ID

14581

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00032591

Stichworte

  1. 22.04.16 22.04.16 -
Hochgeladen am

22. April 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Atrial Fibrillation NCT00032591

Eligibility Atrial Fibrillation NCT00032591

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Atrial Fibrillation | HEART-VALVE, MECHANICAL

Datentyp

boolean

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

Warfarin Indefinite time

Datentyp

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);
Beschreibung

Use of Warfarin | Coumadin Package Inserts

Datentyp

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;
Beschreibung

Continuance of life Study duration

Datentyp

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;
Beschreibung

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage

Datentyp

boolean

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

Patient Self Testing

Datentyp

boolean

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

Randomization

Datentyp

boolean

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

Compliance behavior | Skills relating to cognitive functions | language ability

Datentyp

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;
Beschreibung

Study Subject Participation Status

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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
Beschreibung

Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage | Medical contraindication

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Compliance behavior Limited

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00032591

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video