ID

29570

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00378950

Palavras-chave

  1. 06/04/2018 06/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Heart Failure, Congestive NCT00378950

Eligibility Heart Failure, Congestive NCT00378950

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of hf
Descrição

Heart failure

Tipo de dados

boolean

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

Loop Diuretic prescribed

Tipo de dados

boolean

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

Findings Fulfill

Tipo de dados

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)
Descrição

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

Tipo de dados

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%)
Descrição

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

Tipo de dados

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
Descrição

Left Ventricular Hypertrophy | Other Coding Echocardiography

Tipo de dados

boolean

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

Brain natriuretic peptide increased

Tipo de dados

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
Descrição

Symptoms New York Heart Association Classification

Tipo de dados

boolean

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

Working Telephone Available

Tipo de dados

boolean

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

Able to speak English Language | Able to speak Spanish Language

Tipo de dados

boolean

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

Exclusion Criteria

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

Criteria Fulfill

Tipo de dados

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
Descrição

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

Tipo de dados

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)
Descrição

Cognition | Moderate dementia | Severe dementia

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Terminal illness | Life Expectancy

Tipo de dados

boolean

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

Dialysis | Initiation Dialysis Anticipated

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Care management | Pharmaceutical Preparations Control Unable

Tipo de dados

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
Descrição

Study Subject Participation Status | Intervention Interferes with Research results

Tipo de dados

boolean

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

Similar models

Eligibility Heart Failure, Congestive NCT00378950

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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