ID

30811

Beskrivning

Home-Based Assessment for Alzheimer Disease Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT00546767

Länk

https://clinicaltrials.gov/show/NCT00546767

Nyckelord

Versioner (1)
  1. 2018-06-21 2018-06-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Mild Cognitive Impairment NCT00546767

Engelsk

Eligibility Mild Cognitive Impairment NCT00546767

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 75 and older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
willing to sign consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
willing to take multi-vitamins provided by the study
Beskrivning

Multivitamin preparation Study Protocol Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0301532
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0600109
minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
Beskrivning

Computer Skills Minimal | Learning Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009622
UMLS CUI [1,2]
C0678856
UMLS CUI [1,3]
C0547040
UMLS CUI [2,1]
C0023185
UMLS CUI [2,2]
C0600109
english fluency
Beskrivning

Able to speak fluently English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
mmse greater than 26
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
able to answer and dial a telephone
Beskrivning

Able to dial numbers and answer calls

Datatyp

boolean

Alias
UMLS CUI [1]
C3845404
able to complete the in-person assessment
Beskrivning

Person Assessment Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0205197
able to complete the computerized assessment including adequate speech, hearing and vision
Beskrivning

Speech Assessment Completion Computer | Hearing Assessment Completion Computer | Vision Assessment Completion Computer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037817
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C0009622
UMLS CUI [2,1]
C0018767
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0009622
UMLS CUI [3,1]
C0042789
UMLS CUI [3,2]
C1516048
UMLS CUI [3,3]
C0205197
UMLS CUI [3,4]
C0009622
independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures
Beskrivning

Adult Independent Living | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0021189
UMLS CUI [2]
C0525058
participation of a study partner is desirable and encouraged, but not required
Beskrivning

Participation Clinical Trial Partner

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C3887537
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
dementia
Beskrivning

Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
use of prescription cognitive-enhancing drugs at entry (e.g. aricept, razadyne, exelon, namenda)
Beskrivning

Nootropic Agents | Aricept | Razadyne | Exelon | Namenda

Datatyp

boolean

Alias
UMLS CUI [1]
C0242913
UMLS CUI [2]
C0527315
UMLS CUI [3]
C0939465
UMLS CUI [4]
C0730987
UMLS CUI [5]
C1330412
intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
Beskrivning

Multivitamin preparation Patient Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0301532
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0205369
history or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, parkinson's disease, multiple sclerosis or huntington's disease. transient ischemic attack (tia) is acceptable if over 6 months ago
Beskrivning

Mental condition Major Associated with Impaired cognition | Nervous system disorder Major Associated with Impaired cognition | Neurodegenerative Disorder Major Associated with Impaired cognition | Cerebrovascular accident Major | Parkinson Disease | Multiple Sclerosis | Huntington Disease | Transient Ischemic Attack Previous Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0338656
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0338656
UMLS CUI [3,1]
C0524851
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C0338656
UMLS CUI [4,1]
C0038454
UMLS CUI [4,2]
C0205164
UMLS CUI [5]
C0030567
UMLS CUI [6]
C0026769
UMLS CUI [7]
C0020179
UMLS CUI [8,1]
C0007787
UMLS CUI [8,2]
C0205156
UMLS CUI [8,3]
C1879533
medical conditions associated with life expectancy of less than 5 years
Beskrivning

Medical condition Associated with Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023671
transient domicile interfering with ability to collect study-related data
Beskrivning

Residence Transitory Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0205374
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
current participation in a clinical trial involving central nervous system (cns) medications or cognitive testing that would interfere with the current protocol (participation in uniform data set (uds) assessments by an adc is permitted)
Beskrivning

Study Subject Participation Status | Involvement with Central Nervous System Agents | Involvement with Testing Cognitive | Interference Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0007680
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0039593
UMLS CUI [3,3]
C1516691
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C2348563
cohabitation with another participant in this particular study
Beskrivning

Study Subject Participation Status | Cohabitation Clinical trial participant Other

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0221179
UMLS CUI [2,2]
C1997894
UMLS CUI [2,3]
C0205394
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Similar models

Eligibility Mild Cognitive Impairment NCT00546767

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 75 and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
willing to sign consent
boolean
C0021430 (UMLS CUI [1])
Multivitamin preparation Study Protocol Willing
Item
willing to take multi-vitamins provided by the study
boolean
C0301532 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Computer Skills Minimal | Learning Willing
Item
minimal computer skills or willingness to learn (as demonstrated by completion during screening of a demonstration module for each arm)
boolean
C0009622 (UMLS CUI [1,1])
C0678856 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0023185 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Able to speak fluently English Language
Item
english fluency
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Mini-mental state examination
Item
mmse greater than 26
boolean
C0451306 (UMLS CUI [1])
Able to dial numbers and answer calls
Item
able to answer and dial a telephone
boolean
C3845404 (UMLS CUI [1])
Person Assessment Completion
Item
able to complete the in-person assessment
boolean
C0027361 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Speech Assessment Completion Computer | Hearing Assessment Completion Computer | Vision Assessment Completion Computer
Item
able to complete the computerized assessment including adequate speech, hearing and vision
boolean
C0037817 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0009622 (UMLS CUI [1,4])
C0018767 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0009622 (UMLS CUI [2,4])
C0042789 (UMLS CUI [3,1])
C1516048 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0009622 (UMLS CUI [3,4])
Adult Independent Living | Protocol Compliance
Item
independently living adults, defined as living in a setting in which the participant can ensure access to the resources for study procedures
boolean
C0001675 (UMLS CUI [1,1])
C0021189 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Participation Clinical Trial Partner
Item
participation of a study partner is desirable and encouraged, but not required
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C3887537 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Dementia
Item
dementia
boolean
C0497327 (UMLS CUI [1])
Nootropic Agents | Aricept | Razadyne | Exelon | Namenda
Item
use of prescription cognitive-enhancing drugs at entry (e.g. aricept, razadyne, exelon, namenda)
boolean
C0242913 (UMLS CUI [1])
C0527315 (UMLS CUI [2])
C0939465 (UMLS CUI [3])
C0730987 (UMLS CUI [4])
C1330412 (UMLS CUI [5])
Multivitamin preparation Patient Specific
Item
intent to continue use of own multi-vitamins (for the duration of the study participants must agree to take only study-distributed multi-vitamins)
boolean
C0301532 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Mental condition Major Associated with Impaired cognition | Nervous system disorder Major Associated with Impaired cognition | Neurodegenerative Disorder Major Associated with Impaired cognition | Cerebrovascular accident Major | Parkinson Disease | Multiple Sclerosis | Huntington Disease | Transient Ischemic Attack Previous Acceptable
Item
history or presence of major psychiatric, neurological or neurodegenerative conditions associated with significant cognitive impairment such as major stroke, parkinson's disease, multiple sclerosis or huntington's disease. transient ischemic attack (tia) is acceptable if over 6 months ago
boolean
C3840291 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0338656 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0338656 (UMLS CUI [2,4])
C0524851 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C0338656 (UMLS CUI [3,4])
C0038454 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0030567 (UMLS CUI [5])
C0026769 (UMLS CUI [6])
C0020179 (UMLS CUI [7])
C0007787 (UMLS CUI [8,1])
C0205156 (UMLS CUI [8,2])
C1879533 (UMLS CUI [8,3])
Medical condition Associated with Life Expectancy
Item
medical conditions associated with life expectancy of less than 5 years
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Residence Transitory Interferes with Protocol Compliance
Item
transient domicile interfering with ability to collect study-related data
boolean
C0237096 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Study Subject Participation Status | Involvement with Central Nervous System Agents | Involvement with Testing Cognitive | Interference Study Protocol
Item
current participation in a clinical trial involving central nervous system (cns) medications or cognitive testing that would interfere with the current protocol (participation in uniform data set (uds) assessments by an adc is permitted)
boolean
C2348568 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0007680 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
C1516691 (UMLS CUI [3,3])
C0521102 (UMLS CUI [4,1])
C2348563 (UMLS CUI [4,2])
Study Subject Participation Status | Cohabitation Clinical trial participant Other
Item
cohabitation with another participant in this particular study
boolean
C2348568 (UMLS CUI [1])
C0221179 (UMLS CUI [2,1])
C1997894 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
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