ID

13741

Beskrivning

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Nyckelord

Versioner (1)
  1. 2016-03-02 2016-03-02 -
Uppladdad den

2 mars 2016

DOI

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Creative Commons BY-NC 3.0
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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

Engelsk

CABACS Case Report Form [neurological examination:day 30]

1 Formulär  
Modified Rankin Scale,structured interview
Beskrivning

Modified Rankin Scale,structured interview

Patient ID
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Do you (your family member) need constant nursing care?
Beskrivning

Constant nursing care

Datatyp

integer

Alias
UMLS CUI [1]
C0204650
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
Beskrivning

Assistance ADL needed

Datatyp

integer

Alias
UMLS CUI [1]
C2599638
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
Beskrivning

Home maintenance assistance

Datatyp

text

Alias
UMLS CUI [1]
C0150250
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
Beskrivning

Change in social life

Datatyp

text

Alias
UMLS CUI [1,1]
C0815198
UMLS CUI [1,2]
C0392747
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
Beskrivning

Neurologic Symptoms

Datatyp

text

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0497297
No disability at all
Beskrivning

Disability

Datatyp

boolean

Alias
UMLS CUI [1]
C0231170
DemTect B
Beskrivning

DemTect B

Date of visit
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Patient ID
Beskrivning

Patient Study ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Patient age
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI [1]
C0001779
Did you perform the DemTect test with the patient?
Beskrivning

Psychometric testing for dementia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Count of correctly repeated words of wordlist:grass,butter,stone,child,shack,whistle,plank,horse,earth,nail
Beskrivning

See instruction for DemTect testing and converting table in your investigator file Please read the list to the patient, let him/her repeat and count correctly repeated words. Then read it to the patient a second time and let him/her repeat again. Add the count of correctly repeated to the first count

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Converting numbers: Count of correctly converted numbers 308= ;6032= ; fourhundredtwentythree= ; eightthousandfiftyseven=
Beskrivning

I.e 4=four or two=2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please count the number of animals your patient can think of within one minute
Beskrivning

Psychometric testing for dementia

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
Beskrivning

First attempt:5-3 ; 2-7-9; 4-1-9-8; 3-6-4-2-8; 3-1-7-9-4-2 Second attempt: 7-4; 5-4-8; 8-9-6-1; 5-7-8-2-9; 6-1-4-8-5-2

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
Beskrivning

Psychometric testing for dementia

Datatyp

integer

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
Beskrivning

Psychometric testing for dementia

Datatyp

text

Alias
UMLS CUI [1,1]
C0033920
UMLS CUI [1,2]
C0497327
Date of completion of this form
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beskrivning

Name of Investigator

Datatyp

text

Alias
UMLS CUI [1]
C0008961
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Similar models

CABACS Case Report Form [neurological examination:day 30]

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Modified Rankin Scale,structured interview
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item
Do you (your family member) need constant nursing care?
integer
C0204650 (UMLS CUI [1])
Constant nursing care
Code List
Do you (your family member) need constant nursing care?
CL Item
yes (severe disability,bedridden,incontinence,constant nursing care in almost every aspect of daily life)  (1)
CL Item
No (2)
Item
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
integer
C2599638 (UMLS CUI [1])
Assistance ADL needed
Code List
Do you (your family member)need assistance with eating,toileting,personal hygiene or walking?
CL Item
Yes (moderately severe disability, walking without help impossible,assistance with ADL´s needed)  (1)
CL Item
No (2)
Item
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
text
C0150250 (UMLS CUI [1])
Home maintenance assistance
Code List
Do you (your family member) need assistance to prepare a simple meal, for house keeping tasks, deal with money, do the groceries or to get along in your home town?
CL Item
Yes (Moderate disability, assistance needed but can walk with or without walking aid)  (1)
CL Item
No (2)
Item
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
text
C0815198 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Change in social life
Code List
Have there been changes in your (your family members) ability to work or care for others if that´s what you did? Have there been changes in your (your family members) ability to participate in social and leisure activities? Have you (your family member) experienced problems with personal relationships or did you (your family member) seclude yourself?
CL Item
Yes (mild disability, not all former activities can be performed but independend life without help is still possible)  (1)
CL Item
No (2)
Item
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
text
C0235031 (UMLS CUI [1,1])
C0497297 (UMLS CUI [1,2])
Neurologic Symptoms
Code List
Do you (your family member) have problems with reading or writing or to find the right words during conversation? Have you (your family member) experienced problems with balance, coordination, vision, numbness of diverse skin spots or problems to swallow?
CL Item
Yes (no significant disability, despite symptoms all daily activities can be performed independently)  (1)
CL Item
No (2)
Disability
Item
No disability at all
boolean
C0231170 (UMLS CUI [1])
Item Group
DemTect B
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
Psychometric testing for dementia
Item
Did you perform the DemTect test with the patient?
boolean
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Count of correctly repeated words of wordlist:grass,butter,stone,child,shack,whistle,plank,horse,earth,nail
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Converting numbers: Count of correctly converted numbers 308= ;6032= ; fourhundredtwentythree= ; eightthousandfiftyseven=
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please count the number of animals your patient can think of within one minute
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note the longest line of numbers (max. 6 numbers in a row) your patient was able to repeat backwards. Two attempts allowed.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please ask your patient to repeat again the ten words of the first question and count the correctly repeated words.
integer
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Psychometric testing for dementia
Item
Please note any particularities regarding the testing situation (i.e patient with hearing impairment, any interruption during testing...)
text
C0033920 (UMLS CUI [1,1])
C0497327 (UMLS CUI [1,2])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
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