NCT04948255

Brief Summary

This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

PandemicsPrimary health care

Outcome Measures

Primary Outcomes (1)

  • Measurement of stress across the workforce

    Work-related stress (WRS) is measured using the Management Standards Indicator Tool (MSIT) on a Likert scale of 1-5 with a higher number indicating less WRS. A measurement is made at baseline and during the Covid-19 pandemic.

    24 months

Secondary Outcomes (1)

  • Measurement of stress by type of role

    24 months

Study Arms (1)

Healthcare Workers at the Gill Medical Centre

Clinical and non-clinical staff at the Gill Medical Centre will complete a validated stress questionnaire during the Covid-19 pandemic. A baseline was established in May, 2019.

Other: Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult health professionals and administration staff

You may qualify if:

  • Primary healthcare staff working at the Gill Medical Centre for at least two months prior to assessment.

You may not qualify if:

  • Any staff member employed for less than two months, those who were off work due to non- stress related long-term leave or incomplete submissions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Gill Medical Centre

Salford, Greater Manchester, M28 3DR, United Kingdom

Location

MeSH Terms

Conditions

Occupational StressCOVID-19

Interventions

Health

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Ashleigh Ward, MBChB

    Salford Royal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Practitioner

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 1, 2021

Study Start

April 1, 2019

Primary Completion

March 29, 2021

Study Completion

June 29, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Sharing of collected data with researchers using the same tool to assess work-related stress.

Shared Documents
SAP, CSR
Time Frame
Data available now 29/06/2021 to 29/06/2031.
Access Criteria
E-mail: faizan@doctors.org.uk with name, contact details and study purpose.

Locations