ID

39015

Description

Changing the Healthcare Delivery Model; ODM derived from: https://clinicaltrials.gov/show/NCT02093234

Link

https://clinicaltrials.gov/show/NCT02093234

Keywords

Versions (1)
  1. 11/20/19 11/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT02093234

English

Eligibility Diabetes Type 2 NCT02093234

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 21 to 75 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
medicaid insurance coverage, medicare insurance coverage or affordable health care act insurance coverage
Description

Medical insurance coverage | Medicare Insurance Coverage

Data type

boolean

Alias
UMLS CUI [1]
C2136534
UMLS CUI [2,1]
C0018717
UMLS CUI [2,2]
C0376629
fluent in english or spanish and able to read a text message
Description

Ability to speak fluently English Language | Ability to speak fluently Spanish Language | Able to read Text Messages

Data type

boolean

Alias
UMLS CUI [1,1]
C0564240
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564240
UMLS CUI [2,2]
C0037750
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C3178910
diagnosed with diabetes mellitus type 2 and a1c is > 8%
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
acceptable values will be either :
Description

Laboratory Results Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
a1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
a new a1c measured at the baseline screening visit.
Description

Hemoglobin A1c measurement New

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0205314
meets < 10 of the wellness behaviors and clinical goals if diagnosed with hypertension meets < 9 of the wellness behaviors and clinical goals if not diagnosed with hypertension
Description

Health behaviors Quantity Fulfill | Goals Clinical Quantity Fulfill | Hypertensive disease | Hypertensive disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018687
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0018017
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1550543
UMLS CUI [3]
C0020538
UMLS CUI [4,1]
C0020538
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage 5 chronic kidney disease or end stage renal disease on dialysis
Description

Chronic kidney disease stage | Kidney Failure, Chronic | Dialysis procedure

Data type

boolean

Alias
UMLS CUI [1]
C2074731
UMLS CUI [2]
C0022661
UMLS CUI [3]
C0011946
terminal illness (expected survival of less than one year)
Description

Terminal illness | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0023671
severe dementia or uncontrolled mental illness
Description

Severe dementia | Mental disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C3494652
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
gestational diabetes mellitus
Description

Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0085207
use of an insulin pump
Description

Insulin pump

Data type

boolean

Alias
UMLS CUI [1]
C1140609
inability to use a cellular phone
Description

Use of Cellular Phone Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1136359
UMLS CUI [1,3]
C1299582
unable to use software application on cellular phone
Description

Use of Application program software Cellular Phone Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3873651
UMLS CUI [1,3]
C1136359
UMLS CUI [1,4]
C1299582
pregnant or planning to get pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Diabetes Type 2 NCT02093234

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 21 to 75 years old
boolean
C0001779 (UMLS CUI [1])
Medical insurance coverage | Medicare Insurance Coverage
Item
medicaid insurance coverage, medicare insurance coverage or affordable health care act insurance coverage
boolean
C2136534 (UMLS CUI [1])
C0018717 (UMLS CUI [2,1])
C0376629 (UMLS CUI [2,2])
Ability to speak fluently English Language | Ability to speak fluently Spanish Language | Able to read Text Messages
Item
fluent in english or spanish and able to read a text message
boolean
C0564240 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564240 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
C0586740 (UMLS CUI [3,1])
C3178910 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
diagnosed with diabetes mellitus type 2 and a1c is > 8%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Laboratory Results Acceptable
Item
acceptable values will be either :
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
a1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or
boolean
C0474680 (UMLS CUI [1])
Hemoglobin A1c measurement New
Item
a new a1c measured at the baseline screening visit.
boolean
C0474680 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Health behaviors Quantity Fulfill | Goals Clinical Quantity Fulfill | Hypertensive disease | Hypertensive disease Absent
Item
meets < 10 of the wellness behaviors and clinical goals if diagnosed with hypertension meets < 9 of the wellness behaviors and clinical goals if not diagnosed with hypertension
boolean
C0018687 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0018017 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1550543 (UMLS CUI [2,4])
C0020538 (UMLS CUI [3])
C0020538 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Chronic kidney disease stage | Kidney Failure, Chronic | Dialysis procedure
Item
stage 5 chronic kidney disease or end stage renal disease on dialysis
boolean
C2074731 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Terminal illness | Life Expectancy
Item
terminal illness (expected survival of less than one year)
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Severe dementia | Mental disorder Uncontrolled
Item
severe dementia or uncontrolled mental illness
boolean
C3494652 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Gestational Diabetes
Item
gestational diabetes mellitus
boolean
C0085207 (UMLS CUI [1])
Insulin pump
Item
use of an insulin pump
boolean
C1140609 (UMLS CUI [1])
Use of Cellular Phone Unable
Item
inability to use a cellular phone
boolean
C1524063 (UMLS CUI [1,1])
C1136359 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Use of Application program software Cellular Phone Unable
Item
unable to use software application on cellular phone
boolean
C1524063 (UMLS CUI [1,1])
C3873651 (UMLS CUI [1,2])
C1136359 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to get pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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