ID

29577

Descripción

A Family Intervention for Improving Self-Care of Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00645489

Link

https://clinicaltrials.gov/show/NCT00645489

Palabras clave

Versiones (1)
  1. 6/4/18 6/4/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de abril de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00645489

Inglés

Eligibility Heart Failure, Congestive NCT00645489

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. stage c heart failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. indicated by chronic systolic dysfunction (left ventricle [lv] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the lv), or both.
Descripción

Heart failure Stage | Symptoms Heart failure | Structural disorder of heart | Systolic dysfunction chronic | Left ventricular ejection fraction | Diastolic dysfunction | Left ventricle Compliance Decreased Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1306673
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0018801
UMLS CUI [3]
C1290384
UMLS CUI [4,1]
C0749225
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0428772
UMLS CUI [6]
C0520863
UMLS CUI [7,1]
C0225897
UMLS CUI [7,2]
C0009563
UMLS CUI [7,3]
C0205216
UMLS CUI [7,4]
C0013516
2. the patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
Descripción

Prophylactic treatment Decompensation | Diuretic therapy | Fluid restriction | Dietary sodium intake Restriction | Dietary sodium intake Reduction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C0231187
UMLS CUI [2]
C0948575
UMLS CUI [3]
C0204700
UMLS CUI [4,1]
C0425433
UMLS CUI [4,2]
C0443288
UMLS CUI [5,1]
C0425433
UMLS CUI [5,2]
C0392756
3. a family member or members available for study participation with whom patient lives for at least 5 days a week. emphasis will be given to the closest family members available (i.e., spouse).
Descripción

Participation Clinical Trial Family member Available

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0086282
UMLS CUI [1,4]
C0470187
4. subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
5. patients will be age 50 or above. younger patients may have a different family environment than the most common type of patient who is the target of the fpi intervention.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has a well-documented diagnosis of dementia
Descripción

Dementia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497327
2. moderate or greater cognitive impairment, based on the blessed test of orientation, memory, and concentration (bomc)[26] score of 16.
Descripción

Moderate cognitive impairment BOMC score | Severe cognitive impairment BOMC score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3839816
UMLS CUI [1,2]
C3838395
UMLS CUI [2,1]
C3554639
UMLS CUI [2,2]
C3838395
3. patient's family member has bomc score of 10 (i.e., mild or greater cognitive impairment).
Descripción

Family member BOMC score | Mild cognitive disorder | Moderate cognitive impairment | Severe cognitive impairment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086282
UMLS CUI [1,2]
C3838395
UMLS CUI [2]
C1270972
UMLS CUI [3]
C3839816
UMLS CUI [4]
C3554639
4. inability to communicate verbally, major visual impairment, uncorrected hearing loss.
Descripción

Lacking Able to use verbal communication | Visual Impairment Major | Hearing Loss uncorrected

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712064
UMLS CUI [2,1]
C3665347
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C3887873
UMLS CUI [3,2]
C4072785
5. patient and/or family member reports "frequent use" illicit substance abuse within the past year. scores on the audit-c 4 indicating alcohol abuse/dependence.[30]
Descripción

Illicit Substance abuse | Illicit Substance abuse Family member | Alcohol abuse AUDIT-C | Alcohol dependence AUDIT-C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2697662
UMLS CUI [1,2]
C0013146
UMLS CUI [2,1]
C2697662
UMLS CUI [2,2]
C0013146
UMLS CUI [2,3]
C0086282
UMLS CUI [3,1]
C0085762
UMLS CUI [3,2]
C3871151
UMLS CUI [4,1]
C0001973
UMLS CUI [4,2]
C3871151
6. patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder).
Descripción

Schizophrenia | Schizoaffective Disorder | Schizophrenia Family member | Schizoaffective Disorder Family member

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C0086282
UMLS CUI [4,1]
C0036337
UMLS CUI [4,2]
C0086282
7. patient indicates active suicidal ideation and evaluated as a clinical risk.
Descripción

Feeling suicidal | Patient At risk Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0205210
8. patient is in the philadelphia vamc home-telehealth program or some other incompatible intervention.
Descripción

Participation Telehealth Program | Intervention Inconsistent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C1328956
UMLS CUI [1,3]
C3484370
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0442809
9. patient has an unstable medical condition that would likely prevent the subject from completing the study.
Descripción

Medical condition Unstable Preventing Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C2732579
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Similar models

Eligibility Heart Failure, Congestive NCT00645489

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Stage | Symptoms Heart failure | Structural disorder of heart | Systolic dysfunction chronic | Left ventricular ejection fraction | Diastolic dysfunction | Left ventricle Compliance Decreased Echocardiography
Item
1. stage c heart failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. indicated by chronic systolic dysfunction (left ventricle [lv] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the lv), or both.
boolean
C0018801 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C1290384 (UMLS CUI [3])
C0749225 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5])
C0520863 (UMLS CUI [6])
C0225897 (UMLS CUI [7,1])
C0009563 (UMLS CUI [7,2])
C0205216 (UMLS CUI [7,3])
C0013516 (UMLS CUI [7,4])
Prophylactic treatment Decompensation | Diuretic therapy | Fluid restriction | Dietary sodium intake Restriction | Dietary sodium intake Reduction
Item
2. the patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake.
boolean
C0199176 (UMLS CUI [1,1])
C0231187 (UMLS CUI [1,2])
C0948575 (UMLS CUI [2])
C0204700 (UMLS CUI [3])
C0425433 (UMLS CUI [4,1])
C0443288 (UMLS CUI [4,2])
C0425433 (UMLS CUI [5,1])
C0392756 (UMLS CUI [5,2])
Participation Clinical Trial Family member Available
Item
3. a family member or members available for study participation with whom patient lives for at least 5 days a week. emphasis will be given to the closest family members available (i.e., spouse).
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
Informed Consent
Item
4. subjects are able to give informed consent (see below for exclusion due to well-documented dementia or evidence of cognitive impairment).
boolean
C0021430 (UMLS CUI [1])
Age
Item
5. patients will be age 50 or above. younger patients may have a different family environment than the most common type of patient who is the target of the fpi intervention.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Dementia
Item
1. patient has a well-documented diagnosis of dementia
boolean
C0497327 (UMLS CUI [1])
Moderate cognitive impairment BOMC score | Severe cognitive impairment BOMC score
Item
2. moderate or greater cognitive impairment, based on the blessed test of orientation, memory, and concentration (bomc)[26] score of 16.
boolean
C3839816 (UMLS CUI [1,1])
C3838395 (UMLS CUI [1,2])
C3554639 (UMLS CUI [2,1])
C3838395 (UMLS CUI [2,2])
Family member BOMC score | Mild cognitive disorder | Moderate cognitive impairment | Severe cognitive impairment
Item
3. patient's family member has bomc score of 10 (i.e., mild or greater cognitive impairment).
boolean
C0086282 (UMLS CUI [1,1])
C3838395 (UMLS CUI [1,2])
C1270972 (UMLS CUI [2])
C3839816 (UMLS CUI [3])
C3554639 (UMLS CUI [4])
Lacking Able to use verbal communication | Visual Impairment Major | Hearing Loss uncorrected
Item
4. inability to communicate verbally, major visual impairment, uncorrected hearing loss.
boolean
C0332268 (UMLS CUI [1,1])
C2712064 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C3887873 (UMLS CUI [3,1])
C4072785 (UMLS CUI [3,2])
Illicit Substance abuse | Illicit Substance abuse Family member | Alcohol abuse AUDIT-C | Alcohol dependence AUDIT-C
Item
5. patient and/or family member reports "frequent use" illicit substance abuse within the past year. scores on the audit-c 4 indicating alcohol abuse/dependence.[30]
boolean
C2697662 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C2697662 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
C0086282 (UMLS CUI [2,3])
C0085762 (UMLS CUI [3,1])
C3871151 (UMLS CUI [3,2])
C0001973 (UMLS CUI [4,1])
C3871151 (UMLS CUI [4,2])
Schizophrenia | Schizoaffective Disorder | Schizophrenia Family member | Schizoaffective Disorder Family member
Item
6. patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder).
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0036341 (UMLS CUI [3,1])
C0086282 (UMLS CUI [3,2])
C0036337 (UMLS CUI [4,1])
C0086282 (UMLS CUI [4,2])
Feeling suicidal | Patient At risk Clinical
Item
7. patient indicates active suicidal ideation and evaluated as a clinical risk.
boolean
C0424000 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Participation Telehealth Program | Intervention Inconsistent
Item
8. patient is in the philadelphia vamc home-telehealth program or some other incompatible intervention.
boolean
C0679823 (UMLS CUI [1,1])
C1328956 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
Medical condition Unstable Preventing Completion of clinical trial
Item
9. patient has an unstable medical condition that would likely prevent the subject from completing the study.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
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