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Management of Patients With Respiratory Symptoms in Sweden

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728674
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Magnus Ekström, Skane University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Other: Person in the case is a male. Other: Person in the case is a female. Other: Symptom in the case is breathlessness. Other: Symptom in the case is pain. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Management of Patients With Respiratory Symptoms in Sweden
Actual Study Start Date : September 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Man+Breathlessness
Person in the case is a male. Symptom in the case is breathlessness.
Other: Person in the case is a male.
Person in the case is a male.

Other: Symptom in the case is breathlessness.
Symptom in the case is breathlessness.

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

Other: Symptom in the case is pain.
Symptom in the case is pain.

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

Other: Symptom in the case is breathlessness.
Symptom in the case is breathlessness.

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

Other: Symptom in the case is pain.
Symptom in the case is pain.




Primary Outcome Measures :
  1. COPD treatment in the Questionnaire [ Time Frame: through study completion, up to 6 months ]

    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


Secondary Outcome Measures :
  1. Gender bias in COPD diagnosis in the Questionnaire [ Time Frame: through study completion, up to 6 months ]

    Would there be a difference between the cases with a male respective female patient regarding:

    • Proportion of study participants that consider COPD diagnosis;
    • Proportion of study participants that consider spirometry for further diagnostics

  2. Symptomatic treatment in the Questionnaire [ Time Frame: through study completion, up to 6 months ]

    Would there be a difference between the case with breathlessness compared with the case with pain regarding:

    • Chosen treatment options;
    • Reasons not to choose treatment with opioids Chosen treatment options Reasons not to choose treatment with opioids


Other Outcome Measures:
  1. Non-randomized measurements in the Questionnaire [ Time Frame: through study completion, up to 6 months ]
    Proportion of study participants that consider the described breathlessness to be refractory

  2. Chosen evidence-grades as non-randomized measurements in the Questionnaire [ Time Frame: through study completion, up to 6 months ]
    Chosen evidence-grades for treatment options of refractory breathlessness

  3. Chosen potential risks as non-randomized measurements in the Questionnaire [ Time Frame: through study completion, up to 6 months ]
    Chosen potential risks with opioid treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (all required):

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728674


Locations
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Sweden
Department of Respiratory Medicine and Allergology
Lund, Skane, Sweden, 21100
Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Magnus Ekström, MD, PhD Department of Medicine, Blekinge Hospital, SE-37185 Karlskrona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magnus Ekström, MD, PhD, Skane University Hospital
ClinicalTrials.gov Identifier: NCT02728674    
Other Study ID Numbers: CASE2016
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Magnus Ekström, Skane University Hospital:
COPD
Breathlessness
Symptom
Opioids
Gender bias
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Signs and Symptoms, Respiratory
Lung Diseases
Respiratory Tract Diseases