NCT02728674

Brief Summary

This is a web-based randomized survey to evaluate management of respiratory symptoms among physicians in Sweden. The aim of this study is to determine if there is a gender bias in the diagnosis of COPD and how often physicians identify that chronic refractory breathlessness requires treatment as compared to refractory pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

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

March 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

March 24, 2016

Last Update Submit

August 23, 2017

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDBreathlessnessSymptomOpioidsGender bias

Outcome Measures

Primary Outcomes (1)

  • COPD treatment in the Questionnaire

    Would there be a difference between the hypothetical case with breathlessness compared to the otherwise identical case with pain instead of breathlessness regarding: 1. Proportion of study participants that consider that the patient in the case is not optimally treated; 2. Proportion of study participants that consider morphine as either primary or secondary treatment option

    through study completion, up to 6 months

Secondary Outcomes (2)

  • Gender bias in COPD diagnosis in the Questionnaire

    through study completion, up to 6 months

  • Symptomatic treatment in the Questionnaire

    through study completion, up to 6 months

Other Outcomes (3)

  • Non-randomized measurements in the Questionnaire

    through study completion, up to 6 months

  • Chosen evidence-grades as non-randomized measurements in the Questionnaire

    through study completion, up to 6 months

  • Chosen potential risks as non-randomized measurements in the Questionnaire

    through study completion, up to 6 months

Study Arms (4)

Man+Breathlessness

OTHER

Person in the case is a male. Symptom in the case is breathlessness.

Other: Person in the case is a male.Other: Symptom in the case is breathlessness.

Man+Pain

OTHER

Person in the case is a male. Symptom in the case is pain.

Other: Person in the case is a male.Other: Symptom in the case is pain.

Woman+Breathlessness

OTHER

Person in the case is a female. Symptom in the case is breathlessness.

Other: Person in the case is a female.Other: Symptom in the case is breathlessness.

Woman+Pain

OTHER

Person in the case is a female.Symptom in the case is pain.

Other: Person in the case is a female.Other: Symptom in the case is pain.

Interventions

Person in the case is a male.OTHER

Person in the case is a male.

Man+BreathlessnessMan+Pain
Person in the case is a female.OTHER

Person in the case is a female.

Woman+BreathlessnessWoman+Pain
Symptom in the case is breathlessness.OTHER

Symptom in the case is breathlessness.

Man+BreathlessnessWoman+Breathlessness
Symptom in the case is pain.OTHER

Symptom in the case is pain.

Man+PainWoman+Pain

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Certified physician
  • Treats patients with respiratory symptoms and reduced physical activity
  • Able to read and understand a hypothetical case in Swedish

You may not qualify if:

  • Knowledge about the aim and/or design of the study, or
  • Previous participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory Medicine and Allergology

Lund, Skåne County, 21100, Sweden

Location

Related Publications (1)

  • Ahmadi Z, Sandberg J, Shannon-Honson A, Vandersman Z, Currow DC, Ekstrom M. Is chronic breathlessness less recognised and treated compared with chronic pain? A case-based randomised controlled trial. Eur Respir J. 2018 Sep 15;52(3):1800887. doi: 10.1183/13993003.00887-2018. Print 2018 Sep.

    PMID: 30002106DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaSexism

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Magnus Ekström, MD, PhD

    Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 5, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 24, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)