Eligibility Heart Failure NCT01829152

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult (≥ 18 years of age)
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
2. a least 1 prior hospitalization within the past 12 months for hf based upon the presence of at least 1 symptom (dyspnea, orthopnea, or edema) and at least 1 sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)and treatment with a loop diuretic during the hospital stay or symptoms of new york hospital association (nyha) class 2+ symptoms: dyspnea, fatigue, or chest pain with normal physical activity (class ii), less than ordinary activity (class iii) or at rest (class iv).
Description

Hospitalization Due to Heart Failure Quantity | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Signs Quantity | Rales | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest radiography | Loop Diuretics | Symptoms New York Heart Association Classification | Dyspnea | Fatigue | Chest Pain Physical activity Normal New York Heart Association Classification | Chest Pain Physical activity decreased New York Heart Association Classification | Chest pain at rest New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0085619
UMLS CUI [5]
C0013604
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C1265611
UMLS CUI [7]
C0034642
UMLS CUI [8]
C0085649
UMLS CUI [9]
C0003962
UMLS CUI [10,1]
C0242073
UMLS CUI [10,2]
C1801960
UMLS CUI [10,3]
C0039985
UMLS CUI [11]
C0354100
UMLS CUI [12,1]
C1457887
UMLS CUI [12,2]
C1275491
UMLS CUI [13]
C0013404
UMLS CUI [14]
C0015672
UMLS CUI [15,1]
C0008031
UMLS CUI [15,2]
C0026606
UMLS CUI [15,3]
C0205307
UMLS CUI [15,4]
C1275491
UMLS CUI [16,1]
C0008031
UMLS CUI [16,2]
C0391853
UMLS CUI [16,3]
C1275491
UMLS CUI [17,1]
C0392685
UMLS CUI [17,2]
C1275491
information may be provided by subject self-report obtained during the initial screening process and/or by medical record confirmation. compliance with all eligibility criteria will be confirmed at the initial study visit before subject is presented with the icf.
Description

Patient Self-Report | Medical Record | Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C0681906
UMLS CUI [2]
C0025102
UMLS CUI [3]
C1321605
3. receiving care at the smh hf clinic and assessed by the clinic at least twice. (those who were seen in person on their first visit and then followed-up by telephone thereafter will be considered eligible).
Description

Care Heart failure Clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C1947933
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0442592
4. able to provide contact information for someone who agrees to provide information about the subject if the subject is not available to do so.
Description

Contact Information

Data type

boolean

Alias
UMLS CUI [1]
C1880174
5. capability of understanding and willingness to comply with the protocol and study requirements, assessed according to the principal investigator's judgment.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
6. ability to understand and willingness to sign a written informed consent document, assessed according to the principal investigator's judgment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. decline to participate in the study
Description

Study Subject Participation Status Refusal to Participate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1136454
2. reside in an area with limited to no verizon wireless coverage as determined by vz using the vz zip code coverage analysis technology.
Description

Residence Wireless communication systems Limited | Residence Wireless communication systems Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C3825042
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0237096
UMLS CUI [2,2]
C3825042
UMLS CUI [2,3]
C0332197
3. scheduled procedure for left ventricular device implantation, or listed for potential cardiac transplant
Description

Implantation of left ventricular assist device Scheduled | Patient on waiting list Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0422768
UMLS CUI [2,2]
C0018823
4. current resident of a long-term care or skilled nursing facility
Description

Resident Long-term care facility | Resident Skilled nursing facility

Data type

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C3845067
UMLS CUI [2,1]
C2347958
UMLS CUI [2,2]
C0037265
5. currently receiving palliative or hospice care
Description

Palliative Care | Hospice Care

Data type

boolean

Alias
UMLS CUI [1]
C0030231
UMLS CUI [2]
C0085555
6. human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids) based on past medical history or subject self-report
Description

HIV Infection | AIDS

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
7. dialysis-dependent, end-stage renal disease
Description

Dependence on renal dialysis | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524376
UMLS CUI [2]
C0022661
8. a concurrent physical condition (including rare or chronic diseases such as sickle cell anemia or cystic fibrosis) or mental health condition (including dementia, schizophrenia, or other mental illness) that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol requirements or affect the subject's safety during the study
Description

Physical Condition compromises Protocol Compliance | Physical Condition Affecting Patient safety | Rare Diseases | Chronic disease | Anemia, Sickle Cell | Cystic Fibrosis | Mental condition compromises Protocol Compliance | Mental condition Affecting Patient safety | Dementia | Schizophrenia | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1113679
UMLS CUI [3]
C0678236
UMLS CUI [4]
C0008679
UMLS CUI [5]
C0002895
UMLS CUI [6]
C0010674
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0392760
UMLS CUI [8,3]
C1113679
UMLS CUI [9]
C0497327
UMLS CUI [10]
C0036341
UMLS CUI [11]
C0004936
9. are unable or unwilling to comply with the study requirements as instructed including coming to the smh hf clinic for the 2 study visits.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
10. for subjects in the intervention group that are:
Description

Intervention group

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1320290
1. unable or unwilling to return to the smh clinic to receive their training, devices and study material after signing the informed consent form and being randomized into the intervention group;
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
2. unable or unwilling to use the biometric devices and chm at least one time per day.
Description

Use of Biometry Device Unable | Use of Biometry Device Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0005544
UMLS CUI [1,3]
C0025080
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0005544
UMLS CUI [2,3]
C0025080
UMLS CUI [2,4]
C0558080
11. are pregnant or planning to become pregnant during the study.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992

Similar models

Eligibility Heart Failure NCT01829152

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
1. adult (≥ 18 years of age)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hospitalization Due to Heart Failure Quantity | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Signs Quantity | Rales | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest radiography | Loop Diuretics | Symptoms New York Heart Association Classification | Dyspnea | Fatigue | Chest Pain Physical activity Normal New York Heart Association Classification | Chest Pain Physical activity decreased New York Heart Association Classification | Chest pain at rest New York Heart Association Classification
Item
2. a least 1 prior hospitalization within the past 12 months for hf based upon the presence of at least 1 symptom (dyspnea, orthopnea, or edema) and at least 1 sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)and treatment with a loop diuretic during the hospital stay or symptoms of new york hospital association (nyha) class 2+ symptoms: dyspnea, fatigue, or chest pain with normal physical activity (class ii), less than ordinary activity (class iii) or at rest (class iv).
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013404 (UMLS CUI [3])
C0085619 (UMLS CUI [4])
C0013604 (UMLS CUI [5])
C0311392 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0034642 (UMLS CUI [7])
C0085649 (UMLS CUI [8])
C0003962 (UMLS CUI [9])
C0242073 (UMLS CUI [10,1])
C1801960 (UMLS CUI [10,2])
C0039985 (UMLS CUI [10,3])
C0354100 (UMLS CUI [11])
C1457887 (UMLS CUI [12,1])
C1275491 (UMLS CUI [12,2])
C0013404 (UMLS CUI [13])
C0015672 (UMLS CUI [14])
C0008031 (UMLS CUI [15,1])
C0026606 (UMLS CUI [15,2])
C0205307 (UMLS CUI [15,3])
C1275491 (UMLS CUI [15,4])
C0008031 (UMLS CUI [16,1])
C0391853 (UMLS CUI [16,2])
C1275491 (UMLS CUI [16,3])
C0392685 (UMLS CUI [17,1])
C1275491 (UMLS CUI [17,2])
Patient Self-Report | Medical Record | Compliance behavior
Item
information may be provided by subject self-report obtained during the initial screening process and/or by medical record confirmation. compliance with all eligibility criteria will be confirmed at the initial study visit before subject is presented with the icf.
boolean
C0681906 (UMLS CUI [1])
C0025102 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
Care Heart failure Clinic
Item
3. receiving care at the smh hf clinic and assessed by the clinic at least twice. (those who were seen in person on their first visit and then followed-up by telephone thereafter will be considered eligible).
boolean
C1947933 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0442592 (UMLS CUI [1,3])
Contact Information
Item
4. able to provide contact information for someone who agrees to provide information about the subject if the subject is not available to do so.
boolean
C1880174 (UMLS CUI [1])
Protocol Compliance
Item
5. capability of understanding and willingness to comply with the protocol and study requirements, assessed according to the principal investigator's judgment.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
6. ability to understand and willingness to sign a written informed consent document, assessed according to the principal investigator's judgment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Refusal to Participate
Item
1. decline to participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
Residence Wireless communication systems Limited | Residence Wireless communication systems Absent
Item
2. reside in an area with limited to no verizon wireless coverage as determined by vz using the vz zip code coverage analysis technology.
boolean
C0237096 (UMLS CUI [1,1])
C3825042 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0237096 (UMLS CUI [2,1])
C3825042 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Implantation of left ventricular assist device Scheduled | Patient on waiting list Heart Transplantation
Item
3. scheduled procedure for left ventricular device implantation, or listed for potential cardiac transplant
boolean
C0397130 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
Resident Long-term care facility | Resident Skilled nursing facility
Item
4. current resident of a long-term care or skilled nursing facility
boolean
C2347958 (UMLS CUI [1,1])
C3845067 (UMLS CUI [1,2])
C2347958 (UMLS CUI [2,1])
C0037265 (UMLS CUI [2,2])
Palliative Care | Hospice Care
Item
5. currently receiving palliative or hospice care
boolean
C0030231 (UMLS CUI [1])
C0085555 (UMLS CUI [2])
HIV Infection | AIDS
Item
6. human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids) based on past medical history or subject self-report
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Dependence on renal dialysis | Kidney Failure, Chronic
Item
7. dialysis-dependent, end-stage renal disease
boolean
C0524376 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
Physical Condition compromises Protocol Compliance | Physical Condition Affecting Patient safety | Rare Diseases | Chronic disease | Anemia, Sickle Cell | Cystic Fibrosis | Mental condition compromises Protocol Compliance | Mental condition Affecting Patient safety | Dementia | Schizophrenia | Mental disorders
Item
8. a concurrent physical condition (including rare or chronic diseases such as sickle cell anemia or cystic fibrosis) or mental health condition (including dementia, schizophrenia, or other mental illness) that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol requirements or affect the subject's safety during the study
boolean
C3714565 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0678236 (UMLS CUI [3])
C0008679 (UMLS CUI [4])
C0002895 (UMLS CUI [5])
C0010674 (UMLS CUI [6])
C3840291 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0392760 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
C0497327 (UMLS CUI [9])
C0036341 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
9. are unable or unwilling to comply with the study requirements as instructed including coming to the smh hf clinic for the 2 study visits.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Intervention group
Item
10. for subjects in the intervention group that are:
boolean
C0184661 (UMLS CUI [1,1])
C1320290 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
1. unable or unwilling to return to the smh clinic to receive their training, devices and study material after signing the informed consent form and being randomized into the intervention group;
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Use of Biometry Device Unable | Use of Biometry Device Unwilling
Item
2. unable or unwilling to use the biometric devices and chm at least one time per day.
boolean
C1524063 (UMLS CUI [1,1])
C0005544 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C1524063 (UMLS CUI [2,1])
C0005544 (UMLS CUI [2,2])
C0025080 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Pregnancy | Pregnancy, Planned
Item
11. are pregnant or planning to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])