ID

35964

Beskrivning

Blended Collaborative Care for Heart Failure and Co-Morbid Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02044211

Länk

https://clinicaltrials.gov/show/NCT02044211

Nyckelord

Versioner (1)
  1. 2019-04-06 2019-04-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure, Systolic NCT02044211

Engelsk

Eligibility Heart Failure, Systolic NCT02044211

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. systolic heart failure (documented ejection fraction ≤ 40%).
Beskrivning

Heart Failure, Systolic | Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C0232174
2. hf symptoms meeting criteria for new york heart association (nyha) classes ii, iii or iv.
Beskrivning

Heart failure Symptoms New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
3. inpatient two-item patient health questionnaire (phq-2) screen-positive for depression; or phq-2 screen negative for depression and phq-9 <5 if non-depressed control.
Beskrivning

Patient Health Questionnaire-2 Positive Depressive disorder | Patient Health Questionnaire-2 Negative Depressive disorder | PHQ-9

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2706101
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0011581
UMLS CUI [2,1]
C2706101
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0011581
UMLS CUI [3]
C4083201
4. phq-9 ≥ 10 when reassessed two-weeks following hospital discharge, or phq-9 <5 if non-depressed control.
Beskrivning

PHQ-9 Post Discharge from hospital | PHQ-9

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4083201
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0586003
UMLS CUI [2]
C4083201
5. no cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the montreal cognitive assessment).
Beskrivning

Impaired cognition Absent | Impaired cognition Treating | donepezil | Montreal cognitive assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C1522326
UMLS CUI [3]
C0527316
UMLS CUI [4]
C3496286
6. able to be evaluated and treated for depression as an outpatient.
Beskrivning

Evaluation Depressive disorder Outpatient | Therapy Depressive disorder Outpatient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0011581
UMLS CUI [1,3]
C0029921
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011581
UMLS CUI [2,3]
C0029921
7. english speaking, not illiterate, or possessing any other communication barrier.
Beskrivning

Able to speak English Language | Illiteracy Absent | Communication Barrier Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0020899
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0009454
UMLS CUI [3,2]
C0332197
8. have a household telephone.
Beskrivning

Availability of Telephone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0039457
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. receiving active treatment for a mood or anxiety disorder from a mental health specialist.
Beskrivning

Therapy Mood Disorder | Therapy Anxiety Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0525045
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0003469
2. unstable medical condition as indicated by history, physical, and/or laboratory findings.
Beskrivning

Patient's condition unstable Medical History | Patient's condition unstable Physical findings | Patient's condition unstable Laboratory finding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0438114
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0438114
UMLS CUI [2,2]
C0311392
UMLS CUI [3,1]
C0438114
UMLS CUI [3,2]
C0587081
3. presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
Beskrivning

Condition Probably Fatal | Exception Condition Cardiovascular | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0750492
UMLS CUI [1,3]
C1302234
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C3887460
UMLS CUI [3]
C0006826
4. organic mood syndromes, including those secondary to medical illness or drugs.
Beskrivning

Organic mood disorder | Organic mood disorder Secondary to Illness | Organic mood disorder Secondary to Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0029232
UMLS CUI [2,1]
C0029232
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0221423
UMLS CUI [3,1]
C0029232
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0013227
5. active suicidal ideation.
Beskrivning

Feeling suicidal

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
6. current or history of psychotic illness.
Beskrivning

Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0033975
7. current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
Beskrivning

Bipolar Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
8. current alcohol or other substance abuse as evidenced by chart review and the audit-c questionnaire.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
9. age ≤ 21 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Heart Failure, Systolic NCT02044211

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart Failure, Systolic | Cardiac ejection fraction
Item
1. systolic heart failure (documented ejection fraction ≤ 40%).
boolean
C1135191 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
Heart failure Symptoms New York Heart Association Classification
Item
2. hf symptoms meeting criteria for new york heart association (nyha) classes ii, iii or iv.
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Patient Health Questionnaire-2 Positive Depressive disorder | Patient Health Questionnaire-2 Negative Depressive disorder | PHQ-9
Item
3. inpatient two-item patient health questionnaire (phq-2) screen-positive for depression; or phq-2 screen negative for depression and phq-9 <5 if non-depressed control.
boolean
C2706101 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C2706101 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0011581 (UMLS CUI [2,3])
C4083201 (UMLS CUI [3])
PHQ-9 Post Discharge from hospital | PHQ-9
Item
4. phq-9 ≥ 10 when reassessed two-weeks following hospital discharge, or phq-9 <5 if non-depressed control.
boolean
C4083201 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0586003 (UMLS CUI [1,3])
C4083201 (UMLS CUI [2])
Impaired cognition Absent | Impaired cognition Treating | donepezil | Montreal cognitive assessment
Item
5. no cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the montreal cognitive assessment).
boolean
C0338656 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0527316 (UMLS CUI [3])
C3496286 (UMLS CUI [4])
Evaluation Depressive disorder Outpatient | Therapy Depressive disorder Outpatient
Item
6. able to be evaluated and treated for depression as an outpatient.
boolean
C1261322 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
C0029921 (UMLS CUI [2,3])
Able to speak English Language | Illiteracy Absent | Communication Barrier Absent
Item
7. english speaking, not illiterate, or possessing any other communication barrier.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0020899 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009454 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Availability of Telephone
Item
8. have a household telephone.
boolean
C0470187 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapy Mood Disorder | Therapy Anxiety Disorder
Item
1. receiving active treatment for a mood or anxiety disorder from a mental health specialist.
boolean
C0087111 (UMLS CUI [1,1])
C0525045 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0003469 (UMLS CUI [2,2])
Patient's condition unstable Medical History | Patient's condition unstable Physical findings | Patient's condition unstable Laboratory finding
Item
2. unstable medical condition as indicated by history, physical, and/or laboratory findings.
boolean
C0438114 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0438114 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0438114 (UMLS CUI [3,1])
C0587081 (UMLS CUI [3,2])
Condition Probably Fatal | Exception Condition Cardiovascular | Malignant Neoplasms
Item
3. presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
boolean
C0348080 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C3887460 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3])
Organic mood disorder | Organic mood disorder Secondary to Illness | Organic mood disorder Secondary to Pharmaceutical Preparations
Item
4. organic mood syndromes, including those secondary to medical illness or drugs.
boolean
C0029232 (UMLS CUI [1])
C0029232 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0221423 (UMLS CUI [2,3])
C0029232 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
Feeling suicidal
Item
5. active suicidal ideation.
boolean
C0424000 (UMLS CUI [1])
Psychotic Disorders
Item
6. current or history of psychotic illness.
boolean
C0033975 (UMLS CUI [1])
Bipolar Disorder
Item
7. current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
boolean
C0005586 (UMLS CUI [1])
Substance Use Disorders
Item
8. current alcohol or other substance abuse as evidenced by chart review and the audit-c questionnaire.
boolean
C0038586 (UMLS CUI [1])
Age
Item
9. age ≤ 21 years.
boolean
C0001779 (UMLS CUI [1])
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