ID

35941

Description

Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02391987

Lien

https://clinicaltrials.gov/show/NCT02391987

Mots-clés

Versions (1)
  1. 05/04/2019 05/04/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

5 avril 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02391987

Anglais

Eligibility Heart Failure NCT02391987

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hospitalized with primary or secondary diagnosis of acute decompensated heart failure (one or more of these symptoms: shortness of breath, orthopnea or edema and one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
Description

Hospitalization Decompensated cardiac failure Primary | Hospitalization Decompensated cardiac failure Secondary | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Signs Quantity | Rales | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest radiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0581377
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0581377
UMLS CUI [2,3]
C0175668
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0085619
UMLS CUI [6]
C0013604
UMLS CUI [7,1]
C0311392
UMLS CUI [7,2]
C1265611
UMLS CUI [8]
C0034642
UMLS CUI [9]
C0085649
UMLS CUI [10]
C0003962
UMLS CUI [11,1]
C0242073
UMLS CUI [11,2]
C1801960
UMLS CUI [11,3]
C0039985
adult patients >18 years old
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
overall life expectancy < 1 year
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
Description

Cutaneous hypersensitivity Hydrocolloid Adhesives | Cutaneous hypersensitivity Silicone adhesive | Cutaneous hypersensitivity Adhesives Acrylic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0585186
UMLS CUI [1,2]
C0001516
UMLS CUI [1,3]
C0020266
UMLS CUI [2,1]
C0585186
UMLS CUI [2,2]
C1576751
UMLS CUI [3,1]
C0585186
UMLS CUI [3,2]
C0001516
UMLS CUI [3,3]
C0440181
active systemic infection
Description

Sepsis

Type de données

boolean

Alias
UMLS CUI [1]
C0243026
pregnant or lactating
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
end stage renal disease on dialysis
Description

Kidney Failure, Chronic | Dialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0011946
subject or caregiver is not visually and tactile capable of smartphone and home device usage
Description

Use of Smartphone Unable | Use of Home Device Unable | Caregiver Smartphone Unable | Caregiver Home Device Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3204335
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0442519
UMLS CUI [2,3]
C0699733
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0085537
UMLS CUI [3,2]
C3204335
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0085537
UMLS CUI [4,2]
C0442519
UMLS CUI [4,3]
C0699733
UMLS CUI [4,4]
C1299582
inadequate cell phone coverage (including international patients or international travel during study period)
Description

Cell Phone Inadequate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1136359
UMLS CUI [1,2]
C0205412
subject or legal guardian is not willing and able to provide appropriate informed consent
Description

Informed Consent Unwilling | Informed Consent Unable | Legal Guardian Informed Consent Unwilling | Legal Guardian Informed Consent Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0023226
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0023226
UMLS CUI [4,2]
C0021430
UMLS CUI [4,3]
C1299582
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Similar models

Eligibility Heart Failure NCT02391987

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Decompensated cardiac failure Primary | Hospitalization Decompensated cardiac failure Secondary | Symptoms Quantity | Dyspnea | Orthopnea | Edema | Signs Quantity | Rales | Peripheral edema | Ascites | Pulmonary congestion Vascular Chest radiography
Item
hospitalized with primary or secondary diagnosis of acute decompensated heart failure (one or more of these symptoms: shortness of breath, orthopnea or edema and one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
boolean
C0019993 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0581377 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0013404 (UMLS CUI [4])
C0085619 (UMLS CUI [5])
C0013604 (UMLS CUI [6])
C0311392 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0034642 (UMLS CUI [8])
C0085649 (UMLS CUI [9])
C0003962 (UMLS CUI [10])
C0242073 (UMLS CUI [11,1])
C1801960 (UMLS CUI [11,2])
C0039985 (UMLS CUI [11,3])
Adult | Age
Item
adult patients >18 years old
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
overall life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Cutaneous hypersensitivity Hydrocolloid Adhesives | Cutaneous hypersensitivity Silicone adhesive | Cutaneous hypersensitivity Adhesives Acrylic
Item
known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
boolean
C0585186 (UMLS CUI [1,1])
C0001516 (UMLS CUI [1,2])
C0020266 (UMLS CUI [1,3])
C0585186 (UMLS CUI [2,1])
C1576751 (UMLS CUI [2,2])
C0585186 (UMLS CUI [3,1])
C0001516 (UMLS CUI [3,2])
C0440181 (UMLS CUI [3,3])
Sepsis
Item
active systemic infection
boolean
C0243026 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Kidney Failure, Chronic | Dialysis
Item
end stage renal disease on dialysis
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Use of Smartphone Unable | Use of Home Device Unable | Caregiver Smartphone Unable | Caregiver Home Device Unable
Item
subject or caregiver is not visually and tactile capable of smartphone and home device usage
boolean
C1524063 (UMLS CUI [1,1])
C3204335 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0442519 (UMLS CUI [2,2])
C0699733 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0085537 (UMLS CUI [3,1])
C3204335 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0085537 (UMLS CUI [4,1])
C0442519 (UMLS CUI [4,2])
C0699733 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
Cell Phone Inadequate
Item
inadequate cell phone coverage (including international patients or international travel during study period)
boolean
C1136359 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Informed Consent Unwilling | Informed Consent Unable | Legal Guardian Informed Consent Unwilling | Legal Guardian Informed Consent Unable
Item
subject or legal guardian is not willing and able to provide appropriate informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0023226 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0023226 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
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