ID

39464

Beskrivning

Exploring Behavioral Interventions to Improve Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01625819

Länk

https://clinicaltrials.gov/show/NCT01625819

Nyckelord

Versioner (1)
  1. 2020-01-13 2020-01-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01625819

Engelsk

Eligibility Heart Failure NCT01625819

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to perform a 6-minute walk task, with or without use of a cane or walker (must use the same walking assistance device during each session), and walk under 500 meters during task.
Beskrivning

Ability Perform 6-Minute Walk Test | Cane user | Independent of Cane | Walker user | Independent of Walker | 6-Minute Walk Test Distance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0430515
UMLS CUI [2]
C0920240
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0006856
UMLS CUI [4]
C0920121
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0043016
UMLS CUI [6,1]
C0430515
UMLS CUI [6,2]
C0012751
2. symptoms of chronic heart failure for at least 3 months.
Beskrivning

Symptoms Chronic heart failure Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0264716
UMLS CUI [1,3]
C0449238
3. clinically stable- defined as not having been hospitalized for a 3 month period, on stable doses of neurohormonal blocking agents and diuretics for at least 3 months.
Beskrivning

Stable status Clinical | Hospitalization Absent | Neurohormone antagonists Dose Stable | Diuretics Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0597049
UMLS CUI [3,2]
C0243076
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
4. acc/aha stages b and c
Beskrivning

ACC-AHA Heart failure Classification Stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4072694
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0008902
UMLS CUI [1,4]
C1306673
5. ability to perform light to moderate exercise (nyha functional class ii and iii)
Beskrivning

Ability Perform Light Exercise | Ability Perform Moderate Exercise | New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C1517883
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0884358
UMLS CUI [2,3]
C1513375
UMLS CUI [3]
C1275491
6. presence of hf with an ejection fraction less than 40%, or diastolic dysfunction
Beskrivning

Heart failure | Cardiac ejection fraction | Diastolic dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0232174
UMLS CUI [3]
C0520863
7. ability to give informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
8. at least18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of recent myocardial infarction (1 month)
Beskrivning

Recent myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1998297
2. angina not adequately managed with nitrates.
Beskrivning

Angina Pectoris | Nitrates Disease Management Inadequate

Datatyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0028125
UMLS CUI [2,2]
C0376636
UMLS CUI [2,3]
C0205412
3. aortic or mitral stenosis
Beskrivning

Aortic Valve Stenosis | Mitral Valve Stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2]
C0026269
4. coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
Beskrivning

Coronary revascularisation | Mitral valvuloplasty | Cardiac Surgery | Biventricular pacemaker insertion

Datatyp

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C0396849
UMLS CUI [3]
C0018821
UMLS CUI [4]
C3805138
5. severe copd
Beskrivning

Severe chronic obstructive pulmonary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0730607
6. recent stroke or significant cerebral neurologic impairment.
Beskrivning

Cerebrovascular accident | Neurologic Deficits cerebral

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0521654
UMLS CUI [2,2]
C0006104
7. active suicidality
Beskrivning

Suicidality

Datatyp

boolean

Alias
UMLS CUI [1]
C3166387
8. currently participating in an exercise program.
Beskrivning

Participation Exercise Program

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C3484370
9. currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
Beskrivning

Mood Stabilizer | Lithium | Benzodiazepines | Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0023870
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0040615
10. medications (steroids) and medical conditions affecting immune status not limited to grave's disease, rheumatoid arthritis, hashimoto's disease, sjogren's disease, lupus, multiple sclerosis
Beskrivning

Pharmaceutical Preparations Affecting Immunity | Steroids Affecting Immunity | Medical condition Affecting Immunity | Graves Disease | Rheumatoid Arthritis | Hashimoto Disease | Sjogren's Syndrome | Lupus Erythematosus | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0020964
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0020964
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0020964
UMLS CUI [4]
C0018213
UMLS CUI [5]
C0003873
UMLS CUI [6]
C0677607
UMLS CUI [7]
C1527336
UMLS CUI [8]
C0409974
UMLS CUI [9]
C0026769
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Similar models

Eligibility Heart Failure NCT01625819

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Ability Perform 6-Minute Walk Test | Cane user | Independent of Cane | Walker user | Independent of Walker | 6-Minute Walk Test Distance
Item
1. ability to perform a 6-minute walk task, with or without use of a cane or walker (must use the same walking assistance device during each session), and walk under 500 meters during task.
boolean
C0085732 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0430515 (UMLS CUI [1,3])
C0920240 (UMLS CUI [2])
C0332291 (UMLS CUI [3,1])
C0006856 (UMLS CUI [3,2])
C0920121 (UMLS CUI [4])
C0332291 (UMLS CUI [5,1])
C0043016 (UMLS CUI [5,2])
C0430515 (UMLS CUI [6,1])
C0012751 (UMLS CUI [6,2])
Symptoms Chronic heart failure Duration
Item
2. symptoms of chronic heart failure for at least 3 months.
boolean
C1457887 (UMLS CUI [1,1])
C0264716 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Stable status Clinical | Hospitalization Absent | Neurohormone antagonists Dose Stable | Diuretics Dose Stable
Item
3. clinically stable- defined as not having been hospitalized for a 3 month period, on stable doses of neurohormonal blocking agents and diuretics for at least 3 months.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0597049 (UMLS CUI [3,1])
C0243076 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0012798 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
ACC-AHA Heart failure Classification Stage
Item
4. acc/aha stages b and c
boolean
C4072694 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C1306673 (UMLS CUI [1,4])
Ability Perform Light Exercise | Ability Perform Moderate Exercise | New York Heart Association Classification
Item
5. ability to perform light to moderate exercise (nyha functional class ii and iii)
boolean
C0085732 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1517883 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C0884358 (UMLS CUI [2,2])
C1513375 (UMLS CUI [2,3])
C1275491 (UMLS CUI [3])
Heart failure | Cardiac ejection fraction | Diastolic dysfunction
Item
6. presence of hf with an ejection fraction less than 40%, or diastolic dysfunction
boolean
C0018801 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
C0520863 (UMLS CUI [3])
Informed Consent
Item
7. ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
8. at least18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recent myocardial infarction
Item
1. history of recent myocardial infarction (1 month)
boolean
C1998297 (UMLS CUI [1])
Angina Pectoris | Nitrates Disease Management Inadequate
Item
2. angina not adequately managed with nitrates.
boolean
C0002962 (UMLS CUI [1])
C0028125 (UMLS CUI [2,1])
C0376636 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Aortic Valve Stenosis | Mitral Valve Stenosis
Item
3. aortic or mitral stenosis
boolean
C0003507 (UMLS CUI [1])
C0026269 (UMLS CUI [2])
Coronary revascularisation | Mitral valvuloplasty | Cardiac Surgery | Biventricular pacemaker insertion
Item
4. coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
boolean
C0877341 (UMLS CUI [1])
C0396849 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
C3805138 (UMLS CUI [4])
Severe chronic obstructive pulmonary disease
Item
5. severe copd
boolean
C0730607 (UMLS CUI [1])
Cerebrovascular accident | Neurologic Deficits cerebral
Item
6. recent stroke or significant cerebral neurologic impairment.
boolean
C0038454 (UMLS CUI [1])
C0521654 (UMLS CUI [2,1])
C0006104 (UMLS CUI [2,2])
Suicidality
Item
7. active suicidality
boolean
C3166387 (UMLS CUI [1])
Participation Exercise Program
Item
8. currently participating in an exercise program.
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
Mood Stabilizer | Lithium | Benzodiazepines | Antipsychotic Agents
Item
9. currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
boolean
C2917435 (UMLS CUI [1])
C0023870 (UMLS CUI [2])
C0005064 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
Pharmaceutical Preparations Affecting Immunity | Steroids Affecting Immunity | Medical condition Affecting Immunity | Graves Disease | Rheumatoid Arthritis | Hashimoto Disease | Sjogren's Syndrome | Lupus Erythematosus | Multiple Sclerosis
Item
10. medications (steroids) and medical conditions affecting immune status not limited to grave's disease, rheumatoid arthritis, hashimoto's disease, sjogren's disease, lupus, multiple sclerosis
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0020964 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0020964 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0020964 (UMLS CUI [3,3])
C0018213 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0677607 (UMLS CUI [6])
C1527336 (UMLS CUI [7])
C0409974 (UMLS CUI [8])
C0026769 (UMLS CUI [9])
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