ID

39536

Beskrivning

The Congestive Heart Failure Adherence Redesign Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01698242

Länk

https://clinicaltrials.gov/show/NCT01698242

Nyckelord

Versioner (1)
  1. 2020-01-25 2020-01-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 januari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT01698242

Engelsk

Eligibility Heart Failure, Congestive NCT01698242

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria (pcp) 1. provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s).
Beskrivning

Inclusion criteria Primary care provider | Management Pharmaceutical Preparations Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2735026
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0018801
inclusion criteria (patients)
Beskrivning

Inclusion criteria Patients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030705
1. participant has been diagnosed with heart failure (hf),
Beskrivning

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
2. self reported family income is less than $30,000/year,
Beskrivning

Family Income

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C0021162
3. has experienced at least one hospitalization for acute, decompensated, hf within the previous 6 months based upon:
Beskrivning

Hospitalization Quantity Decompensated cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0581377
1. being admitted for symptoms of hf (ex: peripheral edema, shortness of breath and fatigue), and
Beskrivning

Admission Symptoms Heart failure | Peripheral edema | Dyspnea | Fatigue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0085649
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0015672
2. responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ace inhibitors, arbs, or beta blockers.
Beskrivning

Disease Response Therapy Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0018801
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5]
C0304516
4. has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year.
Beskrivning

Systolic dysfunction | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Cardiac ventriculography | Cardiac ejection fraction Radionuclide Ventriculography

Datatyp

boolean

Alias
UMLS CUI [1]
C0749225
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0596683
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C0034610
5. age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. currently resides in cook county, illinois.
Beskrivning

Residence

Datatyp

boolean

Alias
UMLS CUI [1]
C0237096
7. 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
8. the primary care provider (pcp) has consented and has no more than 12 patients enrolled.
Beskrivning

Consent Primary care provider

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C2735026
9. completed the informed consent process.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
10. successfully completed the 30-day run-in period and study baseline visit
Beskrivning

Run-in Period Completed | Baseline Visit Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C0008952
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria (pcp)
Beskrivning

Exclusion Criteria Primary care provider

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2735026
health providers will be excluded from enrollment if they are:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. still in their residency or training period,
Beskrivning

Residency | Training Period

Datatyp

boolean

Alias
UMLS CUI [1]
C0035182
UMLS CUI [2,1]
C0220931
UMLS CUI [2,2]
C1948053
2. a member of the chart research staff.
Beskrivning

Member Research Personnel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0035173
exclusion criteria (patients)
Beskrivning

Exclusion Criteria Patients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030705
patients will be excluded from enrollment if they have:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. an uncertain 12-month prognosis.
Beskrivning

Prognosis uncertain

Datatyp

boolean

Alias
UMLS CUI [1]
C0420835
1. listed for imminent cardiac transplant.
Beskrivning

Patient on waiting list Heart Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
2. has an advanced directive of "do not resuscitate".
Beskrivning

Do-Not-Resuscitate Orders

Datatyp

boolean

Alias
UMLS CUI [1]
C0079252
3. has uncertain 12-month prognosis, as adjudicated by the principal investigator
Beskrivning

Prognosis uncertain Principal Investigator

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0420835
UMLS CUI [1,2]
C1521895
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Similar models

Eligibility Heart Failure, Congestive NCT01698242

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Primary care provider | Management Pharmaceutical Preparations Heart failure
Item
inclusion criteria (pcp) 1. provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s).
boolean
C1512693 (UMLS CUI [1,1])
C2735026 (UMLS CUI [1,2])
C0376636 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
Inclusion criteria Patients
Item
inclusion criteria (patients)
boolean
C1512693 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Heart failure
Item
1. participant has been diagnosed with heart failure (hf),
boolean
C0018801 (UMLS CUI [1])
Family Income
Item
2. self reported family income is less than $30,000/year,
boolean
C0015576 (UMLS CUI [1,1])
C0021162 (UMLS CUI [1,2])
Hospitalization Quantity Decompensated cardiac failure
Item
3. has experienced at least one hospitalization for acute, decompensated, hf within the previous 6 months based upon:
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,3])
Admission Symptoms Heart failure | Peripheral edema | Dyspnea | Fatigue
Item
1. being admitted for symptoms of hf (ex: peripheral edema, shortness of breath and fatigue), and
boolean
C0030673 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0085649 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0015672 (UMLS CUI [4])
Disease Response Therapy Heart failure | Diuretics | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists
Item
2. responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ace inhibitors, arbs, or beta blockers.
boolean
C1704632 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0012798 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
Systolic dysfunction | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Cardiac ventriculography | Cardiac ejection fraction Radionuclide Ventriculography
Item
4. has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year.
boolean
C0749225 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0596683 (UMLS CUI [3,2])
C0232174 (UMLS CUI [4,1])
C0034610 (UMLS CUI [4,2])
Age
Item
5. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Residence
Item
6. currently resides in cook county, illinois.
boolean
C0237096 (UMLS CUI [1])
Able to speak English Language | Able to speak Spanish Language
Item
7. 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])
Consent Primary care provider
Item
8. the primary care provider (pcp) has consented and has no more than 12 patients enrolled.
boolean
C1511481 (UMLS CUI [1,1])
C2735026 (UMLS CUI [1,2])
Informed Consent
Item
9. completed the informed consent process.
boolean
C0021430 (UMLS CUI [1])
Run-in Period Completed | Baseline Visit Completed
Item
10. successfully completed the 30-day run-in period and study baseline visit
boolean
C3274438 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1442488 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Primary care provider
Item
exclusion criteria (pcp)
boolean
C0680251 (UMLS CUI [1,1])
C2735026 (UMLS CUI [1,2])
Criteria Fulfill
Item
health providers will be excluded from enrollment if they are:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Residency | Training Period
Item
1. still in their residency or training period,
boolean
C0035182 (UMLS CUI [1])
C0220931 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
Member Research Personnel
Item
2. a member of the chart research staff.
boolean
C0680022 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
Exclusion Criteria Patients
Item
exclusion criteria (patients)
boolean
C0680251 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Criteria Fulfill
Item
patients will be excluded from enrollment if they have:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prognosis uncertain
Item
1. an uncertain 12-month prognosis.
boolean
C0420835 (UMLS CUI [1])
Patient on waiting list Heart Transplantation
Item
1. listed for imminent cardiac transplant.
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
Do-Not-Resuscitate Orders
Item
2. has an advanced directive of "do not resuscitate".
boolean
C0079252 (UMLS CUI [1])
Prognosis uncertain Principal Investigator
Item
3. has uncertain 12-month prognosis, as adjudicated by the principal investigator
boolean
C0420835 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
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