0 Beoordelingen

ID

14299

Beschrijving

To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT02195284

Link

https://clinicaltrials.gov/show/NCT02195284

Trefwoorden

  1. 08-04-16 08-04-16 -
Geüploaded op

8 april 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Asthma NCT02195284

    Eligibility Asthma NCT02195284

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02195284
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
    Beschrijving

    Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [3,1]
    C0586740 (Able to read)
    SNOMED
    309251006
    UMLS CUI [3,2]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [3,3]
    C0584993 (Able to write)
    SNOMED
    307125007
    UMLS CUI [3,4]
    C0376245 (English Language)
    SNOMED
    297487008
    LOINC
    LA43-5
    UMLS CUI [4,1]
    C0586740 (Able to read)
    SNOMED
    309251006
    UMLS CUI [4,2]
    C0162340 (Comprehension)
    SNOMED
    66216009
    UMLS CUI [4,3]
    C0584993 (Able to write)
    SNOMED
    307125007
    UMLS CUI [4,4]
    C0376241 (Dutch Language)
    SNOMED
    297486004
    age: >=18 years of age
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    gender: male or female subjects.
    Beschrijving

    Gender

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
    Beschrijving

    Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    UMLS CUI [2]
    C0009488 (Comorbidity)
    UMLS CUI [3]
    C0003873 (Rheumatoid Arthritis)
    SNOMED
    69896004
    LOINC
    LA15161-5
    UMLS CUI [4]
    C0026857 (Musculoskeletal Diseases)
    SNOMED
    928000
    UMLS CUI [5]
    C3665347 (Visual Impairment)
    SNOMED
    397540003
    LOINC
    LA17314-8
    UMLS CUI [6]
    C0011581 (Depressive disorder)
    SNOMED
    35489007
    LOINC
    LA10576-9
    UMLS CUI [7]
    C0003467 (Anxiety)
    SNOMED
    48694002
    LOINC
    MTHU013060
    UMLS CUI [8]
    C0021461 (Inhaler)
    SNOMED
    420317006
    asthma treatment: all subjects should be currently receiving treatment for asthma.
    Beschrijving

    Therapeutic procedure Asthma

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0004096 (Asthma)
    SNOMED
    195967001
    LOINC
    MTHU020815
    must be naive to using ellipta inhaler and at least one other inhaler device.
    Beschrijving

    Inhaler | Inhaler aid device

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021461 (Inhaler)
    SNOMED
    420317006
    UMLS CUI [2]
    C0461716 (Inhaler aid device)
    SNOMED
    335018002
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
    Beschrijving

    Chronic Obstructive Airway Disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
    Beschrijving

    Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    UMLS CUI [2]
    C0022951 (Lactose Intolerance)
    SNOMED
    782415009
    UMLS CUI [3,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [3,2]
    C0126791 (magnesium stearate)
    SNOMED
    40471006
    subjects who are currently participating in another randomised pharmacological interventional trial.
    Beschrijving

    Study Subject Participation Status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
    Beschrijving

    Unable to read | Compliance behavior Limited

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0586741 (Unable to read)
    SNOMED
    309252004
    UMLS CUI [2,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8

    Similar models

    Eligibility Asthma NCT02195284

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT02195284
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent | Compliance behavior | Able to read Comprehension Able to write English Language | Dutch Language
    Item
    informed consent: subject must give their signed and dated written informed consent to participate; subject understands and is willing, able, and likely to comply with study procedures and restrictions; subject must be able to read, comprehend, and record information in dutch and/or english
    boolean
    C0021430 (UMLS CUI [1])
    C1321605 (UMLS CUI [2])
    C0586740 (UMLS CUI [3,1])
    C0162340 (UMLS CUI [3,2])
    C0584993 (UMLS CUI [3,3])
    C0376245 (UMLS CUI [3,4])
    C0586740 (UMLS CUI [4,1])
    C0162340 (UMLS CUI [4,2])
    C0584993 (UMLS CUI [4,3])
    C0376241 (UMLS CUI [4,4])
    Age
    Item
    age: >=18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Gender
    Item
    gender: male or female subjects.
    boolean
    C0079399 (UMLS CUI [1])
    Asthma | Comorbidity | Rheumatoid Arthritis | Musculoskeletal Diseases | Visual Impairment | Depressive disorder | Anxiety | Inhaler
    Item
    asthma diagnosis: a diagnosis of asthma as defined by the national institutes of health. comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
    boolean
    C0004096 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    C0003873 (UMLS CUI [3])
    C0026857 (UMLS CUI [4])
    C3665347 (UMLS CUI [5])
    C0011581 (UMLS CUI [6])
    C0003467 (UMLS CUI [7])
    C0021461 (UMLS CUI [8])
    Therapeutic procedure Asthma
    Item
    asthma treatment: all subjects should be currently receiving treatment for asthma.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    Inhaler | Inhaler aid device
    Item
    must be naive to using ellipta inhaler and at least one other inhaler device.
    boolean
    C0021461 (UMLS CUI [1])
    C0461716 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Chronic Obstructive Airway Disease
    Item
    chronic obstructive pulmonary disease (copd): subjects with a current diagnosis of copd only.
    boolean
    C0024117 (UMLS CUI [1])
    Medical contraindication | Lactose Intolerance | Hypersensitivity Magnesium stearate
    Item
    contraindications: a history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
    boolean
    C1301624 (UMLS CUI [1])
    C0022951 (UMLS CUI [2])
    C0020517 (UMLS CUI [3,1])
    C0126791 (UMLS CUI [3,2])
    Study Subject Participation Status
    Item
    subjects who are currently participating in another randomised pharmacological interventional trial.
    boolean
    C2348568 (UMLS CUI [1])
    Unable to read | Compliance behavior Limited
    Item
    inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
    boolean
    C0586741 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])

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