Trial Outcomes & Findings for Safe and Well Visits by the Fire and Rescue Service to Prevent Falls and Improve Quality of Life in Older People (NCT NCT04717258)

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.

The main FIREFLI trial and the SWAT are two separate studies involving the same participants.

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 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.

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.

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 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.

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.

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.

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.

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.

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.

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.

Fire risk taking behaviours measured using participant self-report.

Uptake of flu jab using participant self-reported flu vaccination within the past 12 months.

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.

Participant reported fire within the property that the FRS attended at four, eight and 12 months post-randomisation

Fire incident.

Fire incident.

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.

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.

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.

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.

The number of completed questions on the four month questionnaire.