NCT04749966

Brief Summary

Emergency Service teams operate in some of the most challenging workplaces and experience higher rates of mental ill health than the general population. Effective interventions are required to enhance wellbeing, but as a first step it is crucial to understand the context through which to develop these initiatives. This preliminary study will test the feasibility of implementing a larger study to map the relationship between physical responses associated with levels of stress (heart rate variability) and personal, social and organisational factors that mediate these responses. In doing so, it is hoped to provide an insight into factors that shape emergency staff members' response to stress to help develop and personalise wellbeing initiatives.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

February 9, 2022

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

January 29, 2021

Last Update Submit

February 8, 2022

Conditions

Keywords

Emergency serviceswellbeingstressphysiological responsessubjective mediators

Outcome Measures

Primary Outcomes (6)

  • Feasibility of study recruitment - the number of staff volunteering to take part

    The number of staff volunteering to take part

    From the start to the end of recruitment at each participating site, approximately 4 weeks

  • Feasibility of study recruitment - the proportion of staff targeted through study advertising who volunteer to take part

    The proportion of staff estimated to have been targeted through study advertising who volunteer to take part

    From the start to the end of recruitment at each participating site, approximately 4 weeks

  • Feasibility of study recruitment - the proportion of staff volunteering to take part in the study who are eligible

    The proportion of staff volunteering to take part in the study who are eligible

    From the start to the end of recruitment at each participating site, approximately 4 weeks

  • Adherence to heart rate monitoring during 3-day lifestyle assessment

    The proportion of time the heart rate monitor was worn by participants measured using data collected by the monitor

    At Day 3 of the lifestyle assessment

  • Adherence to completion of online journal during 3-day lifestyle assessment

    The proportion of participants completing the journal

    At Day 3 of the lifestyle assessment

  • Feasibility of conducting interviews

    The proportion of participants in whom an interview is arranged and completed

    On completion of interviews i.e. at approximately 8 weeks

Secondary Outcomes (2)

  • Heart rate variance

    Measured during lifestyle assessment over a period of 3 days - at approximately 3 weeks post-recruitment

  • Subjective mediators of stress

    On completion of interviews i.e. at approximately 8 weeks

Study Arms (1)

Emergency services staff

Emergency Services staff recruited from the Ambulance, Police, and Fire and Rescue Services.

Other: This is an observational study, there are no interventions

Interventions

This is an observational study, there are no interventions

Emergency services staff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A purposive, non-probability sample will be selected and recruited comprising ten operational shift working staff from each of three emergency services (Essex Police, Essex County Fire and Rescue Service and East of England Ambulance Trust).

You may qualify if:

  • are aged 18 or older
  • full-time employees
  • work shift patterns and will be on-duty during the study period

You may not qualify if:

  • off-duty or on leave during the study period
  • part-time (or on-call) employees
  • not working shift patterns
  • currently taking part in research that may impact on results, design or scientific value of this study (or other studies)
  • not able to read or understand the English Language as it will not be possible to provide translation services for the study
  • In addition, the results from the heart rate monitor may be unreliable with certain medical conditions and, as such, staff will not be able to take part if they have had a heart transplant or if they have a pacemaker, heart disease, atrial fibrillation, atrial flutter or uncontrolled thyroid disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Moore

Chelmsford, East of England, CM1 1SQ, United Kingdom

Location

Study Officials

  • Enrico Dippenaar

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 11, 2021

Study Start

February 15, 2021

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

February 9, 2022

Record last verified: 2021-10

Locations