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

NCT04717258 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-06-04

Study results available
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Summary

FIREFLI is a large, pragmatic, individually randomised, controlled trial with embedded economic and qualitative evaluations. The aim of the research is to see whether Safe and Well Visits delivered by the Fire and Rescue Service will lead to a reduction in the number of falls and an improvement in health-related quality of life in older people. It will also look at the cost-effectiveness of the intervention and explore the acceptability of the Safe and Well Visits to older people and the Fire and Rescue Service.

The investigators will recruit 1156 participants, randomly divided into two equal groups. One group (the intervention group) will receive the Safe and Well Visit at the beginning of the study and the other group (the control group) will receive the visit at the end of the study.

The investigators will collect the number of falls people have using monthly falls calendars and follow up other outcomes by questionnaires at four, eight and 12 months post-randomisation. The investigators will also undertake interviews with some participants and with Fire and Rescue Service staff to explore experiences around the Safe and Well Visits.

Two Studies within a Trial (SWAT) will be carried out to investigate more efficient ways of running trials. The first will test if using a recruitment invitation letter informed by Self-Determination Theory will increase the number of participants who take part in the study. The second will test if including a pen with the reminder four-month questionnaire will increase the number of postal questionnaires returned to the study team.

Conditions

  • Accidental Fall
  • Quality of Life
  • Aged

Interventions

OTHER

Fire 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

OTHER

Self-Determination Theory informed trial invitation letter

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

OTHER

Pen included with reminder questionaire

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

Sponsors & Collaborators

  • Humberside Fire and Rescue Service

    collaborator UNKNOWN
  • Leicestershire Partnership NHS Trust

    collaborator OTHER
  • University of Nottingham

    collaborator OTHER
  • Kent Fire and Rescue Service

    collaborator UNKNOWN
  • James Cook University, Queensland, Australia

    collaborator OTHER
  • Queensland Health

    collaborator OTHER_GOV
  • Caroline Fairhurst

    lead OTHER

Principal Investigators

  • Sarah Cockayne · University of York

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2023-01-31
Completion
2023-07-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04717258 on ClinicalTrials.gov