ID

39509

Description

Evaluation of the AUTONOM@DOM Telemonitoring System for People With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02135458

Link

https://clinicaltrials.gov/show/NCT02135458

Keywords

Versions (1)
  1. 1/20/20 1/20/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 20, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02135458

English

Eligibility Heart Failure NCT02135458

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 60 years or more
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
covered by french social security system or equivalent
Description

Coverage Social security system

Data type

boolean

Alias
UMLS CUI [1,1]
C1551362
UMLS CUI [1,2]
C2371809
written informed consent signed by patient
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
heart failure diagnosed by a cardiologue
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
nyha stage ii, iii or iv
Description

Stage New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1306673
UMLS CUI [1,2]
C1275491
able to be followed-up for 1 year
Description

Patient Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
attend general healthcare education sessions
Description

Participation Education about health care

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C2095494
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
freedom restricted by judicial order
Description

Freedom Restricted Judicial aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0016694
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C0243116
under legal protection
Description

Protection of patient Legal

Data type

boolean

Alias
UMLS CUI [1,1]
C0412786
UMLS CUI [1,2]
C1301860
require peritoneal dialysis or hemofiltration
Description

Peritoneal Dialysis Required | Hemofiltration Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0031139
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0019014
UMLS CUI [2,2]
C1514873
participation refused by patient, primary care physician or cardiologist
Description

Refusal to Participate Patient | Refusal to Participate Primary Care Physicians | Refusal to Participate Cardiologist

Data type

boolean

Alias
UMLS CUI [1,1]
C1136454
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C1136454
UMLS CUI [2,2]
C0033131
UMLS CUI [3,1]
C1136454
UMLS CUI [3,2]
C0175906
present a severe comorbidity with poor short-term prognosis
Description

Comorbidity Severe | Poor prognosis short-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0278252
UMLS CUI [2,2]
C0443303
present asymptomatic heart failure nyha stage i
Description

Heart failure Asymptomatic New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1275491
programmed surgical intervention: valve prosthesis or revascularization
Description

Surgical intervention Scheduled | Prosthetic valve | Revascularization

Data type

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0336548
UMLS CUI [3]
C0581603
impossibility to follow a program of patient education
Description

Patient education Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0030688
UMLS CUI [1,2]
C1272705
residing in medicalized care facility for persons without autonomy
Description

Reside Health care facility

Data type

boolean

Alias
UMLS CUI [1,1]
C2982691
UMLS CUI [1,2]
C0018704
residing outside the recruitment zones
Description

Residence Remote

Data type

boolean

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

Eligibility Heart Failure NCT02135458

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 60 years or more
boolean
C0001779 (UMLS CUI [1])
Coverage Social security system
Item
covered by french social security system or equivalent
boolean
C1551362 (UMLS CUI [1,1])
C2371809 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent signed by patient
boolean
C0021430 (UMLS CUI [1])
Heart failure
Item
heart failure diagnosed by a cardiologue
boolean
C0018801 (UMLS CUI [1])
Stage New York Heart Association Classification
Item
nyha stage ii, iii or iv
boolean
C1306673 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Patient Available Follow-up
Item
able to be followed-up for 1 year
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Participation Education about health care
Item
attend general healthcare education sessions
boolean
C0679823 (UMLS CUI [1,1])
C2095494 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Freedom Restricted Judicial aspects
Item
freedom restricted by judicial order
boolean
C0016694 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0243116 (UMLS CUI [1,3])
Protection of patient Legal
Item
under legal protection
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Peritoneal Dialysis Required | Hemofiltration Required
Item
require peritoneal dialysis or hemofiltration
boolean
C0031139 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019014 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Refusal to Participate Patient | Refusal to Participate Primary Care Physicians | Refusal to Participate Cardiologist
Item
participation refused by patient, primary care physician or cardiologist
boolean
C1136454 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1136454 (UMLS CUI [2,1])
C0033131 (UMLS CUI [2,2])
C1136454 (UMLS CUI [3,1])
C0175906 (UMLS CUI [3,2])
Comorbidity Severe | Poor prognosis short-term
Item
present a severe comorbidity with poor short-term prognosis
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0278252 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
Heart failure Asymptomatic New York Heart Association Classification
Item
present asymptomatic heart failure nyha stage i
boolean
C0018801 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Surgical intervention Scheduled | Prosthetic valve | Revascularization
Item
programmed surgical intervention: valve prosthesis or revascularization
boolean
C0549433 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0336548 (UMLS CUI [2])
C0581603 (UMLS CUI [3])
Patient education Unsuccessful
Item
impossibility to follow a program of patient education
boolean
C0030688 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Reside Health care facility
Item
residing in medicalized care facility for persons without autonomy
boolean
C2982691 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Residence Remote
Item
residing outside the recruitment zones
boolean
C0237096 (UMLS CUI [1,1])
C0205157 (UMLS CUI [1,2])
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