household. The other half of the people will receive the Safe and Well Visit after 12 months (when they have finished the study). Everyone will receive a falls prevention leaflet from Age United Kingdom and their usual care from their General Practitioner and other health care professionals. Participants will be asked to fill in monthly falls calendars and three postal questionnaires over 12 months to collect information about falls, their quality of life, how often they have used NHS services, and whether they are doing any activities that make them more likely to have a fire in their home. This information may be collected over the phone or investigators may send questionnaires in the post. Researchers will analyse the data to find out if the Safe and Well Visits reduce falls and if they are good value for money. The investigators also want to find out if the Safe and Well Visits are acceptable to older people and to the Fire and Rescue Service. This will be explored through a series of in-depth interviews. The investigators will assess treatment fidelity using the following strategies: observations of those delivering the Safe and Well Visits; delivery inventory will be completed for each participant; participant outcome questionnaires will include information on adherence with the intervention; and interviews with trial participants and members of the Fire and Rescue Service who delivered the Safe and Well Visits.
In addition to the main FIREFLI study investigators will undertake two additional trial methodological Studies within a Trial (SWAT) to evaluate one recruitment and one retention strategy. 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.
Once the trial is completed, the investigators will make sure the results can be used by as many people as possible. They will send the people who took part in the study a summary of the findings, and the results will be presented at relevant conferences and published in scientific journals. Investigators will share these findings with other Fire and Rescue Services.
- Conditions
- Accidental Fall, Quality of Life, Aged
- Being tested
- Fire and Rescue Service Safe and Well Visit, Self-Determination Theory informed trial invitation letter, Pen included with reminder questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fire and Rescue Service Safe and Well VisitOther
Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population
Self-Determination Theory informed trial invitation letterOther
Invitation letter to take part in the FIREFLI study informed by Self-Determination Theory
Pen included with reminder questionaireOther
A pen will be included with the four-month reminder questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Pen included with reminder questionaire |
| Retention SWAT: No pen | No intervention | No pen will be included with the four-month reminder questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 12 months since randomisation
Secondary outcomes (17)
Time to First Fall and Between Subsequent Falls.
Time to each fall, with censoring at date of withdrawal, death or end of 12 month follow-up measured using fall data from monthly falls calendars or follow-up questionnaires. The time to the first fall will be derived as the number of days from randomisation until the patient reports having a fall. Time in days between any subsequent falls will also be calculated.
Measured: Over the 12 months from randomisation.
Proportion of Participants Reporting at Least One Fall.
Proportion of participants reporting at least one fall in the 12 months from randomisation calculated as the number who report at least one fall on their monthly falls calendars or participant follow-up questionnaires divided by the total number of randomised participants.
Measured: Over the 12 months from randomisation.
Proportion of Participants Reporting Two or More Falls.
Proportion of participants reporting at least two falls in the 12 months from randomisation calculated as the number who report at least one fall on their monthly falls calendars or participant follow-up questionnaires divided by the total number of randomised participants.
Measured: Over the 12 months from randomisation.
Fear of Falling
Participants will be asked to score how often they have worried about falling in the past four weeks. Six response categories will be used (all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time). This will be scored from a minimum of 1 to a maximum of 6 respectively and treated as continuous data. Minimum score is 1 and maximum score is 6, with higher scores indicating less concern about falling.
Measured: 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
The UCLA 3-item loneliness scale is a screening tool for loneliness in adults. The scale consists of three questions that measure three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. Each question is rated on a 3-point scale ('hardly ever' = 1 point, 'some of the time' = 2 points, 'often' = 3 points). The scores for each individual question are added together to give a possible range of scores from 3 to 9. A higher scores indicates a higher degrees of loneliness.
Measured: At four, eight and 12 months post-randomisation.
Fall Related Injuries and Costs.
Fall-related injuries and costs over the 12 months from randomisation measured using participant self-reported data from follow-up questionnaires at four, eight and 12 months post-randomisation. The following data will be collected: injuries, healthcare resource use in primary care and community (i.e. General Practitioner, occupational therapist and physiotherapist) and secondary care (i.e. inpatient nights in hospital, day case attendances, outpatient attendances, and accident and emergency). Data on participant's time and expenses (i.e. travel costs and additional equipment) and informal care provided by friends/family, including productivity losses, will also be collected.
Measured: At four, eight and 12 months post-randomisation.
Fire Risk Taking Behaviours
Fire risk taking behaviours measured using participant self-report.
Measured: At four, eight and 12 months post-randomisation.
Uptake of Flu Jab
Uptake of flu jab using participant self-reported flu vaccination within the past 12 months.
Measured: Over the 12 months from randomisation.
Smoking/Vaping Status of Residents Within the Property
Smoking/vaping status of residents within the property, smoking or vaping inside the property, smoking in bed, and referral to National Health Service stop smoking services at four, eight and 12 months measured using participant self-reported data from follow-up questionnaires at four, eight and 12 months.
Measured: At four, eight and 12 months post-randomisation.
Participant Reported Fire Within the Property That the FRS Attended at Four, Eight and 12 Months Post-randomisation.
Participant reported fire within the property that the FRS attended at four, eight and 12 months post-randomisation
Measured: At four, eight and 12 months post-randomisation.
Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.
Fire incident.
Measured: At four, eight and 12 months post-randomisation.
Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.
Fire incident.
Measured: At four, eight and 12 months post-randomisation..
Recruitment SWAT: Proportion of Participants Who Return a Screening Form
Proportion of participants who return a screening form calculated as the number of participant-completed screening forms returned to YTU divided by the number of screening forms posted out to potential participants.
Measured: Enrollment
Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation
Proportion of participants who are eligible for randomisation calculated as the number of participants assessed as eligible for randomisation by researchers at YTU divided by the number of screening forms posted out to potential participants.
Measured: Enrollment
Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation
Proportion of participants who remain in the trial at three months post-randomisation calculated as the number of participants who return at least the first three months' worth of falls calendars from the date of randomisation, divided by the number of screening forms posted out to potential participants. This will also be calculated as a proportion of randomised participants.
Measured: Three months post-randomisation.
Retention SWAT: Time to Response
Time to response calculated as the number of days between the four-month questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit measured using the date the four-month questionnaire was mailed out and received back at YTU.
Measured: Four months post-randomisation.
Retention SWAT: Completeness of Response
The number of completed questions on the four month questionnaire.
Measured: Four months post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start6 Jan 2022
- Primary completion31 Jan 2023
- Study completion10 Jul 2023
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of a two-arm main trial, with two embedded two-arm SWATs.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Fairhurst
- Sponsor type
- University, hospital or other
- Collaborators
- Humberside Fire and Rescue Service, Leicestershire Partnership NHS Trust, University of Nottingham, Kent Fire and Rescue Service, James Cook University, Queensland, Australia, Queensland Health
- Responsible party
- Sponsor-investigator, Caroline Fairhurst, University of York
- Investigators
- Sarah Cockayne, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717258
- Sponsor's protocol ID
- FIREFLI Trial Protocol v6.0
- Acronym
- FIREFLI
- Status last verified
- Jun 2025
- First submitted
- 9 Dec 2020
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data and resources to be shared with researchers upon request. Please contact at given details.
Publications
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.
PubMed 41013989Adamson 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.
PubMed 41013512Drahota 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.
PubMed 39360568
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Safe and Well Visits Delivered by the Fire and Rescue Service Reduce Falls and Improve Quality of Life Among Older People? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04717258
- Acronym / sponsor ID
- FIREFLI / FIREFLI Trial Protocol v6.0
- Conditions
- Accidental Fall, Quality of Life, Aged
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Caroline FairhurstUniversity, hospital or other
- Collaborators
- Humberside Fire and Rescue Service, Leicestershire Partnership NHS Trust, University of Nottingham, Kent Fire and Rescue Service, James Cook University, Queensland, Australia, Queensland Health
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Fire and Rescue Services routinely carry out around 670,000 fire safety check visits in England each year in people's homes. The aim of these 'Safe and Well Visits' is to reduce fire risks, support independent living, improve quality of life, and help prevent avoidable hospital admissions and excess winter deaths.
One part of the Safe and Well Visit is looking at ways to prevent falls. For some people, falling can cause serious health issues and in some cases may be fatal. About a third of people over the age of 65, and half of those over 80, will fall each year. Many of these falls happen at home. Falling may cause people to lose confidence, feel as if they have lost their independence and become withdrawn. About a fifth of all of the falls people have need medical attention. There were around 210,000 people admitted to hospital, as an emergency, in England in 2016 due to having had a fall. It costs the National Health Service (NHS) about £2.3 billion a year to treat patients who fall. The problem is likely to get worse as people are living longer. What investigators do not know is whether Safe and Well Visits undertaken by members of the Fire and Rescue Service reduce falls and can improve health-related quality of life and if they are good value for money.
To find out if Safe and Well Visits reduce the number of falls older people have and improve their quality of life, investigators will conduct a trial. The investigators will recruit 1156 people aged 70 years and over from lists of people held on Fire and Rescue Service databases or by advertising for participants and allocate half of the people to receive a Safe and Well Visit at the start of the study. The visit will last about an hour and will be tailored to the risks of the people living in the household. The other half of the people will receive the Safe and Well Visit after 12 months (when they have finished the study). Everyone will receive a falls prevention leaflet from Age United Kingdom and their usual care from their General Practitioner and other health care professionals. Participants will be asked to fill in monthly falls calendars and three postal questionnaires over 12 months to collect information about falls, their quality of life, how often they have used NHS services, and whether they are doing any activities that make them more likely to have a fire in their home. This information may be collected over the phone or investigators may send questionnaires in the post. Researchers will analyse the data to find out if the Safe and Well Visits reduce falls and if they are good value for money. The investigators also want to find out if the Safe and Well Visits are acceptable to older people and to the Fire and Rescue Service. This will be explored through a series of in-depth interviews. The investigators will assess treatment fidelity using the following strategies: observations of those delivering the Safe and Well Visits; delivery inventory will be completed for each participant; participant outcome questionnaires will include information on adherence with the intervention; and interviews with trial participants and members of the Fire and Rescue Service who delivered the Safe and Well Visits.
In addition to the main FIREFLI study investigators will undertake two additional trial methodological Studies within a Trial (SWAT) to evaluate one recruitment and one retention strategy. 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.
Once the trial is completed, the investigators will make sure the results can be used by as many people as possible. They will send the people who took part in the study a summary of the findings, and the results will be presented at relevant conferences and published in scientific journals. Investigators will share these findings with other Fire and Rescue Services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study consists of a two-arm main trial, with two embedded two-arm SWATs.
| Arm | Type | Receives |
|---|---|---|
| Main FIREFLI trial: Intervention arm | Experimental | Other: Fire and Rescue Service Safe and Well VisitUsual 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. |
| 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 | Other: Self-Determination Theory informed trial invitation letterThe recruitment pack to take part in the FIREFLI study will include an invitation letter informed by Self-Determination Theory. |
| 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 | Other: Pen included with reminder questionaireA pen (which has the University of York logo on it) will be included with the first four-month reminder questionnaire. |
| Retention SWAT: No pen | No intervention | –No pen will be included with the four-month reminder questionnaire. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fire and Rescue Service Safe and Well VisitSafe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population | Other | Main FIREFLI trial: Intervention arm |
| Self-Determination Theory informed trial invitation letterInvitation letter to take part in the FIREFLI study informed by Self-Determination Theory | Other | Recruitment SWAT: Self-Determination Theory informed invitation letter |
| Pen included with reminder questionaireA pen will be included with the four-month reminder questionnaire. | Other | Retention SWAT: Pen arm |
Primary outcome
Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.
Time frame: 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.
Health-related Quality of Life Measured by the EuroQol 5 Dimensions, 5 Level Version
Time frame: Over the 12 months from randomisation.
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.
Recruitment SWAT: Recruitment to the FIREFLI Trial.
Time frame: End of recruitment - approximately one year.
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.
Retention SWAT: Four-month Questionnaire Response Rate.
Time frame: Four months from randomisation.
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.
The EuroQol-5D Visual Analogue Scale
Time frame: Over 12 months since randomisation
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.
17 secondary outcomes
Time to First Fall and Between Subsequent Falls.
Time frame: Over the 12 months from randomisation.
Proportion of Participants Reporting at Least One Fall.
Time frame: Over the 12 months from randomisation.
Proportion of Participants Reporting Two or More Falls.
Time frame: Over the 12 months from randomisation.
Fear of Falling
Time frame: 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
Time frame: At four, eight and 12 months post-randomisation.
Fall Related Injuries and Costs.
Time frame: At four, eight and 12 months post-randomisation.
Fire Risk Taking Behaviours
Time frame: At four, eight and 12 months post-randomisation.
Uptake of Flu Jab
Time frame: Over the 12 months from randomisation.
Smoking/Vaping Status of Residents Within the Property
Time frame: At four, eight and 12 months post-randomisation.
Participant Reported Fire Within the Property That the FRS Attended at Four, Eight and 12 Months Post-randomisation.
Time frame: At four, eight and 12 months post-randomisation.
Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.
Time frame: At four, eight and 12 months post-randomisation.
Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.
Time frame: At four, eight and 12 months post-randomisation..
Recruitment SWAT: Proportion of Participants Who Return a Screening Form
Time frame: Enrollment
Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation
Time frame: Enrollment
Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation
Time frame: Three months post-randomisation.
Retention SWAT: Time to Response
Time frame: Four months post-randomisation.
Retention SWAT: Completeness of Response
Time frame: Four months post-randomisation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41013989Cockayne 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.
- Derived from this study: PubMed 41013512Adamson 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.
- Derived from this study: PubMed 39360568Drahota 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.
- National Institute of Health Research (NIHR)Link provided by the sponsor.
- York Trials Unit, University of York, United KingdomLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study data and resources to be shared with researchers upon request. Please contact at given details.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Cockayne principal investigator
University of York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fire and Rescue Service Safe and Well Visit, Self-Determination Theory informed trial invitation letter and Pen included with reminder questionaire in people with Accidental Fall and Quality of Life, run by Caroline Fairhurst at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation. (time frame: Falls per participant over the 12 months from randomisation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717258, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.