ID

14581

Description

The Home INR Study; ODM derived from: https://clinicaltrials.gov/show/NCT00032591

Link

https://clinicaltrials.gov/show/NCT00032591

Keywords

Versions (1)
  1. 4/22/16 4/22/16 -
Uploaded on

April 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00032591

English

Eligibility Atrial Fibrillation NCT00032591

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have af and/or a mhv;
Description

Atrial Fibrillation | HEART-VALVE, MECHANICAL

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0493527
2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
Description

Warfarin Indefinite time

Data type

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0332187
3. be using warfarin according to the criteria described in the coumadin package insert (no off-label uses);
Description

Use of Warfarin | Coumadin Package Inserts

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0043031
UMLS CUI [2,1]
C0699129
UMLS CUI [2,2]
C0030174
4. be expected to survive for the duration of the study;
Description

Continuance of life Study duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0038952
UMLS CUI [1,2]
C0489652
5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the coumadin package insert;
Description

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2]
C0038525
UMLS CUI [3]
C0553692
6. be willing to perform pst;
Description

Patient Self Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0039593
7. be willing to be randomized;
Description

Randomization

Data type

boolean

Alias
UMLS CUI [1]
C0034656
8. possess adequate cognitive and language skills to follow the protocol and all related instructions;
Description

Compliance behavior | Skills relating to cognitive functions | language ability

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0589520
UMLS CUI [3]
C1145677
9. be willing to participate for the full duration of the study;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
10. sign the informed consent form; and
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
11. not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Description

Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1948041
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C1948041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
Description

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage | Medical contraindication

Data type

boolean

Alias
UMLS CUI [1]
C0151699
UMLS CUI [2]
C0038525
UMLS CUI [3]
C0553692
UMLS CUI [4]
C1301624
2. subject enrolled in another randomized clinical trial that involves a drug or device intervention
Description

Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1948041
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C1948041
3. subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
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Similar models

Eligibility Atrial Fibrillation NCT00032591

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation | HEART-VALVE, MECHANICAL
Item
1. have af and/or a mhv;
boolean
C0004238 (UMLS CUI [1])
C0493527 (UMLS CUI [2])
Warfarin Indefinite time
Item
2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
boolean
C0043031 (UMLS CUI [1,1])
C0332187 (UMLS CUI [1,2])
Use of Warfarin | Coumadin Package Inserts
Item
3. be using warfarin according to the criteria described in the coumadin package insert (no off-label uses);
boolean
C1524063 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2,1])
C0030174 (UMLS CUI [2,2])
Continuance of life Study duration
Item
4. be expected to survive for the duration of the study;
boolean
C0038952 (UMLS CUI [1,1])
C0489652 (UMLS CUI [1,2])
Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage
Item
5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the coumadin package insert;
boolean
C0151699 (UMLS CUI [1])
C0038525 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
Patient Self Testing
Item
6. be willing to perform pst;
boolean
C0030705 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Randomization
Item
7. be willing to be randomized;
boolean
C0034656 (UMLS CUI [1])
Compliance behavior | Skills relating to cognitive functions | language ability
Item
8. possess adequate cognitive and language skills to follow the protocol and all related instructions;
boolean
C1321605 (UMLS CUI [1])
C0589520 (UMLS CUI [2])
C1145677 (UMLS CUI [3])
Study Subject Participation Status
Item
9. be willing to participate for the full duration of the study;
boolean
C2348568 (UMLS CUI [1])
Informed Consent
Item
10. sign the informed consent form; and
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures
Item
11. not be enrolled in another randomized clinical trial that involves a drug or device intervention.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1948041 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C1948041 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage | Medical contraindication
Item
1. subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
boolean
C0151699 (UMLS CUI [1])
C0038525 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
C1301624 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures
Item
2. subject enrolled in another randomized clinical trial that involves a drug or device intervention
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1948041 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C1948041 (UMLS CUI [3,2])
Compliance behavior Limited
Item
3. subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
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