ID

29570

Beskrivning

Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00378950

Länk

https://clinicaltrials.gov/show/NCT00378950

Nyckelord

Versioner (1)
  1. 2018-04-06 2018-04-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 april 2018

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00378950

Engelsk

Eligibility Heart Failure, Congestive NCT00378950

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of hf
Beskrivning

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
currently prescribed a loop diuretic medication
Beskrivning

Loop Diuretic prescribed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0354100
UMLS CUI [1,2]
C0278329
at least one of the following findings:
Beskrivning

Findings Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2607943
UMLS CUI [1,2]
C1550543
1. chest x-ray consistent with hf (current or past x-ray with probable or definite pulmonary edema)
Beskrivning

Chest X-ray Consistent with Heart failure | Pulmonary Edema Probable X-ray | Pulmonary Edema Definite X-ray

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0034063
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0034571
UMLS CUI [3,1]
C0034063
UMLS CUI [3,2]
C0439544
UMLS CUI [3,3]
C0034571
2. reduced ejection fraction on echocardiogram (echo), multiple gate acquisition scan (muga), or cardiac catheterization (less than 50%)
Beskrivning

Reduced ejection fraction Percentage Echocardiography | Reduced ejection fraction Percentage Multiple gated acquisition scanning | Reduced ejection fraction Percentage Cardiac Catheterization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4022792
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0013516
UMLS CUI [2,1]
C4022792
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0521317
UMLS CUI [3,1]
C4022792
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0018795
3. left ventricular hypertrophy (lvh) or diastolic filling pattern on echo
Beskrivning

Left Ventricular Hypertrophy | Other Coding Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0149721
UMLS CUI [2,1]
C3846158
UMLS CUI [2,2]
C0013516
4. elevated b-type natriuretic peptide
Beskrivning

Brain natriuretic peptide increased

Datatyp

boolean

Alias
UMLS CUI [1]
C1095988
currently experiencing new york heart association class ii-iv symptoms or has experienced these symptoms in the 6 months prior to study entry
Beskrivning

Symptoms New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
has a working telephone
Beskrivning

Working Telephone Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043227
UMLS CUI [1,2]
C0039457
UMLS CUI [1,3]
C0470187
speaks english or spanish
Beskrivning

Able to speak English Language | Able to speak Spanish Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0037750
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be ineligible if they meet one the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. sight - inability to see printed educational material well enough to utilize it
Beskrivning

Vision | Reading printed material Educational Limited | Education material Utilization Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0042789
UMLS CUI [2,1]
C1290980
UMLS CUI [2,2]
C0013622
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C4266536
UMLS CUI [3,2]
C0042153
UMLS CUI [3,3]
C1299582
2. cognition - moderate to severe dementia (if medical notes state "severe dementia" or as determined by administering the study's cognitive screener)
Beskrivning

Cognition | Moderate dementia | Severe dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0009240
UMLS CUI [2]
C3494871
UMLS CUI [3]
C3494652
3. surgery -valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
Beskrivning

Operative Surgical Procedures | Valvular disease Severe | Mitral Stenosis | Aortic Stenosis | Aortic regurgitation | Operative Surgical Procedures Valve Planned | Bypass | Angioplasty | Valve replacement | Heart Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0026269
UMLS CUI [4]
C0003507
UMLS CUI [5]
C0003504
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C1186983
UMLS CUI [6,3]
C1301732
UMLS CUI [7]
C0741847
UMLS CUI [8]
C0162577
UMLS CUI [9]
C1410969
UMLS CUI [10]
C0018823
4. terminal illness - possessing a terminal illness with prognosis of 1 year or less
Beskrivning

Terminal illness | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0023671
5. dialysis - currently on dialysis or anticipated to start dialysis within 1 year
Beskrivning

Dialysis | Initiation Dialysis Anticipated

Datatyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C3840775
6. oxygen dependant - using concentrate oxygen intermittent or continuously for copd
Beskrivning

Dependence on supplemental oxygen | Oxygen (intermittent or continuous) COPD

Datatyp

boolean

Alias
UMLS CUI [1]
C1135276
UMLS CUI [2,1]
C3845530
UMLS CUI [2,2]
C0024117
7. management of care - not able to control medications
Beskrivning

Care management | Pharmaceutical Preparations Control Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C2735310
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2587213
UMLS CUI [2,3]
C1299582
8. other studies -patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
Beskrivning

Study Subject Participation Status | Intervention Interferes with Research results

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
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Similar models

Eligibility Heart Failure, Congestive NCT00378950

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure
Item
clinical diagnosis of hf
boolean
C0018801 (UMLS CUI [1])
Loop Diuretic prescribed
Item
currently prescribed a loop diuretic medication
boolean
C0354100 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Findings Fulfill
Item
at least one of the following findings:
boolean
C2607943 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Chest X-ray Consistent with Heart failure | Pulmonary Edema Probable X-ray | Pulmonary Edema Definite X-ray
Item
1. chest x-ray consistent with hf (current or past x-ray with probable or definite pulmonary edema)
boolean
C0039985 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0034063 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0034063 (UMLS CUI [3,1])
C0439544 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
Reduced ejection fraction Percentage Echocardiography | Reduced ejection fraction Percentage Multiple gated acquisition scanning | Reduced ejection fraction Percentage Cardiac Catheterization
Item
2. reduced ejection fraction on echocardiogram (echo), multiple gate acquisition scan (muga), or cardiac catheterization (less than 50%)
boolean
C4022792 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C4022792 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
C4022792 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0018795 (UMLS CUI [3,3])
Left Ventricular Hypertrophy | Other Coding Echocardiography
Item
3. left ventricular hypertrophy (lvh) or diastolic filling pattern on echo
boolean
C0149721 (UMLS CUI [1])
C3846158 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Brain natriuretic peptide increased
Item
4. elevated b-type natriuretic peptide
boolean
C1095988 (UMLS CUI [1])
Symptoms New York Heart Association Classification
Item
currently experiencing new york heart association class ii-iv symptoms or has experienced these symptoms in the 6 months prior to study entry
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Working Telephone Available
Item
has a working telephone
boolean
C0043227 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Able to speak English Language | Able to speak Spanish Language
Item
speaks english or spanish
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be ineligible if they meet one the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Vision | Reading printed material Educational Limited | Education material Utilization Unable
Item
1. sight - inability to see printed educational material well enough to utilize it
boolean
C0042789 (UMLS CUI [1])
C1290980 (UMLS CUI [2,1])
C0013622 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C4266536 (UMLS CUI [3,1])
C0042153 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Cognition | Moderate dementia | Severe dementia
Item
2. cognition - moderate to severe dementia (if medical notes state "severe dementia" or as determined by administering the study's cognitive screener)
boolean
C0009240 (UMLS CUI [1])
C3494871 (UMLS CUI [2])
C3494652 (UMLS CUI [3])
Operative Surgical Procedures | Valvular disease Severe | Mitral Stenosis | Aortic Stenosis | Aortic regurgitation | Operative Surgical Procedures Valve Planned | Bypass | Angioplasty | Valve replacement | Heart Transplantation
Item
3. surgery -valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
boolean
C0543467 (UMLS CUI [1])
C3258293 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0026269 (UMLS CUI [3])
C0003507 (UMLS CUI [4])
C0003504 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C1186983 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
C0741847 (UMLS CUI [7])
C0162577 (UMLS CUI [8])
C1410969 (UMLS CUI [9])
C0018823 (UMLS CUI [10])
Terminal illness | Life Expectancy
Item
4. terminal illness - possessing a terminal illness with prognosis of 1 year or less
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Dialysis | Initiation Dialysis Anticipated
Item
5. dialysis - currently on dialysis or anticipated to start dialysis within 1 year
boolean
C0011946 (UMLS CUI [1])
C1704686 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Dependence on supplemental oxygen | Oxygen (intermittent or continuous) COPD
Item
6. oxygen dependant - using concentrate oxygen intermittent or continuously for copd
boolean
C1135276 (UMLS CUI [1])
C3845530 (UMLS CUI [2,1])
C0024117 (UMLS CUI [2,2])
Care management | Pharmaceutical Preparations Control Unable
Item
7. management of care - not able to control medications
boolean
C2735310 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Study Subject Participation Status | Intervention Interferes with Research results
Item
8. other studies -patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
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