ID

39409

Descrição

Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System; ODM derived from: https://clinicaltrials.gov/show/NCT01275846

Link

https://clinicaltrials.gov/show/NCT01275846

Palavras-chave

Versões (1)
  1. 08/01/2020 08/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01275846

Inglês

Eligibility Heart Failure NCT01275846

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has a diagnosis of heart failure nyha and is currently in functional class ii- iv status.
Descrição

Heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patient has been hospitalized for an episode of acute hf decompensation within the last 30 days.
Descrição

Hospitalization Episode of Decompensated cardiac failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0581377
patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, copd, hypertension, may be included in this evaluation. these conditions shall be documented during enrollment.
Descrição

Comorbidity | Atrial Fibrillation | Diabetes Mellitus | Coronary Artery Disease | Chronic Obstructive Airway Disease | Hypertensive disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0011849
UMLS CUI [4]
C1956346
UMLS CUI [5]
C0024117
UMLS CUI [6]
C0020538
have telephone line or broadband internet availability to connect intel® health guide.
Descrição

Availability of Telephone | Availability of Internet

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0039457
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0282111
are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the intel® health guide.
Descrição

Patient Monitoring Completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030695
UMLS CUI [1,2]
C0205197
will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
live within a reasonable distance (30 miles or less) from the institution.
Descrição

Residence Nearby

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a life expectancy of less than six months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
live in a nursing home or other multi-member assisted living facility.
Descrição

Lives in a nursing home | Assisted living facility patient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0425205
UMLS CUI [2]
C4510636
intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
Descrição

Absence Home Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0449238
are unable to read english at a minimum 5th grade level.
Descrição

Lacking Able to read English Language Grade Level

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376245
UMLS CUI [1,4]
C0870612
do not live within a reasonable distance (30 miles or less) from the institution.
Descrição

Residence Remote

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205157
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Similar models

Eligibility Heart Failure NCT01275846

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
patient has a diagnosis of heart failure nyha and is currently in functional class ii- iv status.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Hospitalization Episode of Decompensated cardiac failure
Item
patient has been hospitalized for an episode of acute hf decompensation within the last 30 days.
boolean
C0019993 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0581377 (UMLS CUI [1,3])
Comorbidity | Atrial Fibrillation | Diabetes Mellitus | Coronary Artery Disease | Chronic Obstructive Airway Disease | Hypertensive disease
Item
patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, copd, hypertension, may be included in this evaluation. these conditions shall be documented during enrollment.
boolean
C0009488 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1956346 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
C0020538 (UMLS CUI [6])
Availability of Telephone | Availability of Internet
Item
have telephone line or broadband internet availability to connect intel® health guide.
boolean
C0470187 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C0282111 (UMLS CUI [2,2])
Patient Monitoring Completion
Item
are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the intel® health guide.
boolean
C0030695 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Informed Consent
Item
will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
boolean
C0021430 (UMLS CUI [1])
Residence Nearby
Item
live within a reasonable distance (30 miles or less) from the institution.
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
have a life expectancy of less than six months.
boolean
C0023671 (UMLS CUI [1])
Lives in a nursing home | Assisted living facility patient
Item
live in a nursing home or other multi-member assisted living facility.
boolean
C0425205 (UMLS CUI [1])
C4510636 (UMLS CUI [2])
Absence Home Duration
Item
intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
boolean
C0332197 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Lacking Able to read English Language Grade Level
Item
are unable to read english at a minimum 5th grade level.
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0870612 (UMLS CUI [1,4])
Residence Remote
Item
do not live within a reasonable distance (30 miles or less) from the institution.
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
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