ID

34819

Description

Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older; ODM derived from: https://clinicaltrials.gov/show/NCT02392754

Link

https://clinicaltrials.gov/show/NCT02392754

Keywords

Versions (1)
  1. 1/30/19 1/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02392754

English

Eligibility Atrial Fibrillation NCT02392754

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥75 years without known atrial fibrillation or atrial flutter.
Description

Age | Atrial Fibrillation Absent | Atrial Flutter Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0004239
UMLS CUI [3,2]
C0332197
2. the participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
Description

Sinus rhythm | Heart Auscultation | Finding of pulse taking by palpation

Data type

boolean

Alias
UMLS CUI [1]
C0232201
UMLS CUI [2]
C0018793
UMLS CUI [3]
C1720373
3. history of hypertension requiring antihypertensive medication.
Description

Hypertensive disease Requiring Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003364
4. written informed consent from the participant.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
Description

Atrial Fibrillation Previous Seconds Quantity | Atrial Flutter Previous Seconds Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0457385
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0004239
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0457385
UMLS CUI [2,4]
C1265611
2. implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
Description

Pacemaker implant | Presence of cardiac defibrillator | Implantable loop recorder present | Deep brain stimulator implant

Data type

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C1391956
UMLS CUI [3]
C3838353
UMLS CUI [4]
C4069029
3. likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.
Description

Protocol Compliance Poor | Impaired cognition | Life Expectancy Due to Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0338656
UMLS CUI [3,1]
C0023671
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0009488
4. has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
Description

Condition Preventing Anticoagulant therapy Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0150457
UMLS CUI [1,4]
C1527415
5. patient already taking long-term oral anticoagulant therapy.
Description

Anticoagulant therapy Oral Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0443252
6. known allergic reaction/intolerance to skin adhesives.
Description

Allergic Reaction Skin tissue adhesive | Intolerance to Skin tissue adhesive

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1714038
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1714038
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Similar models

Eligibility Atrial Fibrillation NCT02392754

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Atrial Fibrillation Absent | Atrial Flutter Absent
Item
1. age ≥75 years without known atrial fibrillation or atrial flutter.
boolean
C0001779 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004239 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Sinus rhythm | Heart Auscultation | Finding of pulse taking by palpation
Item
2. the participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
boolean
C0232201 (UMLS CUI [1])
C0018793 (UMLS CUI [2])
C1720373 (UMLS CUI [3])
Hypertensive disease Requiring Antihypertensive Agents
Item
3. history of hypertension requiring antihypertensive medication.
boolean
C0020538 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
Informed Consent
Item
4. written informed consent from the participant.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Previous Seconds Quantity | Atrial Flutter Previous Seconds Quantity
Item
1. any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
boolean
C0004238 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0457385 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0004239 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0457385 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Pacemaker implant | Presence of cardiac defibrillator | Implantable loop recorder present | Deep brain stimulator implant
Item
2. implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
boolean
C0848753 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
C3838353 (UMLS CUI [3])
C4069029 (UMLS CUI [4])
Protocol Compliance Poor | Impaired cognition | Life Expectancy Due to Comorbidity
Item
3. likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy <6 months due to concomitant disease.
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2])
C0023671 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
Condition Preventing Anticoagulant therapy Oral
Item
4. has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0150457 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
Anticoagulant therapy Oral Long-term
Item
5. patient already taking long-term oral anticoagulant therapy.
boolean
C0150457 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Allergic Reaction Skin tissue adhesive | Intolerance to Skin tissue adhesive
Item
6. known allergic reaction/intolerance to skin adhesives.
boolean
C1527304 (UMLS CUI [1,1])
C1714038 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1714038 (UMLS CUI [2,2])
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