ID

37190

Description

Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices; ODM derived from: https://clinicaltrials.gov/show/NCT01430936 Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system. Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.

Link

https://clinicaltrials.gov/show/NCT01430936

Keywords

Versions (1)
  1. 7/7/19 7/7/19 -
Copyright Holder

Aventyn, Inc.

Uploaded on

July 7, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Evaluate Heart Failure Patients with Mobile Device Software NCT01430936

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant above the age of 18 years?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Is the participant able and willing to provide written informed consent prior to enrollment in the study?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C0600109
UMLS CUI [2,2]
C0021430
Does the participant have a New York Heart Association (nyha) classification class of II-IV?
Description

NYHA II-IV

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C1536131
UMLS CUI [3]
C1536132
UMLS CUI [4]
C1536133
Does the participant have a left ventricular ejection fraction (LVEF) less than 40%?
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Does the participant have one or more prior hospitalization within the last six months for symptoms, management of heart failure?
Description

Heart failure hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have disability of fingers or upper limbs (unable to use devices)?
Description

Upper limb disability

Data type

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C1140618
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C0016129
Is the participant visually impaired?
Description

Visual Impairment

Data type

boolean

Alias
UMLS CUI [1]
C3665347
Is the participant unable to read and write?
Description

Inability to read and write

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0034754
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C2584304
Does the participant have a hearing dysfunction?
Description

Hearing dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0260662
Does the participant have significant cognitive disabilities, mental illness?
Description

Cognitive Disabilities/Mental Illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0750502
UMLS CUI [1,2]
C4747803
UMLS CUI [2,1]
C0750502
UMLS CUI [2,2]
C0004936
Is the participant unable to handle electronic devices?
Description

Inability to handle electronic devices

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0013850
UMLS CUI [1,4]
C0699733
Is the participant residing in places outside the local mobile phone coverage?
Description

Living outside local mobile phone coverage

Data type

boolean

Alias
UMLS CUI [1,1]
C4520849
UMLS CUI [1,2]
C0205101
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C1136360
UMLS CUI [1,5]
C0439844
Does the participant have chronic renal failure on renal replacement therapy?
Description

Chronic renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0206074
Does the participant may not come for follow up or is likely to drop out of the study?
Description

Follow-Up Problems

Data type

boolean

Alias
UMLS CUI [1,1]
C3844350
UMLS CUI [1,2]
C0420315
UMLS CUI [2,1]
C3844350
UMLS CUI [2,2]
C4554109
Is the participant awaiting cardiac transplantation?
Description

Awaiting cardiac transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C4520458
UMLS CUI [1,2]
C0018787
Does the participant have any illness which may preclude regular follow up?
Description

Illness precluding follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1522577
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant above the age of 18 years?
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Is the participant able and willing to provide written informed consent prior to enrollment in the study?
boolean
C0085732 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0600109 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
NYHA II-IV
Item
Does the participant have a New York Heart Association (nyha) classification class of II-IV?
boolean
C1275491 (UMLS CUI [1])
C1536131 (UMLS CUI [2])
C1536132 (UMLS CUI [3])
C1536133 (UMLS CUI [4])
LVEF
Item
Does the participant have a left ventricular ejection fraction (LVEF) less than 40%?
boolean
C0428772 (UMLS CUI [1])
Heart failure hospitalization
Item
Does the participant have one or more prior hospitalization within the last six months for symptoms, management of heart failure?
boolean
C0332185 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Upper limb disability
Item
Does the participant have disability of fingers or upper limbs (unable to use devices)?
boolean
C0231170 (UMLS CUI [1,1])
C1140618 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C0016129 (UMLS CUI [2,2])
Visual Impairment
Item
Is the participant visually impaired?
boolean
C3665347 (UMLS CUI [1])
Inability to read and write
Item
Is the participant unable to read and write?
boolean
C1299582 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C2584304 (UMLS CUI [2,2])
Hearing dysfunction
Item
Does the participant have a hearing dysfunction?
boolean
C0260662 (UMLS CUI [1])
Cognitive Disabilities/Mental Illness
Item
Does the participant have significant cognitive disabilities, mental illness?
boolean
C0750502 (UMLS CUI [1,1])
C4747803 (UMLS CUI [1,2])
C0750502 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
Inability to handle electronic devices
Item
Is the participant unable to handle electronic devices?
boolean
C1299582 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0013850 (UMLS CUI [1,3])
C0699733 (UMLS CUI [1,4])
Living outside local mobile phone coverage
Item
Is the participant residing in places outside the local mobile phone coverage?
boolean
C4520849 (UMLS CUI [1,1])
C0205101 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1136360 (UMLS CUI [1,4])
C0439844 (UMLS CUI [1,5])
Chronic renal failure
Item
Does the participant have chronic renal failure on renal replacement therapy?
boolean
C0022661 (UMLS CUI [1])
C0206074 (UMLS CUI [2])
Follow-Up Problems
Item
Does the participant may not come for follow up or is likely to drop out of the study?
boolean
C3844350 (UMLS CUI [1,1])
C0420315 (UMLS CUI [1,2])
C3844350 (UMLS CUI [2,1])
C4554109 (UMLS CUI [2,2])
Awaiting cardiac transplantation
Item
Is the participant awaiting cardiac transplantation?
boolean
C4520458 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Illness precluding follow-up
Item
Does the participant have any illness which may preclude regular follow up?
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
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