ID

14350

Description

Children With Asthma in New Orleans After Hurricane Katrina; ODM derived from: https://clinicaltrials.gov/show/NCT00426634

Lien

https://clinicaltrials.gov/show/NCT00426634

Mots-clés

  1. 11/04/2016 11/04/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

11 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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    Eligibility Asthma NCT00426634

    Eligibility Asthma NCT00426634

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00426634
    Criteria
    Description

    Criteria

    a child will be included in the heal intervention study if he or she:
    Description

    inclusion

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    1. is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in orleans parish or surrounding areas impacted by flooding.
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (criteria 3) for more than one year.
    Description

    asthma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    3. is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b):
    Description

    long-term asthma control therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004096
    UMLS CUI [1,2]
    C0087111
    3a. evidence of persistent asthma as defined by the national asthma education and prevention program (naepp) of the national heart lung and blood institute expert panel report 2: guidelines for the diagnosis and management of asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (metered dose inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise.
    Description

    persistent asthma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3266628
    3b. evidence of uncontrolled disease as defined by at least one of the following additional criteria:
    Description

    uncontrolled disease

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0205318
    UMLS CUI [1,2]
    C0004096
    i. one asthma-related unscheduled visit to an emergency department (ed), urgent care (uc), or clinic in the previous 12 months.
    Description

    emergency department visit

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0583237
    ii. one asthma-related overnight hospitalization in the previous 12 months.
    Description

    hospitalization for asthma

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0004096
    iii. one or more bursts of oral corticosteroids or equivalent in the previous 12 months.
    Description

    oral corticosteroids

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    4) has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study.
    Description

    parent or legal guardian willing to sign the written informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    5) is willing to sign the assent form, if age appropriate.
    Description

    consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    a child will be excluded from the heal intervention study if she or he:
    Description

    exclusion

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2828389
    1. is defined as having mild intermittent asthma at baseline evaluation.
    Description

    mild intermittent asthma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1960045
    2. has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
    Description

    asthma exacerbation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0349790
    UMLS CUI [1,2]
    C2826244
    3. has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including juvenile diabetes mellitus, hypo- or hyper- thyroidism, hemophilia, von willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin e syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
    Description

    comorbidity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    4. has not had a home evaluation completed within 4-6 weeks of the screening visit (may be re-screened).
    Description

    home evaluation

    Type de données

    boolean

    5. lives with a foster parent.
    Description

    foster parent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0337468
    6. has caregiver (typically the parent or guardian) who does not have access to a phone.
    Description

    caregiver with no access to a phone

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0085537
    UMLS CUI [2]
    C0745029
    7. plans to move out of the recruitment area over the next year.
    Description

    move out

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1299988
    one child from each household will be selected to participate in the study. in the case of multiple eligible children, the youngest child will be included in the study.
    Description

    child participation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0680063
    UMLS CUI [1,2]
    C2348568

    Similar models

    Eligibility Asthma NCT00426634

    1. StudyEvent: Eligibility
      1. Eligibility Asthma NCT00426634
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    inclusion
    Item
    a child will be included in the heal intervention study if he or she:
    boolean
    C1512693 (UMLS CUI [1])
    age
    Item
    1. is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in orleans parish or surrounding areas impacted by flooding.
    boolean
    C0001779 (UMLS CUI [1])
    asthma
    Item
    2. has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (criteria 3) for more than one year.
    boolean
    C0004096 (UMLS CUI [1])
    long-term asthma control therapy
    Item
    3. is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b):
    boolean
    C0004096 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    persistent asthma
    Item
    3a. evidence of persistent asthma as defined by the national asthma education and prevention program (naepp) of the national heart lung and blood institute expert panel report 2: guidelines for the diagnosis and management of asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (metered dose inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise.
    boolean
    C3266628 (UMLS CUI [1])
    uncontrolled disease
    Item
    3b. evidence of uncontrolled disease as defined by at least one of the following additional criteria:
    boolean
    C0205318 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    emergency department visit
    Item
    i. one asthma-related unscheduled visit to an emergency department (ed), urgent care (uc), or clinic in the previous 12 months.
    boolean
    C0583237 (UMLS CUI [1])
    hospitalization for asthma
    Item
    ii. one asthma-related overnight hospitalization in the previous 12 months.
    boolean
    C0019993 (UMLS CUI [1,1])
    C0004096 (UMLS CUI [1,2])
    oral corticosteroids
    Item
    iii. one or more bursts of oral corticosteroids or equivalent in the previous 12 months.
    boolean
    C0001617 (UMLS CUI [1])
    parent or legal guardian willing to sign the written informed consent
    Item
    4) has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study.
    boolean
    C0021430 (UMLS CUI [1])
    consent
    Item
    5) is willing to sign the assent form, if age appropriate.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    exclusion
    Item
    a child will be excluded from the heal intervention study if she or he:
    boolean
    C2828389 (UMLS CUI [1])
    mild intermittent asthma
    Item
    1. is defined as having mild intermittent asthma at baseline evaluation.
    boolean
    C1960045 (UMLS CUI [1])
    asthma exacerbation
    Item
    2. has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
    boolean
    C0349790 (UMLS CUI [1,1])
    C2826244 (UMLS CUI [1,2])
    comorbidity
    Item
    3. has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including juvenile diabetes mellitus, hypo- or hyper- thyroidism, hemophilia, von willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin e syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
    boolean
    C0009488 (UMLS CUI [1])
    home evaluation
    Item
    4. has not had a home evaluation completed within 4-6 weeks of the screening visit (may be re-screened).
    boolean
    foster parent
    Item
    5. lives with a foster parent.
    boolean
    C0337468 (UMLS CUI [1])
    caregiver with no access to a phone
    Item
    6. has caregiver (typically the parent or guardian) who does not have access to a phone.
    boolean
    C0085537 (UMLS CUI [1])
    C0745029 (UMLS CUI [2])
    move out
    Item
    7. plans to move out of the recruitment area over the next year.
    boolean
    C1299988 (UMLS CUI [1])
    child participation
    Item
    one child from each household will be selected to participate in the study. in the case of multiple eligible children, the youngest child will be included in the study.
    boolean
    C0680063 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])

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