ID

29619

Description

Hepatitis B Acceptability and Vaccination Incentive Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00744289

Link

https://clinicaltrials.gov/show/NCT00744289

Keywords

Versions (1)
  1. 4/10/18 4/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
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 Hepatitis B NCT00744289

English

Eligibility Hepatitis B NCT00744289

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 16 years and above.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
injected drugs at least once in the preceding six months, or (i) use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, and (ii) spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
Description

Injected drugs | Illicit drug use | Use of Non-Prescription Drugs | Exception Marihuana | Amphetamine | Cocaine | Methamphetamine | Heroin

Data type

boolean

Alias
UMLS CUI [1]
C0683092
UMLS CUI [2]
C0281875
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0013231
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0024808
UMLS CUI [5]
C0002658
UMLS CUI [6]
C0009170
UMLS CUI [7]
C0025611
UMLS CUI [8]
C0011892
no previous hepatitis b infection, and a maximum of one previous dose of hepatitis b vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
Description

Hepatitis B Previous Absent | Hepatitis B vaccination Dose Quantity Maximum | Infection status Unknown | Vaccination status Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0474232
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0806909
UMLS CUI [3,1]
C0517627
UMLS CUI [3,2]
C0439673
UMLS CUI [4,1]
C1443394
UMLS CUI [4,2]
C0439673
ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.
Description

Informed Consent | Protocol Compliance | Vaccination Attend | Follow-up Attend

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C0042196
UMLS CUI [3,2]
C1999232
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C1999232
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of natural or vaccine-induced immunity.
Description

Immunity, Innate | Immunity Vaccine Induced

Data type

boolean

Alias
UMLS CUI [1]
C0020969
UMLS CUI [2,1]
C0020965
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C0205263
previous exposure or two+ vaccinations (as identified by self-report), where hbv surface antibody >= 10 miu/ml
Description

Exposure to Vaccination | Hepatitis B surface antibody measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0042196
UMLS CUI [2]
C0201478
serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
Description

Mental disorders Impact Protocol Compliance | Physical illness Impact Protocol Compliance | Disability Impact Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0231170
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C0525058
insufficient english language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
Description

English Language skills Insufficient | Informed Consent Limited | Patient interview Completion Limited | Clinical Trial Subject Questionnaire Completion Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C1145677
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C0683518
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C3890411
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0439801
human immunodeficiency virus infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
refusal to be vaccinated against hepatitis b virus (hbv)
Description

Hepatitis B vaccination Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C1705116
Back to the top of the page

Similar models

Eligibility Hepatitis B NCT00744289

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 16 years and above.
boolean
C0001779 (UMLS CUI [1])
Injected drugs | Illicit drug use | Use of Non-Prescription Drugs | Exception Marihuana | Amphetamine | Cocaine | Methamphetamine | Heroin
Item
injected drugs at least once in the preceding six months, or (i) use of any illegal/non-prescription drug apart from cannabis (e.g., speed, coke, ice, heroin) in the last three months, and (ii) spent time with 2 or more people who inject drugs on a weekly or more frequent basis in the last three months.
boolean
C0683092 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C1524063 (UMLS CUI [3,1])
C0013231 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0024808 (UMLS CUI [4,2])
C0002658 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0025611 (UMLS CUI [7])
C0011892 (UMLS CUI [8])
Hepatitis B Previous Absent | Hepatitis B vaccination Dose Quantity Maximum | Infection status Unknown | Vaccination status Unknown
Item
no previous hepatitis b infection, and a maximum of one previous dose of hepatitis b vaccination, or unknown infection and vaccination status, based on self-report and, where available, medical records
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0474232 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0806909 (UMLS CUI [2,4])
C0517627 (UMLS CUI [3,1])
C0439673 (UMLS CUI [3,2])
C1443394 (UMLS CUI [4,1])
C0439673 (UMLS CUI [4,2])
Informed Consent | Protocol Compliance | Vaccination Attend | Follow-up Attend
Item
ability to provide informed consent, to be randomized and attend vaccinations over a period of three weeks and to attend follow-up at 12 weeks post-randomisation.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0042196 (UMLS CUI [3,1])
C1999232 (UMLS CUI [3,2])
C3274571 (UMLS CUI [4,1])
C1999232 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Immunity, Innate | Immunity Vaccine Induced
Item
evidence of natural or vaccine-induced immunity.
boolean
C0020969 (UMLS CUI [1])
C0020965 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0205263 (UMLS CUI [2,3])
Exposure to Vaccination | Hepatitis B surface antibody measurement
Item
previous exposure or two+ vaccinations (as identified by self-report), where hbv surface antibody >= 10 miu/ml
boolean
C0332157 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0201478 (UMLS CUI [2])
Mental disorders Impact Protocol Compliance | Physical illness Impact Protocol Compliance | Disability Impact Protocol Compliance
Item
serious mental or physical illness or disability likely to impact on capacity to complete the study procedures
boolean
C0004936 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683323 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0231170 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
English Language skills Insufficient | Informed Consent Limited | Patient interview Completion Limited | Clinical Trial Subject Questionnaire Completion Limited
Item
insufficient english language skills that will impair ability to give informed consent or provide reliable responses to study interviews /questionnaires
boolean
C0376245 (UMLS CUI [1,1])
C1145677 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0683518 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C3890411 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
HIV Infection
Item
human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B vaccination Refused
Item
refusal to be vaccinated against hepatitis b virus (hbv)
boolean
C0474232 (UMLS CUI [1,1])
C1705116 (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