ID

40867

Beschreibung

Geriatric Out of Hospital Randomized Meal Trial in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02148679

Link

https://clinicaltrials.gov/show/NCT02148679

Stichworte

Versionen (1)
  1. 28.05.20 28.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Mai 2020

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.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

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

Eligibility Heart Failure NCT02148679

Englisch

Eligibility Heart Failure NCT02148679

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
60 male and female patients aged ≥ 65 years with history of systemic hypertension and acutely decompensated heart failure (adhf; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). adhf will be confirmed by the study physician and defined as a combination of symptoms, signs, and hf-specific medical treatments. specifically, adhf will require that all four of the following conditions are met:
Beschreibung

Age | Hypertensive disease | ADHF Principal diagnosis | ADHF Secondary diagnosis | Symptoms Heart failure | Signs Heart failure | Therapy Specific Heart failure | Criteria All Fulfill

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
UMLS CUI [3,1]
C1609524
UMLS CUI [3,2]
C0332137
UMLS CUI [4,1]
C1609524
UMLS CUI [4,2]
C0332138
UMLS CUI [5,1]
C1457887
UMLS CUI [5,2]
C0018801
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C0018801
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0205369
UMLS CUI [7,3]
C0018801
UMLS CUI [8,1]
C0243161
UMLS CUI [8,2]
C0444868
UMLS CUI [8,3]
C1550543
≥1 symptom of hf (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
Beschreibung

Symptoms Quantity Heart failure | Dyspnea | Fatigue | Orthopnea | Paroxysmal nocturnal dyspnea | Worsening Symptoms Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0013404
UMLS CUI [3]
C0015672
UMLS CUI [4]
C0085619
UMLS CUI [5]
C1956415
UMLS CUI [6,1]
C0332271
UMLS CUI [6,2]
C1457887
UMLS CUI [6,3]
C0018801
≥ 2 signs of hf (pulmonary congestion on exam and/or chest x-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased b-type natriuretic peptide (bnp; ≥100 pg/ml)
Beschreibung

Signs Quantity Heart failure | Pulmonary congestion Examination | Pulmonary congestion Chest X-ray | Raised jugular venous pressure | Peripheral edema | Weight Gain Rapid | Brain natriuretic peptide increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0242073
UMLS CUI [2,2]
C0582103
UMLS CUI [3,1]
C0242073
UMLS CUI [3,2]
C0039985
UMLS CUI [4]
C0520861
UMLS CUI [5]
C0085649
UMLS CUI [6,1]
C0043094
UMLS CUI [6,2]
C0456962
UMLS CUI [7]
C1095988
change in medical treatment specifically targeting hf (diuretics, vasodilators, and/or neurohormonal modulating agents)
Beschreibung

Treatment changed | Targeted Therapy Heart failure | Diuretics | Vasodilator Agents | Neurohormone Modulation Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2919691
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0018801
UMLS CUI [3]
C0012798
UMLS CUI [4]
C0042402
UMLS CUI [5,1]
C0597049
UMLS CUI [5,2]
C0443264
UMLS CUI [5,3]
C1254351
no other cause of the patient's symptoms and signs is apparent
Beschreibung

Symptoms Without Cause Other | Signs Without Cause Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0205394
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
systolic bp <100 mmhg at any time during hospitalization
Beschreibung

Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
use of inotropic therapy, severe valvular heart disease as the primary etiology of the patient's hf syndrome
Beschreibung

Inotropic agent | Heart valve disease Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0304509
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C0205082
uncontrolled hypertension (systolic bp >180 mmhg or diastolic bp >100 mmhg) or systolic bp <110 on discharge
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Systolic Pressure Hospital Discharge

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0586003
serum potassium >5.0 mmol/l during hospitalization or history of serum potassium >6.0 mmol/l
Beschreibung

Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0302353
severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2 at discharge)
Beschreibung

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
severe anemia (hemoglobin < 9 gm/dl)
Beschreibung

Anemia, severe | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518015
length of stay <48 hours or >14 days
Beschreibung

Length of Stay Hours | Length of Stay Days

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023303
UMLS CUI [1,2]
C0439227
UMLS CUI [2,1]
C0023303
UMLS CUI [2,2]
C0439228
co-morbidity with expected survival < 12 months
Beschreibung

Comorbidity | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
active alcohol or substance abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
history of persistent noncompliance with treatment recommendations as judged by the investigators
Beschreibung

Treatment Compliance Lacking Persistent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0205322
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Heart Failure NCT02148679

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease | ADHF Principal diagnosis | ADHF Secondary diagnosis | Symptoms Heart failure | Signs Heart failure | Therapy Specific Heart failure | Criteria All Fulfill
Item
60 male and female patients aged ≥ 65 years with history of systemic hypertension and acutely decompensated heart failure (adhf; primary diagnosis for admission or secondary diagnosis after hospitalization for another reason). adhf will be confirmed by the study physician and defined as a combination of symptoms, signs, and hf-specific medical treatments. specifically, adhf will require that all four of the following conditions are met:
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C1609524 (UMLS CUI [3,1])
C0332137 (UMLS CUI [3,2])
C1609524 (UMLS CUI [4,1])
C0332138 (UMLS CUI [4,2])
C1457887 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C0311392 (UMLS CUI [6,1])
C0018801 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0205369 (UMLS CUI [7,2])
C0018801 (UMLS CUI [7,3])
C0243161 (UMLS CUI [8,1])
C0444868 (UMLS CUI [8,2])
C1550543 (UMLS CUI [8,3])
Symptoms Quantity Heart failure | Dyspnea | Fatigue | Orthopnea | Paroxysmal nocturnal dyspnea | Worsening Symptoms Heart failure
Item
≥1 symptom of hf (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea) has worsened from baseline
boolean
C1457887 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2])
C0015672 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C1956415 (UMLS CUI [5])
C0332271 (UMLS CUI [6,1])
C1457887 (UMLS CUI [6,2])
C0018801 (UMLS CUI [6,3])
Signs Quantity Heart failure | Pulmonary congestion Examination | Pulmonary congestion Chest X-ray | Raised jugular venous pressure | Peripheral edema | Weight Gain Rapid | Brain natriuretic peptide increased
Item
≥ 2 signs of hf (pulmonary congestion on exam and/or chest x-ray, elevated jugular venous pressure, peripheral edema or rapid weight gain, and/or increased b-type natriuretic peptide (bnp; ≥100 pg/ml)
boolean
C0311392 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0242073 (UMLS CUI [2,1])
C0582103 (UMLS CUI [2,2])
C0242073 (UMLS CUI [3,1])
C0039985 (UMLS CUI [3,2])
C0520861 (UMLS CUI [4])
C0085649 (UMLS CUI [5])
C0043094 (UMLS CUI [6,1])
C0456962 (UMLS CUI [6,2])
C1095988 (UMLS CUI [7])
Treatment changed | Targeted Therapy Heart failure | Diuretics | Vasodilator Agents | Neurohormone Modulation Agent
Item
change in medical treatment specifically targeting hf (diuretics, vasodilators, and/or neurohormonal modulating agents)
boolean
C2919691 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3])
C0042402 (UMLS CUI [4])
C0597049 (UMLS CUI [5,1])
C0443264 (UMLS CUI [5,2])
C1254351 (UMLS CUI [5,3])
Symptoms Without Cause Other | Signs Without Cause Other
Item
no other cause of the patient's symptoms and signs is apparent
boolean
C1457887 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0311392 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure
Item
systolic bp <100 mmhg at any time during hospitalization
boolean
C0871470 (UMLS CUI [1])
Inotropic agent | Heart valve disease Severe
Item
use of inotropic therapy, severe valvular heart disease as the primary etiology of the patient's hf syndrome
boolean
C0304509 (UMLS CUI [1])
C0018824 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Systolic Pressure Hospital Discharge
Item
uncontrolled hypertension (systolic bp >180 mmhg or diastolic bp >100 mmhg) or systolic bp <110 on discharge
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0871470 (UMLS CUI [4,1])
C0586003 (UMLS CUI [4,2])
Serum potassium measurement
Item
serum potassium >5.0 mmol/l during hospitalization or history of serum potassium >6.0 mmol/l
boolean
C0302353 (UMLS CUI [1])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2 at discharge)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Anemia, severe | Hemoglobin measurement
Item
severe anemia (hemoglobin < 9 gm/dl)
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Length of Stay Hours | Length of Stay Days
Item
length of stay <48 hours or >14 days
boolean
C0023303 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C0023303 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
Comorbidity | Life Expectancy
Item
co-morbidity with expected survival < 12 months
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Substance Use Disorders
Item
active alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
Treatment Compliance Lacking Persistent
Item
history of persistent noncompliance with treatment recommendations as judged by the investigators
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

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