ID

27426

Description

Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Patient visit (Z-form)

Link

https://www.clinicaltrials.gov/ct2/show/NCT01878630

Keywords

Versions (1)
  1. 11/14/17 11/14/17 -
Copyright Holder

Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin

Uploaded on

November 14, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630

German English ( localization.languageCode.US )

Patient visit

1 forms  
  1. StudyEvent: ODM
    1. Patient visit
Zwischenvisite
Description

Zwischenvisite

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0262926
UMLS CUI-3
C1512346
UMLS CUI-4
C0018801
UMLS CUI-5
C0162648
Center-ID
Description

Center-ID

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Stud-PID
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Zeitpunkt Zwischenvisite
Description

timepoint patient visit

Data type

integer

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C2348792
Termin nächste Studienvisite:
Description

next patient visit appointment date

Data type

date

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0585085
Angaben auf Z-Bogen vom Prüfarzt bestätigt am:
Description

Investigator's signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name (Prüfarzt)
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift (Prüfarzt)
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Körperliche Untersuchung / Anamnese
Description

Körperliche Untersuchung / Anamnese

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0262926
UMLS CUI-3
C1512346
UMLS CUI-4
C0444496
UMLS CUI-5
C0587453
Gewicht
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blutdruck, systolisch
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blutdruck, diastolisch
Description

diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Symptome und Zeichen der Herzinsuffizienz
Description

Symptome und Zeichen der Herzinsuffizienz

Alias
UMLS CUI-1
C0018801
UMLS CUI-2
C0037088
NYHA-Klasse
Description

NYHA class

Data type

integer

Alias
UMLS CUI [1]
C1882083
Belastungsdyspnoe?
Description

exertional dyspnea

Data type

integer

Alias
UMLS CUI [1]
C0231807
Ruhedyspnoe
Description

dyspnea at rest

Data type

integer

Alias
UMLS CUI [1]
C0743330
Periphere Ödeme
Description

peripheral edema

Data type

integer

Alias
UMLS CUI [1]
C0085649
Halsvenenstauung
Description

engorgement of the neck veins

Data type

integer

Alias
UMLS CUI [1]
C0425687
Pulmonale Rasselgeräusche
Description

pulmonary rales

Data type

integer

Alias
UMLS CUI [1,1]
C0034642
UMLS CUI [1,2]
C2709248
UMLS CUI [1,3]
C0004339
EKG
Description

EKG

Alias
UMLS CUI-1
C1623258
Herzfrequenz
Description

heart rate

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1623258
/min
Rhythmus
Description

rhythm

Data type

integer

Alias
UMLS CUI [1,1]
C0232187
UMLS CUI [1,2]
C1623258
Schrittmacher-Rhythmus?
Description

paced rhythm

Data type

boolean

Alias
UMLS CUI [1,1]
C2981711
UMLS CUI [1,2]
C1623258
AV-Block?
Description

Atrioventricular Block

Data type

integer

Alias
UMLS CUI [1,1]
C0004245
UMLS CUI [1,2]
C1623258
Linksschenkelblock?
Description

Left Bundle-Branch Block

Data type

boolean

Alias
UMLS CUI [1,1]
C0023211
UMLS CUI [1,2]
C1623258
Auffälligkeiten EKG:
Description

ECG abnormalities

Data type

text

Alias
UMLS CUI [1]
C0522055
Medizinische Versorgung seit der letzten Studienvisite
Description

Medizinische Versorgung seit der letzten Studienvisite

Alias
UMLS CUI-1
C1704738
UMLS CUI-2
C1512346
Medizinische Versorgung erfolgt?
Description

Falls ja, bitte in die folgende Tabelle eintragen

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0018704
Kategorie (der Versorgung), bitte auswählen
Description

Type of health care provided

Data type

integer

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0086388
UMLS CUI [1,3]
C0332307
Datum der Versorgung
Description

date health care was provided

Data type

partialDate

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0086388
UMLS CUI [1,3]
C0011008
Wo erfolgte die Versorgung?
Description

location health care was provided

Data type

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0018704
UMLS CUI [1,3]
C0450429
Grund
Description

reason for patient visit

Data type

text

Alias
UMLS CUI [1,1]
C1704447
UMLS CUI [1,2]
C0018704
Labordiagnostik (Blut)
Description

Labordiagnostik (Blut)

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Datum der Blutentnahme
Description

date of blood sample collection

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hämoglobin
Description

mmol/l oder g/dl

Data type

float

Alias
UMLS CUI [1]
C0019046
Hämatokrit
Description

hematocrit

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0518014
%
Leukozyten
Description

Leucocytes

Data type

float

Measurement units
  • /ul
Alias
UMLS CUI [1]
C0023508
/ul
Thrombozyten
Description

Thrombocytes

Data type

float

Measurement units
  • /ul
Alias
UMLS CUI [1]
C0005821
/ul
Kreatinin (Serum)
Description

umol/l oder mg/dl

Data type

float

Alias
UMLS CUI [1]
C0201976
Natrium
Description

Sodium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Kalium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Blutprobe für kardiale Biomarker abgenommen und versandt?
Description

blood sample for cardiac markers

Data type

boolean

Alias
UMLS CUI [1,1]
C1271630
UMLS CUI [1,2]
C0005834
Aktuelle Medikation
Description

Aktuelle Medikation

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1553892
Aktuelle Medikation:
Description

current medication

Data type

integer

Alias
UMLS CUI [1]
C0013227
Falls ja, Wirkstoff/Medikament?
Description

active substance/medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C1254351
Einzeldosis: früh
Description

dosage morning

Data type

float

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332170
Einzeldosis: mittags
Description

dosage noon

Data type

float

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0585020
Einzeldosis: abends
Description

dosage evening

Data type

float

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
Einzeldosis: spät
Description

dosage evening

Data type

float

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0587117
Dosis Einheit
Description

medication unit

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
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Similar models

Patient visit

1 forms
  1. StudyEvent: ODM
    1. Patient visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Zwischenvisite
C0031809 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1512346 (UMLS CUI-3)
C0018801 (UMLS CUI-4)
C0162648 (UMLS CUI-5)
Center-ID
Item
Center-ID
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient ID
Item
Stud-PID
integer
C2348585 (UMLS CUI [1])
Item
Zeitpunkt Zwischenvisite
integer
C1512346 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
timepoint patient visit
Code List
Zeitpunkt Zwischenvisite
CL Item
Visite nach 3 Monaten (1)
CL Item
Visite nach 6 Monaten (2)
CL Item
Visite nach 9 Monaten (3)
next patient visit appointment date
Item
Termin nächste Studienvisite:
date
C1512346 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0585085 (UMLS CUI [1,3])
Investigator's signature date
Item
Angaben auf Z-Bogen vom Prüfarzt bestätigt am:
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Name (Prüfarzt)
text
C2826892 (UMLS CUI [1])
Investigator's signature
Item
Unterschrift (Prüfarzt)
text
C2346576 (UMLS CUI [1])
Item Group
Körperliche Untersuchung / Anamnese
C0031809 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1512346 (UMLS CUI-3)
C0444496 (UMLS CUI-4)
C0587453 (UMLS CUI-5)
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
systolic blood pressure
Item
Blutdruck, systolisch
integer
C0871470 (UMLS CUI [1])
diastolic blood pressure
Item
Blutdruck, diastolisch
integer
C0428883 (UMLS CUI [1])
Item Group
Symptome und Zeichen der Herzinsuffizienz
C0018801 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
Item
NYHA-Klasse
integer
C1882083 (UMLS CUI [1])
NYHA class
Code List
NYHA-Klasse
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Item
Belastungsdyspnoe?
integer
C0231807 (UMLS CUI [1])
exertional dyspnea
Code List
Belastungsdyspnoe?
CL Item
ja (1)
CL Item
nein (2)
CL Item
unbekannt (3)
Item
Ruhedyspnoe
integer
C0743330 (UMLS CUI [1])
exertional dyspnea
Code List
Ruhedyspnoe
CL Item
ja (1)
CL Item
nein (2)
CL Item
unbekannt (3)
Item
Periphere Ödeme
integer
C0085649 (UMLS CUI [1])
exertional dyspnea
Code List
Periphere Ödeme
CL Item
ja (1)
CL Item
nein (2)
CL Item
unbekannt (3)
Item
Halsvenenstauung
integer
C0425687 (UMLS CUI [1])
exertional dyspnea
Code List
Halsvenenstauung
CL Item
ja (1)
CL Item
nein (2)
CL Item
unbekannt (3)
Item
Pulmonale Rasselgeräusche
integer
C0034642 (UMLS CUI [1,1])
C2709248 (UMLS CUI [1,2])
C0004339 (UMLS CUI [1,3])
exertional dyspnea
Code List
Pulmonale Rasselgeräusche
CL Item
ja (1)
CL Item
nein (2)
CL Item
unbekannt (3)
Item Group
EKG
C1623258 (UMLS CUI-1)
heart rate
Item
Herzfrequenz
integer
C0018810 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Item
Rhythmus
integer
C0232187 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
rhythm
Code List
Rhythmus
CL Item
Sinus (1)
CL Item
Vorhofflimmern (2)
CL Item
anderer (3)
paced rhythm
Item
Schrittmacher-Rhythmus?
boolean
C2981711 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Item
AV-Block?
integer
C0004245 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Atrioventricular Block
Code List
AV-Block?
CL Item
nein (1)
CL Item
Grad 1 (2)
CL Item
Grad 2 (3)
CL Item
Grad 3 (4)
Left Bundle-Branch Block
Item
Linksschenkelblock?
boolean
C0023211 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
ECG abnormalities
Item
Auffälligkeiten EKG:
text
C0522055 (UMLS CUI [1])
Item Group
Medizinische Versorgung seit der letzten Studienvisite
C1704738 (UMLS CUI-1)
C1512346 (UMLS CUI-2)
Utilisation of health care resources
Item
Medizinische Versorgung erfolgt?
boolean
C1512346 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Item
Kategorie (der Versorgung), bitte auswählen
integer
C1512346 (UMLS CUI [1,1])
C0086388 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Type of health care provided
Code List
Kategorie (der Versorgung), bitte auswählen
CL Item
Hausarztbesuch mit Arztkontakt (1)
CL Item
Kardiologenbesuch mit Arztkontakt (2)
CL Item
Rehabilitationsaufenthalt (3)
CL Item
Krankenhausaufenthalt mit Datumswechsel (4)
CL Item
Notfallversorgung (5)
date health care was provided
Item
Datum der Versorgung
partialDate
C1512346 (UMLS CUI [1,1])
C0086388 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
location health care was provided
Item
Wo erfolgte die Versorgung?
text
C1512346 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
reason for patient visit
Item
Grund
text
C1704447 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Item Group
Labordiagnostik (Blut)
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
date of blood sample collection
Item
Datum der Blutentnahme
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hemoglobin
Item
Hämoglobin
float
C0019046 (UMLS CUI [1])
hematocrit
Item
Hämatokrit
integer
C0518014 (UMLS CUI [1])
Leucocytes
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Thrombocytes
Item
Thrombozyten
float
C0005821 (UMLS CUI [1])
Serum Creatinine
Item
Kreatinin (Serum)
float
C0201976 (UMLS CUI [1])
Sodium
Item
Natrium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Kalium
float
C0202194 (UMLS CUI [1])
blood sample for cardiac markers
Item
Blutprobe für kardiale Biomarker abgenommen und versandt?
boolean
C1271630 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
Aktuelle Medikation
C0013227 (UMLS CUI-1)
C1553892 (UMLS CUI-2)
Item
Aktuelle Medikation:
integer
C0013227 (UMLS CUI [1])
current medication
Code List
Aktuelle Medikation:
CL Item
ACE-Hemmer (1)
CL Item
AT1-Rezeptorantagonist (2)
CL Item
beta-Blocker (3)
CL Item
Thiazid (4)
CL Item
Schleifendiuretikum (5)
CL Item
anderes Diuretikum (6)
CL Item
Aldosteron-Antagonist (7)
CL Item
Herzglykosid (8)
CL Item
Antiarrhthmikum (9)
CL Item
Ca-Antagonist (10)
CL Item
Nitrat (11)
CL Item
Ivabradin (12)
CL Item
Statin (13)
CL Item
ASS (14)
CL Item
andere Plättchenhemmer (15)
CL Item
Vitamin-K-Antagonist (16)
CL Item
anderes Antikoagulanz (17)
CL Item
Orales Antidiabetikum (18)
CL Item
Insulin (19)
CL Item
Weitere Medikamente u./o. Bedarfsmedikation (20)
active substance/medication name
Item
Falls ja, Wirkstoff/Medikament?
text
C2360065 (UMLS CUI [1])
C1254351 (UMLS CUI [2])
dosage morning
Item
Einzeldosis: früh
float
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
dosage noon
Item
Einzeldosis: mittags
float
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
dosage evening
Item
Einzeldosis: abends
float
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
dosage evening
Item
Einzeldosis: spät
float
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
medication unit
Item
Dosis Einheit
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
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