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])
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])