ID

14581

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00032591

Trefwoorden

Versies (1)
  1. 22-04-16 22-04-16 -
Geüploaded op

22 april 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Atrial Fibrillation NCT00032591

Engels

Eligibility Atrial Fibrillation NCT00032591

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Atrial Fibrillation | HEART-VALVE, MECHANICAL

Datatype

boolean

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

Warfarin Indefinite time

Datatype

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);
Beschrijving

Use of Warfarin | Coumadin Package Inserts

Datatype

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;
Beschrijving

Continuance of life Study duration

Datatype

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;
Beschrijving

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage

Datatype

boolean

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

Patient Self Testing

Datatype

boolean

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

Randomization

Datatype

boolean

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

Compliance behavior | Skills relating to cognitive functions | language ability

Datatype

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;
Beschrijving

Study Subject Participation Status

Datatype

boolean

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

Informed Consent

Datatype

boolean

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

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

Datatype

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
Beschrijving

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
Beschrijving

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage | Medical contraindication

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Terug naar het begin van de pagina

Similar models

Eligibility Atrial Fibrillation NCT00032591

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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