ID

39991

Beskrivning

Pilot Study of Home Blood Pressure Control Program; ODM derived from: https://clinicaltrials.gov/show/NCT01387945

Länk

https://clinicaltrials.gov/show/NCT01387945

Nyckelord

Versioner (1)
  1. 2020-03-08 2020-03-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT01387945

Engelsk

Eligibility Hypertension NCT01387945

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:
Beskrivning

Hypertensive disease | Increase in blood pressure | Blood Pressure Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0497247
UMLS CUI [3,1]
C0005823
UMLS CUI [3,2]
C0205318
average risk,
Beskrivning

Average Risk level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C2923839
sbp >140 mmhg or dbp > 90 mmhg;
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
vascular disease (cerebrovascular disease, coronary heart disease, diabetes mellitus, peripheral vascular disease, renal insufficiency)
Beskrivning

Vascular Disease | Cerebrovascular Disorder | Coronary heart disease | Diabetes Mellitus | Peripheral Vascular Diseases | Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0042373
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0010068
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0085096
UMLS CUI [6]
C1565489
sbp >130 mmhg or dbp >80 mmhg;
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
left ventricular dysfunction,
Beskrivning

Ventricular Dysfunction, Left

Datatyp

boolean

Alias
UMLS CUI [1]
C0242698
sbp 120 mmhg or dbp >80 mmhg;
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
can read and understand english; must have access to internet
Beskrivning

Able to read English Language | Comprehension English Language | Access Internet

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0444454
UMLS CUI [3,2]
C0282111
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to comply with protocol;
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
pregnancy;
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
secondary hypertension (e.g. renovascular);
Beskrivning

Secondary hypertension | Hypertension, Renovascular

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0020545
participation in other hypertension clinical trials;
Beskrivning

Study Subject Participation Status | Hypertension Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0008976
hospitalized in the past six months for diabetes, renal failure, or heart failure;
Beskrivning

Hospitalization Due to Diabetes Mellitus | Hospitalization Due to Kidney Failure | Hospitalization Due to Heart Failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0035078
UMLS CUI [3]
C3898876
severe renal insufficiency (estimated glomerular filtration rate < 30 ml/min);
Beskrivning

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
patient already routinely using a home blood pressure monitoring device or patient not able to use hbpm device due to disability;
Beskrivning

Use of Home Blood Pressure Monitoring Device | Home Blood Pressure Monitoring Unable | Etiology Disability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1449681
UMLS CUI [1,3]
C0025080
UMLS CUI [2,1]
C1449681
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0231170
arm circumference larger than 17 inches determined during telephone screener,
Beskrivning

Circumference of arm

Datatyp

boolean

Alias
UMLS CUI [1]
C2075184
arm circumference smaller than 9 inches measured at baseline research visit.
Beskrivning

Circumference of arm

Datatyp

boolean

Alias
UMLS CUI [1]
C2075184
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Similar models

Eligibility Hypertension NCT01387945

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Increase in blood pressure | Blood Pressure Uncontrolled
Item
diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:
boolean
C0020538 (UMLS CUI [1])
C0497247 (UMLS CUI [2])
C0005823 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Average Risk level
Item
average risk,
boolean
C1510992 (UMLS CUI [1,1])
C2923839 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
sbp >140 mmhg or dbp > 90 mmhg;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Vascular Disease | Cerebrovascular Disorder | Coronary heart disease | Diabetes Mellitus | Peripheral Vascular Diseases | Renal Insufficiency
Item
vascular disease (cerebrovascular disease, coronary heart disease, diabetes mellitus, peripheral vascular disease, renal insufficiency)
boolean
C0042373 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0010068 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
Systolic Pressure | Diastolic blood pressure
Item
sbp >130 mmhg or dbp >80 mmhg;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Ventricular Dysfunction, Left
Item
left ventricular dysfunction,
boolean
C0242698 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
sbp 120 mmhg or dbp >80 mmhg;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Able to read English Language | Comprehension English Language | Access Internet
Item
can read and understand english; must have access to internet
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0444454 (UMLS CUI [3,1])
C0282111 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance Unable
Item
unable to comply with protocol;
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Secondary hypertension | Hypertension, Renovascular
Item
secondary hypertension (e.g. renovascular);
boolean
C0155616 (UMLS CUI [1])
C0020545 (UMLS CUI [2])
Study Subject Participation Status | Hypertension Clinical Trial
Item
participation in other hypertension clinical trials;
boolean
C2348568 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Hospitalization Due to Diabetes Mellitus | Hospitalization Due to Kidney Failure | Hospitalization Due to Heart Failure
Item
hospitalized in the past six months for diabetes, renal failure, or heart failure;
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0035078 (UMLS CUI [2,3])
C3898876 (UMLS CUI [3])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal insufficiency (estimated glomerular filtration rate < 30 ml/min);
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Use of Home Blood Pressure Monitoring Device | Home Blood Pressure Monitoring Unable | Etiology Disability
Item
patient already routinely using a home blood pressure monitoring device or patient not able to use hbpm device due to disability;
boolean
C1524063 (UMLS CUI [1,1])
C1449681 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1449681 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0231170 (UMLS CUI [3,2])
Circumference of arm
Item
arm circumference larger than 17 inches determined during telephone screener,
boolean
C2075184 (UMLS CUI [1])
Circumference of arm
Item
arm circumference smaller than 9 inches measured at baseline research visit.
boolean
C2075184 (UMLS CUI [1])
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