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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Recruitment SWAT: Recruitment to the FIREFLI Trial.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main FIREFLI trial
- •Inclusion Criteria:
- •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
排除标准
- •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
- •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.
结局指标
主要结局
Recruitment SWAT: Recruitment to the FIREFLI Trial.
时间窗: 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.
Main FIREFLI Trial: The Number of Self-reported Falls Per Participant Over the 12 Months From Randomisation.
时间窗: 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
时间窗: 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.
Retention SWAT: Four-month Questionnaire Response Rate.
时间窗: 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
时间窗: 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.
次要结局
- Participant Reported Fire Within the Property That Did Not Require the FRS to Attend.(At four, eight and 12 months post-randomisation.)
- Attendances to Participants' Homes for Fire Related Incidents as Recorded by the FRS.(At four, eight and 12 months post-randomisation..)
- Time to First Fall and Between Subsequent Falls.(Over the 12 months from randomisation.)
- Proportion of Participants Reporting at Least One Fall.(Over the 12 months from randomisation.)
- Proportion of Participants Reporting Two or More Falls.(Over the 12 months from randomisation.)
- Fear of Falling(At four, eight and 12 months post-randomisation measured by asking participants to score how often they have worried about having a fall in the past four weeks.)
- Universtiy of California Los Angeles (UCLA) 3-item Loneliness Scale(At four, eight and 12 months post-randomisation.)
- Fall Related Injuries and Costs.(At four, eight and 12 months post-randomisation.)
- Fire Risk Taking Behaviours(At four, eight and 12 months post-randomisation.)
- Uptake of Flu Jab(Over the 12 months from randomisation.)
- Smoking/Vaping Status of Residents Within the Property(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.(At four, eight and 12 months post-randomisation.)
- Recruitment SWAT: Proportion of Participants Who Return a Screening Form(Enrollment)
- Recruitment SWAT: Proportion of Participants Who Are Eligible for Randomisation(Enrollment)
- Recruitment SWAT: Retention in the Trial at Three Months Post-randomisation(Three months post-randomisation.)
- Retention SWAT: Time to Response(Four months post-randomisation.)
- Retention SWAT: Completeness of Response(Four months post-randomisation.)
研究者
Caroline Fairhurst
Senior statistician
University of York