ID

40001

Description

CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01416766

Lien

https://clinicaltrials.gov/show/NCT01416766

Mots-clés

Versions (1)
  1. 09/03/2020 09/03/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 mars 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT01416766

Anglais

Eligibility Hypertension NCT01416766

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnoses of both diabetes mellitus (modification 2/13: prediabetes) and hypertension
Description

Diabetes Mellitus | Modification Prediabetes | Hypertensive disease

Type de données

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0579005
UMLS CUI [2,2]
C0362046
UMLS CUI [3]
C0020538
uncontrolled hypertension (mean of up to most recent 3 clinic bps in previous 6 months with sbp>=145 and/or dbp>=85) and mean of 3 readings taken at intake visit meeting same criterion
Description

Uncontrolled hypertension | Blood pressure determination Quantity mean | Systolic Pressure | Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0005824
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0444504
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
end-stage renal disease
Description

Kidney Failure, Chronic

Type de données

boolean

Alias
UMLS CUI [1]
C0022661
management of blood pressure by provider other than primary care provider (pcp)
Description

Blood pressure taking management Provider | Exception Primary care provider

Type de données

boolean

Alias
UMLS CUI [1,1]
C1272452
UMLS CUI [1,2]
C1138603
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2735026
pregnancy/gestational diabetes
Description

Pregnancy | Gestational Diabetes

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085207
terminal illness
Description

Terminal illness

Type de données

boolean

Alias
UMLS CUI [1]
C0679247
diagnosed or probable (based on screen) dementia
Description

Dementia | Dementia Probable

Type de données

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0332148
active psychosis
Description

Psychotic Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0033975
moderate-severe mental retardation
Description

Mental retardation, moderate to severe

Type de données

boolean

Alias
UMLS CUI [1]
C1847353
indication by pcp that patient would be inappropriate for study
Description

Study Subject Participation Status Inappropriate

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
planning to leave reliant medical group (formerly fallon clinic) during the coming year
Description

Medical center Change Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0565990
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C1301732
modifications: due to a smaller pool of eligible participants and lower enrollment than anticipated, eligibility for the study has been expanded as of february 2013 to include persons with "prediabetes," defined by either a coded diagnosis of abnormal glucose (international classification of diseases [icd] 9-cm codes 790.2x) or a hemoglobin a1c laboratory value from 6.0%-6.4%. for this group, the dbp eligibility criterion will be a mean, as defined above, of >=95, as target bp for this group is 140/90, not 140/80.
Description

Modification | Prediabetes | Blood glucose abnormal | Hemoglobin A1c measurement | Diastolic blood pressure mean

Type de données

boolean

Alias
UMLS CUI [1]
C0579005
UMLS CUI [2]
C0362046
UMLS CUI [3]
C0580546
UMLS CUI [4]
C0474680
UMLS CUI [5,1]
C0428883
UMLS CUI [5,2]
C0444504
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Similar models

Eligibility Hypertension NCT01416766

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | Modification Prediabetes | Hypertensive disease
Item
diagnoses of both diabetes mellitus (modification 2/13: prediabetes) and hypertension
boolean
C0011849 (UMLS CUI [1])
C0579005 (UMLS CUI [2,1])
C0362046 (UMLS CUI [2,2])
C0020538 (UMLS CUI [3])
Uncontrolled hypertension | Blood pressure determination Quantity mean | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (mean of up to most recent 3 clinic bps in previous 6 months with sbp>=145 and/or dbp>=85) and mean of 3 readings taken at intake visit meeting same criterion
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0444504 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Kidney Failure, Chronic
Item
end-stage renal disease
boolean
C0022661 (UMLS CUI [1])
Blood pressure taking management Provider | Exception Primary care provider
Item
management of blood pressure by provider other than primary care provider (pcp)
boolean
C1272452 (UMLS CUI [1,1])
C1138603 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2735026 (UMLS CUI [2,2])
Pregnancy | Gestational Diabetes
Item
pregnancy/gestational diabetes
boolean
C0032961 (UMLS CUI [1])
C0085207 (UMLS CUI [2])
Terminal illness
Item
terminal illness
boolean
C0679247 (UMLS CUI [1])
Dementia | Dementia Probable
Item
diagnosed or probable (based on screen) dementia
boolean
C0497327 (UMLS CUI [1])
C0497327 (UMLS CUI [2,1])
C0332148 (UMLS CUI [2,2])
Psychotic Disorder
Item
active psychosis
boolean
C0033975 (UMLS CUI [1])
Mental retardation, moderate to severe
Item
moderate-severe mental retardation
boolean
C1847353 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
indication by pcp that patient would be inappropriate for study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Medical center Change Planned
Item
planning to leave reliant medical group (formerly fallon clinic) during the coming year
boolean
C0565990 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Modification | Prediabetes | Blood glucose abnormal | Hemoglobin A1c measurement | Diastolic blood pressure mean
Item
modifications: due to a smaller pool of eligible participants and lower enrollment than anticipated, eligibility for the study has been expanded as of february 2013 to include persons with "prediabetes," defined by either a coded diagnosis of abnormal glucose (international classification of diseases [icd] 9-cm codes 790.2x) or a hemoglobin a1c laboratory value from 6.0%-6.4%. for this group, the dbp eligibility criterion will be a mean, as defined above, of >=95, as target bp for this group is 140/90, not 140/80.
boolean
C0579005 (UMLS CUI [1])
C0362046 (UMLS CUI [2])
C0580546 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0428883 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
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