ID

14350

Description

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

Link

https://clinicaltrials.gov/show/NCT00426634

Keywords

Versions (1)
  1. 4/11/16 4/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

April 11, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Asthma NCT00426634

English

Eligibility Asthma NCT00426634

1 forms  
  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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

boolean

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

hospitalization for asthma

Data type

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

Data type

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

Data type

boolean

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

consent

Data type

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

Data type

boolean

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

mild intermittent asthma

Data type

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

Data type

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

Data type

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

Data type

boolean

5. lives with a foster parent.
Description

foster parent

Data type

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

Data type

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

Data type

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0680063
UMLS CUI [1,2]
C2348568
Back to the top of the page

Similar models

Eligibility Asthma NCT00426634

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00426634
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial