NCT04226040

Brief Summary

This study explores whether and how DOW, as a PRO marker, can contribute to triage in the Emergency Departments. The study is designed as a mixed-method study consisting of a survey among acutely ill patients and qualitative semi-structured interviews.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
944

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

January 9, 2020

Last Update Submit

May 11, 2023

Conditions

Keywords

degree-of-worryillness perceptionacute illnessemergency department

Outcome Measures

Primary Outcomes (1)

  • DOW and illness perception

    Self-reported degree-of-worry during acute illness scored on a 1-10 scale (1=minimal concern, 10=maximum concern) and illness perception measured using the Brief illness perception Questionnarie

    30 minutes

Secondary Outcomes (2)

  • DOW and re-presentation in the Emergency Department

    30 days

  • DOW and patient barriers

    30 minutes

Study Arms (1)

DOW and illness perception

Exploration of the association between DOW and illness perception

Behavioral: DOW and illness perception

Interventions

Acutely ill patients are exposed to a survey regarding their degree of worry and illness perception

DOW and illness perception

Eligibility Criteria

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

The survey: 1004 adults (≥18 years of age) who accept to participate in the study. The patients are at the Emergency Department due to acute illness. The interviews: of the 1004 patients 10 (+/- 10 patients are invited to participate in a semi-structured interview. The recruitment is based on purposeful sampling with maximum variation.

You may qualify if:

  • ≥18 years of age
  • cognitively intact
  • consent to participation.

You may not qualify if:

  • patients arriving to the ED regarding injury
  • patient with the highest triage level
  • demented patients
  • intoxicated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Jensen AN, Kallemose T, Frostholm L, Gamst-Jensen H. Correlation between illness perceptions and self-reported degree-of-worry in somatic ill patients in emergency care: a Danish cross-sectional study. BMJ Open. 2024 Nov 1;14(10):e089595. doi: 10.1136/bmjopen-2024-089595.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 13, 2020

Primary Completion

December 19, 2020

Study Completion

December 19, 2020

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations