ID

14235

Description

Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT); ODM derived from: https://clinicaltrials.gov/show/NCT00385684

Link

https://clinicaltrials.gov/show/NCT00385684

Keywords

Versions (1)
  1. 4/5/16 4/5/16 -
Uploaded on

April 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00385684

English

Eligibility Alzheimer Disease NCT00385684

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
55 years of age or older;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
must have a diagnosis of dementia;
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
Description

dementia stage

Data type

boolean

Alias
UMLS CUI [1]
C0743034
unable to report pain in a reliable and consistent manner;
Description

pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
Description

painad score

Data type

boolean

the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
Description

medical condition pain

Data type

boolean

Alias
UMLS CUI [1]
C1405025
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the existence of an effective analgesia treatment regimen;
Description

treatment regimen analgesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C3202977
pain treatment related to angina or pain judged to be related to angina;
Description

Pain management; pain angina

Data type

boolean

Alias
UMLS CUI [1]
C0002766
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0002962
current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
Description

Compliance behavior pain therapy opiates

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0002766
UMLS CUI [1,4]
C0376196
current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
Description

Pain management tramadol

Data type

boolean

Alias
UMLS CUI [1,1]
C0002766
UMLS CUI [1,2]
C0040610
presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
Description

concomitant medication hydrocodone acetaminophen

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0020264
UMLS CUI [1,3]
C0000970
a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
Description

hypersensitivity hydrocodone acetaminophen

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020264
UMLS CUI [1,3]
C0000970
constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
Description

constipation

Data type

boolean

Alias
UMLS CUI [1]
C0009806
the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
Description

liver disease; encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0085584
the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
Description

renal failure; serum creatinine levels

Data type

boolean

Alias
UMLS CUI [1]
C1533077
UMLS CUI [2]
C0600061
evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
Description

comorbidity infection fever; geriatrician

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0015967
UMLS CUI [2]
C0586872
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Similar models

Eligibility Alzheimer Disease NCT00385684

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
55 years of age or older;
boolean
C0001779 (UMLS CUI [1])
dementia
Item
must have a diagnosis of dementia;
boolean
C0497327 (UMLS CUI [1])
dementia stage
Item
advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale;
boolean
C0743034 (UMLS CUI [1])
pain
Item
unable to report pain in a reliable and consistent manner;
boolean
C0030193 (UMLS CUI [1])
painad score
Item
have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days;
boolean
medical condition pain
Item
the patient must have at least one medical condition associated with pain recorded on the cprs problem list.
boolean
C1405025 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
treatment regimen analgesia
Item
the existence of an effective analgesia treatment regimen;
boolean
C0040808 (UMLS CUI [1,1])
C3202977 (UMLS CUI [1,2])
Pain management; pain angina
Item
pain treatment related to angina or pain judged to be related to angina;
boolean
C0002766 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0002962 (UMLS CUI [2,2])
Compliance behavior pain therapy opiates
Item
current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0002766 (UMLS CUI [1,3])
C0376196 (UMLS CUI [1,4])
Pain management tramadol
Item
current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued;
boolean
C0002766 (UMLS CUI [1,1])
C0040610 (UMLS CUI [1,2])
concomitant medication hydrocodone acetaminophen
Item
presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen;
boolean
C2347852 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C0000970 (UMLS CUI [1,3])
hypersensitivity hydrocodone acetaminophen
Item
a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen;
boolean
C0020517 (UMLS CUI [1,1])
C0020264 (UMLS CUI [1,2])
C0000970 (UMLS CUI [1,3])
constipation
Item
constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician;
boolean
C0009806 (UMLS CUI [1])
liver disease; encephalopathy
Item
the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician;
boolean
C0023895 (UMLS CUI [1])
C0085584 (UMLS CUI [2])
renal failure; serum creatinine levels
Item
the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or
boolean
C1533077 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
comorbidity infection fever; geriatrician
Item
evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)
boolean
C0009488 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0586872 (UMLS CUI [2])
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