Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04717258
Eligibility Criteria:
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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04717258
Study Brief:
Protocol Section:
NCT04717258