ID

39522

Descripción

Lifestyle Change Program in Elderly Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02303275

Link

https://clinicaltrials.gov/show/NCT02303275

Palabras clave

Versiones (1)
  1. 23/1/20 23/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

23 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02303275

Inglés

Eligibility Heart Failure NCT02303275

1 formularios  
Criteria
Descripción

Criteria

1. male or female, over 18
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. able to commit to participating in the lifestyle change program:
Descripción

Participation Lifestyle change therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C2960841
4 -5 hours per day
Descripción

Hours per day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0556974
3 days per week
Descripción

Days per week

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677547
for a total of 12-weeks
Descripción

Weeks Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C1265611
3. history of chf with systolic dysfunction (ef <45%) or history of heart failure with preserved ejection fraction (hfpef)
Descripción

Chronic heart failure | Systolic dysfunction | Cardiac ejection fraction | Heart failure with preserved ejection fraction [HFpEF]

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2]
C0749225
UMLS CUI [3]
C0232174
UMLS CUI [4]
C4509226
4. must have had one previous admission for acute decompensated heart failure within the past year at time of enrollment.
Descripción

Admission Quantity Decompensated cardiac failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0581377
5. new york heart association (nyha) class ii - iii symptoms:
Descripción

Symptoms New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
class ii: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Descripción

Symptom mild New York Heart Association Classification | Mildly Short of Breath | Angina Pectoris Mild | Limitation Slight During Activity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0436343
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C4054523
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C2945599
UMLS CUI [4,1]
C0449295
UMLS CUI [4,2]
C2937276
UMLS CUI [4,3]
C0347984
UMLS CUI [4,4]
C0026606
class iii: marked limitation in activity due to symptoms, even during less-than-
Descripción

Symptoms New York Heart Association Classification | Limitation Marked Activity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0449295
UMLS CUI [2,2]
C1706089
UMLS CUI [2,3]
C0026606
ordinary activity, e.g. walking short distances (20-100 m). comfortable only at rest.
Descripción

Walking - short distance - difficulty

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3258329
6. labs: complete blood count, comprehensive metabolic panel must have been stable within the last 3 month.
Descripción

Laboratory Results | Complete Blood Count | Comprehensive Metabolic Panel Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0009555
UMLS CUI [3,1]
C0519825
UMLS CUI [3,2]
C0205360
7. exercise: must be able to do some gentle exercises
Descripción

Ability Exercise Slight

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C2937276
exclusions
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
1. severe medical condition(s) that preclude participation in the lifestyle change program
Descripción

Medical condition Excludes Lifestyle change therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C2960841
2. unable to travel to the scripps center for integrated medicine gym 3 times a week for 12 weeks
Descripción

Travel Unable Fitness Center

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0600623
3. severe cognitive, language, and psychosocial disabilities that prevent participation in the lifestyle change program
Descripción

Impaired cognition Preventing Lifestyle change therapy | Language Disability Preventing Lifestyle change therapy | Psychosocial problem Preventing Lifestyle change therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2960841
UMLS CUI [2,1]
C0023015
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2960841
UMLS CUI [3,1]
C0740697
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C2960841
4. unsafe to participate in the exercise program based on the american college of sports medicine safety criteria such as:
Descripción

Participation Exercise Program At risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C3484370
UMLS CUI [1,4]
C1444641
refractory chest pain
Descripción

Chest Pain refractory

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0205269
poorly controlled arrhythmias causing hemodynamic symptoms
Descripción

Cardiac Arrhythmia Poorly controlled | Cardiac Arrhythmia Causing Symptoms Hemodynamic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1457887
UMLS CUI [2,4]
C0019010
high degree atrioventricular block
Descripción

Second degree atrioventricular block | Complete atrioventricular block

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
pacemakers which do not permit adequate heart rate response to exercise
Descripción

Artificial cardiac pacemaker | Heart rate response Inadequate Exercise

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2,1]
C1997754
UMLS CUI [2,2]
C0205412
UMLS CUI [2,3]
C0015259
significant uncorrected primary vascular disease
Descripción

Vascular Disease Primary uncorrected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042373
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C4072785
isolated pulmonary hypertension
Descripción

Pulmonary Hypertension Isolated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205409
poorly controlled symptomatic postural hypotension
Descripción

Orthostatic Hypotension Symptomatic Poorly controlled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C3853134
obstructive cardiomyopathies
Descripción

Cardiomyopathies Obstructive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0878544
UMLS CUI [1,2]
C0549186
5. severe untreated anemia.
Descripción

Severe Anemia Untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0238644
UMLS CUI [1,2]
C0332155
6. participation in another research study in the last month
Descripción

Study Subject Participation Status | Research study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
7. smoking
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Heart Failure NCT02303275

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age
Item
1. male or female, over 18
boolean
C0001779 (UMLS CUI [1])
Participation Lifestyle change therapy
Item
2. able to commit to participating in the lifestyle change program:
boolean
C0679823 (UMLS CUI [1,1])
C2960841 (UMLS CUI [1,2])
Hours per day
Item
4 -5 hours per day
boolean
C0556974 (UMLS CUI [1])
Days per week
Item
3 days per week
boolean
C0677547 (UMLS CUI [1])
Weeks Quantity
Item
for a total of 12-weeks
boolean
C0439230 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Chronic heart failure | Systolic dysfunction | Cardiac ejection fraction | Heart failure with preserved ejection fraction [HFpEF]
Item
3. history of chf with systolic dysfunction (ef <45%) or history of heart failure with preserved ejection fraction (hfpef)
boolean
C0264716 (UMLS CUI [1])
C0749225 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
C4509226 (UMLS CUI [4])
Admission Quantity Decompensated cardiac failure
Item
4. must have had one previous admission for acute decompensated heart failure within the past year at time of enrollment.
boolean
C0184666 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,3])
Symptoms New York Heart Association Classification
Item
5. new york heart association (nyha) class ii - iii symptoms:
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Symptom mild New York Heart Association Classification | Mildly Short of Breath | Angina Pectoris Mild | Limitation Slight During Activity
Item
class ii: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
boolean
C0436343 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C4054523 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0449295 (UMLS CUI [4,1])
C2937276 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C0026606 (UMLS CUI [4,4])
Symptoms New York Heart Association Classification | Limitation Marked Activity
Item
class iii: marked limitation in activity due to symptoms, even during less-than-
boolean
C1457887 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0449295 (UMLS CUI [2,1])
C1706089 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
Walking - short distance - difficulty
Item
ordinary activity, e.g. walking short distances (20-100 m). comfortable only at rest.
boolean
C3258329 (UMLS CUI [1])
Laboratory Results | Complete Blood Count | Comprehensive Metabolic Panel Stable
Item
6. labs: complete blood count, comprehensive metabolic panel must have been stable within the last 3 month.
boolean
C1254595 (UMLS CUI [1])
C0009555 (UMLS CUI [2])
C0519825 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Ability Exercise Slight
Item
7. exercise: must be able to do some gentle exercises
boolean
C0085732 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C2937276 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusions
boolean
C0680251 (UMLS CUI [1])
Medical condition Excludes Lifestyle change therapy
Item
1. severe medical condition(s) that preclude participation in the lifestyle change program
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C2960841 (UMLS CUI [1,3])
Travel Unable Fitness Center
Item
2. unable to travel to the scripps center for integrated medicine gym 3 times a week for 12 weeks
boolean
C0040802 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0600623 (UMLS CUI [1,3])
Impaired cognition Preventing Lifestyle change therapy | Language Disability Preventing Lifestyle change therapy | Psychosocial problem Preventing Lifestyle change therapy
Item
3. severe cognitive, language, and psychosocial disabilities that prevent participation in the lifestyle change program
boolean
C0338656 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2960841 (UMLS CUI [1,3])
C0023015 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2960841 (UMLS CUI [2,3])
C0740697 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C2960841 (UMLS CUI [3,3])
Participation Exercise Program At risk
Item
4. unsafe to participate in the exercise program based on the american college of sports medicine safety criteria such as:
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
Chest Pain refractory
Item
refractory chest pain
boolean
C0008031 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Cardiac Arrhythmia Poorly controlled | Cardiac Arrhythmia Causing Symptoms Hemodynamic
Item
poorly controlled arrhythmias causing hemodynamic symptoms
boolean
C0003811 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0019010 (UMLS CUI [2,4])
Second degree atrioventricular block | Complete atrioventricular block
Item
high degree atrioventricular block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Artificial cardiac pacemaker | Heart rate response Inadequate Exercise
Item
pacemakers which do not permit adequate heart rate response to exercise
boolean
C0030163 (UMLS CUI [1])
C1997754 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
Vascular Disease Primary uncorrected
Item
significant uncorrected primary vascular disease
boolean
C0042373 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,3])
Pulmonary Hypertension Isolated
Item
isolated pulmonary hypertension
boolean
C0020542 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
Orthostatic Hypotension Symptomatic Poorly controlled
Item
poorly controlled symptomatic postural hypotension
boolean
C0020651 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
Cardiomyopathies Obstructive
Item
obstructive cardiomyopathies
boolean
C0878544 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
Severe Anemia Untreated
Item
5. severe untreated anemia.
boolean
C0238644 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Study Subject Participation Status | Research study
Item
6. participation in another research study in the last month
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
Tobacco use
Item
7. smoking
boolean
C0543414 (UMLS CUI [1])
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