Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04717258
Status:
TERMINATED
Last Update Posted:
2025-06-04
First Post:
2020-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005390', 'term': 'Fires'}], 'ancestors': [{'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.cockayne@york.ac.uk', 'phone': '01904321736', 'title': 'Sarah Cockaiyne', 'organization': 'University of York'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study. The start of the adverse event reporting period for each participant was from the date the participant gave consent to be in the study. Adverse events were due to be collected over the 12 month duration the participant was in the study.', 'description': 'Only serious adverse events reportable to the regulatory body Health Research Authority (https://www.hra.nhs.uk/), were reportable on this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Main FIREFLI Trial: Intervention Arm', 'description': '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.\n\nFire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Main FIREFLI Trial: Control Arm', 'description': '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)', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SWAT Intervention', 'description': 'Participants received a study invitation letter based on Self-Determination theory', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SWAT Control Group', 'description': "Participants received a study invitation letter based on 'standard' invitation letter sent out by the York Trials Unit", 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main FIREFLI Trial: Intervention Arm', 'description': '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.\n\nFire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population'}, {'id': 'OG001', 'title': 'Main FIREFLI Trial: Control Arm', 'description': '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)'}], 'timeFrame': 'Falls per participant over the 12 months from randomisation.', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis not undertaken as followup data not collected'}, {'type': 'PRIMARY', 'title': 'Health-related Quality of Life Measured by the EuroQol 5 Dimensions, 5 Level Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Main FIREFLI Trial: Intervention Arm', 'description': '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.\n\nFire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population'}, {'id': 'OG001', 'title': 'Main FIREFLI Trial: Control Arm', 'description': '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)'}], 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis not undertaken as followup data not collected.'}, {'type': 'PRIMARY', 'title': 'Recruitment SWAT: Recruitment to the FIREFLI Trial.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SWAT Intervention', 'description': 'Participants received an study invitation letter based on Self-Determination Theory'}, {'id': 'OG001', 'title': 'SWAT Control Group', 'description': "Participants received a study invitation letter based on 'standard' invitation letter sent out by the York Trials Unit"}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of recruitment - approximately one year.', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention SWAT: Four-month Questionnaire Response Rate.', 'timeFrame': 'Four months from randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'The EuroQol-5D Visual Analogue Scale', 'timeFrame': 'Over 12 months since randomisation', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Time to First Fall and Between Subsequent Falls.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Reporting at Least One Fall.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Reporting Two or More Falls.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Fear of Falling', 'timeFrame': '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.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Universtiy of California Los Angeles (UCLA) 3-item Loneliness Scale', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': "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.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Fall Related Injuries and Costs.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': "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.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Fire Risk Taking Behaviours', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Fire risk taking behaviours measured using participant self-report.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Uptake of Flu Jab', 'timeFrame': 'Over the 12 months from randomisation.', 'description': 'Uptake of flu jab using participant self-reported flu vaccination within the past 12 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Smoking/Vaping Status of Residents Within the Property', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Participant Reported Fire Within the Property That the FRS Attended at Four, Eight and 12 Months Post-randomisation.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Participant reported fire within the property that the FRS attended at four, eight and 12 months post-randomisation', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Fire incident.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.", 'timeFrame': 'At four, eight and 12 months post-randomisation..', 'description': 'Fire incident.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Recruitment SWAT: Proportion of Participants Who Return a Screening Form', 'timeFrame': 'Enrollment', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation', 'timeFrame': 'Enrollment', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation', 'timeFrame': 'Three months post-randomisation.', 'description': "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.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Retention SWAT: Time to Response', 'timeFrame': 'Four months post-randomisation.', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Retention SWAT: Completeness of Response', 'timeFrame': 'Four months post-randomisation.', 'description': 'The number of completed questions on the four month questionnaire.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SWAT Intervention', 'description': 'Participants received an study invitation letter based on Self-Determination Theory'}, {'id': 'FG001', 'title': 'SWAT Control Group', 'description': "Participants received a study invitation letter based on 'standard' invitation letter sent out by the York Trials Unit"}, {'id': 'FG002', 'title': 'Main FIREFLI Trial: Intervention Arm', 'description': '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.\n\nFire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population'}, {'id': 'FG003', 'title': 'Main FIREFLI Trial: Control Arm', 'description': '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)'}, {'id': 'FG004', 'title': 'Retention SWAT Intervention Arm', 'description': 'Participants due to be allocated to this arm were due to be sent a pen with their follow up questionnaire.'}, {'id': 'FG005', 'title': 'Retention SWAT Control Group', 'description': 'Participants who were due to be allocated to this arm were not due to be sent a pen.'}], 'periods': [{'title': 'Main FIREFLI Trial', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Recruitment SWAT', 'milestones': [{'type': 'STARTED', 'comment': '63 participants took part. These participants took part in the main trial but also in an embedded methodological substudy - recruitment Study within a Trial (SWAT). Participants were initially randomised to receive 1 of 2 invitation letters to take part in the study - 37 were allocated to the SWAT intervention and 26 to the SWAT control group. Participants were then randomised to the main FIREFLI trial - 32 to intervention and 31 to control. The periods therefore represent different studies.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The participants recruited to the recruitment Study within a Trial (SWAT) are the same participants as those in the main trial. They are not in addition to those recruited.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Main FIREFLI Trial: Intervention Arm', 'description': '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.\n\nFire and Rescue Service Safe and Well Visit: Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population'}, {'id': 'BG001', 'title': 'Main FIREFLI Trial: Control Arm', 'description': '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)'}, {'id': 'BG002', 'title': 'SWAT Control Group', 'description': "Participants received a study invitation letter based on 'standard' invitation letter sent out by the York Trials Unit"}, {'id': 'BG003', 'title': 'SWAT Intervention', 'description': 'Participants received a study invitation letter based on Self-Determination Theory'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '80.6', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '76.3', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '78.5', 'spread': '5.6', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '78.5', 'spread': '6.0', 'groupId': 'BG002'}, {'value': '78.5', 'spread': '5.5', 'groupId': 'BG003'}, {'value': '78.5', 'spread': '5.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants - all from the UK.'}, {'title': 'EQ5D-5L (5 level EQ-5D) utility index value', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.724', 'spread': '0.203', 'groupId': 'BG000'}, {'value': '0.718', 'spread': '0.252', 'groupId': 'BG001'}, {'value': '0.721', 'spread': '0.227', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.748', 'spread': '0.243', 'groupId': 'BG002'}, {'value': '0.707', 'spread': '0.218', 'groupId': 'BG003'}, {'value': '0.724', 'spread': '0.227', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The EQ-5D-5L comprises 5 dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), each with 5 responses (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=unable to do/extreme problems), which lead to 3125 unique combinations of health states (e.g. 34221). Each health state is mapped to a utility index score on a scale from -0.59 to 1, where negative values correspond to a state worse than death, 0 corresponds to a health state equivalent to being dead and 1 corresponds to perfect health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}, {'title': 'Fallen in past 12 months', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.50', 'groupId': 'BG000'}, {'value': '0.77', 'spread': '1.92', 'groupId': 'BG001'}, {'value': '0.83', 'spread': '1.71', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.36', 'spread': '2.25', 'groupId': 'BG002'}, {'value': '0.49', 'spread': '0.84', 'groupId': 'BG003'}, {'value': '0.84', 'spread': '1.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of falls', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}, {'title': 'EQ5D-5L (5 level EQ-5D) VAS', 'classes': [{'title': 'Main FIREFLI trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '75.8', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '20.7', 'groupId': 'BG001'}, {'value': '74.6', 'spread': '19.8', 'groupId': 'BG004'}]}]}, {'title': 'SWAT trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '75.8', 'spread': '19.2', 'groupId': 'BG002'}, {'value': '74.1', 'spread': '20.5', 'groupId': 'BG003'}, {'value': '74.8', 'spread': '19.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "The visual analogue scale (VAS) records participants' overall evaluation of their health on a scale from 0 (worst imaginable health) to 100 (best imaginable health)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: The main FIREFLI trial and the SWAT are two separate studies involving the same participants.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 1426046, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-13T06:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study consists of a two-arm main trial, with two embedded two-arm SWATs.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2020-12-09', 'resultsFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-24', 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.', 'timeFrame': 'Falls per participant over the 12 months from randomisation.', 'description': '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.'}, {'measure': 'Health-related Quality of Life Measured by the EuroQol 5 Dimensions, 5 Level Version', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.'}, {'measure': 'Recruitment SWAT: Recruitment to the FIREFLI Trial.', 'timeFrame': 'End of recruitment - approximately one year.', 'description': '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.'}, {'measure': 'Retention SWAT: Four-month Questionnaire Response Rate.', 'timeFrame': 'Four months from randomisation.', 'description': '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.'}, {'measure': 'The EuroQol-5D Visual Analogue Scale', 'timeFrame': 'Over 12 months since randomisation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time to First Fall and Between Subsequent Falls.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.'}, {'measure': 'Proportion of Participants Reporting at Least One Fall.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.'}, {'measure': 'Proportion of Participants Reporting Two or More Falls.', 'timeFrame': 'Over the 12 months from randomisation.', 'description': '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.'}, {'measure': 'Fear of Falling', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Universtiy of California Los Angeles (UCLA) 3-item Loneliness Scale', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': "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."}, {'measure': 'Fall Related Injuries and Costs.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': "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."}, {'measure': 'Fire Risk Taking Behaviours', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Fire risk taking behaviours measured using participant self-report.'}, {'measure': 'Uptake of Flu Jab', 'timeFrame': 'Over the 12 months from randomisation.', 'description': 'Uptake of flu jab using participant self-reported flu vaccination within the past 12 months.'}, {'measure': 'Smoking/Vaping Status of Residents Within the Property', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': '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.'}, {'measure': 'Participant Reported Fire Within the Property That the FRS Attended at Four, Eight and 12 Months Post-randomisation.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Participant reported fire within the property that the FRS attended at four, eight and 12 months post-randomisation'}, {'measure': 'Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.', 'timeFrame': 'At four, eight and 12 months post-randomisation.', 'description': 'Fire incident.'}, {'measure': "Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.", 'timeFrame': 'At four, eight and 12 months post-randomisation..', 'description': 'Fire incident.'}, {'measure': 'Recruitment SWAT: Proportion of Participants Who Return a Screening Form', 'timeFrame': 'Enrollment', 'description': '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.'}, {'measure': 'Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation', 'timeFrame': 'Enrollment', 'description': '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.'}, {'measure': 'Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation', 'timeFrame': 'Three months post-randomisation.', 'description': "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."}, {'measure': 'Retention SWAT: Time to Response', 'timeFrame': 'Four months post-randomisation.', 'description': '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.'}, {'measure': 'Retention SWAT: Completeness of Response', 'timeFrame': 'Four months post-randomisation.', 'description': 'The number of completed questions on the four month questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accidental Fall', 'Quality of Life', 'Aged']}, 'referencesModule': {'references': [{'pmid': '41013989', 'type': 'DERIVED', 'citation': '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': '41013512', 'type': 'DERIVED', 'citation': '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': '39360568', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.fundingawards.nihr.ac.uk/award/NIHR128341', 'label': 'National Institute of Health Research (NIHR)'}, {'url': 'https://www.york.ac.uk/healthsciences/research/trials/ytutrialsandstudies/archive/firefli/', 'label': 'York Trials Unit, University of York, United Kingdom'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nTwo 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.', 'detailedDescription': "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.\n\nOne 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.\n\nTo 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.\n\nIn 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.\n\nOnce 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main FIREFLI trial\n\nInclusion Criteria:\n\n* 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\n* Community dwelling\n* Willing to receive a SWV from the FRS\n\nExclusion Criteria:\n\n* Living in a residential or nursing home\n* Bed bound\n* Unable to give informed consent to take part in the study and living alone\n* Had an occupational therapist (OT) visit within the past 12 months\n* Received a SWV from the FRS in the past three years\n* Have been referred to the FRS as an urgent referral\n\nFor 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.\n\nRecruitment Study within a trial (SWAT)\n\nInclusion criteria Any patient identified by the Fire and Rescue Service as eligible to receive a FIREFLI trial invitation pack.\n\nRetention 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.\n\nExclusion 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.'}, 'identificationModule': {'nctId': 'NCT04717258', 'acronym': 'FIREFLI', 'briefTitle': 'Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People', 'organization': {'class': 'OTHER', 'fullName': 'University of York'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FIREFLI Trial Protocol v6.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main FIREFLI trial: Intervention arm', 'description': '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.', 'interventionNames': ['Other: Fire and Rescue Service Safe and Well Visit']}, {'type': 'NO_INTERVENTION', 'label': 'Main FIREFLI trial: Control arm', 'description': '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)'}, {'type': 'EXPERIMENTAL', 'label': 'Recruitment SWAT: Self-Determination Theory informed invitation letter', 'description': 'The recruitment pack to take part in the FIREFLI study will include an invitation letter informed by Self-Determination Theory.', 'interventionNames': ['Other: Self-Determination Theory informed trial invitation letter']}, {'type': 'NO_INTERVENTION', 'label': 'Recruitment SWAT: Standard invitation letter', 'description': "The recruitment pack to take part in the FIREFLI study will include the University of York, York Trials Unit's standard invitation letter"}, {'type': 'EXPERIMENTAL', 'label': 'Retention SWAT: Pen arm', 'description': 'A pen (which has the University of York logo on it) will be included with the first four-month reminder questionnaire.', 'interventionNames': ['Other: Pen included with reminder questionaire']}, {'type': 'NO_INTERVENTION', 'label': 'Retention SWAT: No pen', 'description': 'No pen will be included with the four-month reminder questionnaire.'}], 'interventions': [{'name': 'Fire and Rescue Service Safe and Well Visit', 'type': 'OTHER', 'description': 'Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population', 'armGroupLabels': ['Main FIREFLI trial: Intervention arm']}, {'name': 'Self-Determination Theory informed trial invitation letter', 'type': 'OTHER', 'description': 'Invitation letter to take part in the FIREFLI study informed by Self-Determination Theory', 'armGroupLabels': ['Recruitment SWAT: Self-Determination Theory informed invitation letter']}, {'name': 'Pen included with reminder questionaire', 'type': 'OTHER', 'description': 'A pen will be included with the four-month reminder questionnaire.', 'armGroupLabels': ['Retention SWAT: Pen arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU4 7BB', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Humberside Fire and Rescue Service', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'ME15 6XB', 'city': 'Maidstone', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Kent Fire and Rescue Service', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}], 'overallOfficials': [{'name': 'Sarah Cockayne', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study data and resources to be shared with researchers upon request. Please contact at given details.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caroline Fairhurst', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humberside Fire and Rescue Service', 'class': 'UNKNOWN'}, {'name': 'Leicestershire Partnership NHS Trust', 'class': 'OTHER'}, {'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'Kent Fire and Rescue Service', 'class': 'UNKNOWN'}, {'name': 'James Cook University, Queensland, Australia', 'class': 'OTHER'}, {'name': 'Queensland Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior statistician', 'investigatorFullName': 'Caroline Fairhurst', 'investigatorAffiliation': 'University of York'}}}}