ID

39674

Description

A Health Intervention to Prevent Depression Hepatitis C Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01890083

Link

https://clinicaltrials.gov/show/NCT01890083

Keywords

Versions (1)
  1. 2/9/20 2/9/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01890083

English

Eligibility Hepatitis C NCT01890083

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with hepatitis c and prescribed ifn-α
Description

Hepatitis C | Interferon-alpha prescribed

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C0278329
ability to understand and willingness to provide written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing to provide contact information.
Description

Contact Information

Data type

boolean

Alias
UMLS CUI [1]
C1880174
medical clearance with protocol-defined stress testing (in accordance with american college of sports medicine (acsm) guidelines) from protocol approved medical personnel. details of guidelines and related testing protocol are provided in the study manual of procedures.
Description

Stress test

Data type

boolean

Alias
UMLS CUI [1]
C0015260
able to comprehend and communicate in english.
Description

Language comprehension English Language | Able to communicate English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a medical condition contraindicating exercise participation
Description

Medical condition Contraindicated Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C0015259
are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
Description

Moderate physical activity days per week Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C4482418
UMLS CUI [1,2]
C0677547
UMLS CUI [1,3]
C0449238
have been diagnosed with current major depressive disorder or are currently receiving antidepressant medication treatment (including ssris and snris)
Description

Major Depressive Disorder | Antidepressant therapy | Selective Serotonin Reuptake Inhibitors | SNRIs

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C1096649
UMLS CUI [3]
C0360105
UMLS CUI [4]
C1579361
currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site pi, medical personnel, or designee.
Description

High suicide risk | High risk Completion of clinical trial Unable | Psychiatric hospitalization Required | Suicide attempt | Suicidality | Self Mutilation | Self-Injurious Behavior | Destructive behavior

Data type

boolean

Alias
UMLS CUI [1]
C1271074
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C2732579
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0748061
UMLS CUI [3,2]
C1514873
UMLS CUI [4]
C0038663
UMLS CUI [5]
C3166387
UMLS CUI [6]
C0036601
UMLS CUI [7]
C0085271
UMLS CUI [8]
C0233520
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
current psychotic disorder. other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
Description

Psychotic Disorder | Comorbid mental disorder | Safety Issue | Intervention Completion Difficult

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C4540884
UMLS CUI [3]
C2911688
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0332218
anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the pi or designee.
Description

Circumstances Completion of clinical trial Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0680082
UMLS CUI [1,2]
C2732579
UMLS CUI [1,3]
C0750558
any reason not listed herein yet, determined by the pi, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the pi, medical personnel, or designee make participation in the study hazardous.
Description

Factor Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
Description

Study Subject Participation Status | Participation Research study Contraindicated

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0681814
UMLS CUI [2,3]
C1444657
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Similar models

Eligibility Hepatitis C NCT01890083

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C | Interferon-alpha prescribed
Item
diagnosed with hepatitis c and prescribed ifn-α
boolean
C0019196 (UMLS CUI [1])
C0002199 (UMLS CUI [2,1])
C0278329 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and willingness to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Contact Information
Item
willing to provide contact information.
boolean
C1880174 (UMLS CUI [1])
Stress test
Item
medical clearance with protocol-defined stress testing (in accordance with american college of sports medicine (acsm) guidelines) from protocol approved medical personnel. details of guidelines and related testing protocol are provided in the study manual of procedures.
boolean
C0015260 (UMLS CUI [1])
Language comprehension English Language | Able to communicate English Language
Item
able to comprehend and communicate in english.
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Contraindicated Exercise
Item
have a medical condition contraindicating exercise participation
boolean
C3843040 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
Moderate physical activity days per week Duration
Item
are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
boolean
C4482418 (UMLS CUI [1,1])
C0677547 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Major Depressive Disorder | Antidepressant therapy | Selective Serotonin Reuptake Inhibitors | SNRIs
Item
have been diagnosed with current major depressive disorder or are currently receiving antidepressant medication treatment (including ssris and snris)
boolean
C1269683 (UMLS CUI [1])
C1096649 (UMLS CUI [2])
C0360105 (UMLS CUI [3])
C1579361 (UMLS CUI [4])
High suicide risk | High risk Completion of clinical trial Unable | Psychiatric hospitalization Required | Suicide attempt | Suicidality | Self Mutilation | Self-Injurious Behavior | Destructive behavior
Item
currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site pi, medical personnel, or designee.
boolean
C1271074 (UMLS CUI [1])
C4319571 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0748061 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0038663 (UMLS CUI [4])
C3166387 (UMLS CUI [5])
C0036601 (UMLS CUI [6])
C0085271 (UMLS CUI [7])
C0233520 (UMLS CUI [8])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Psychotic Disorder | Comorbid mental disorder | Safety Issue | Intervention Completion Difficult
Item
current psychotic disorder. other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
boolean
C0033975 (UMLS CUI [1])
C4540884 (UMLS CUI [2])
C2911688 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0332218 (UMLS CUI [4,3])
Circumstances Completion of clinical trial Unlikely
Item
anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the pi or designee.
boolean
C0680082 (UMLS CUI [1,1])
C2732579 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Factor Study Subject Participation Status At risk
Item
any reason not listed herein yet, determined by the pi, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the pi, medical personnel, or designee make participation in the study hazardous.
boolean
C1521761 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Study Subject Participation Status | Participation Research study Contraindicated
Item
are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
boolean
C2348568 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0681814 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
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