ID

15125

Description

A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians; ODM derived from: https://clinicaltrials.gov/show/NCT02266576

Link

https://clinicaltrials.gov/show/NCT02266576

Keywords

Versions (1)
  1. 5/17/16 5/17/16 -
Uploaded on

May 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02266576

English

Eligibility Diabetes Mellitus, Type 2 NCT02266576

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
self-identified urban aian men and women
Description

North American Indian and Eskimo-Aleuts Alaskan Native American Urban

Data type

boolean

Alias
UMLS CUI [1,1]
C0683981
UMLS CUI [1,2]
C0597091
UMLS CUI [1,3]
C2700386
bmi between 30-55
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
not diagnosed with type ii diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
at least one of the following criterion
Description

One criteria Following

Data type

boolean

Alias
UMLS CUI [1,1]
C0205447
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0332282
1. triglycerides: 150mg/dl or higher
Description

Triglycerides

Data type

boolean

Alias
UMLS CUI [1]
C0041004
2. reduced hdl: <40mg/dl (men); <50mg/dl (women)
Description

Reduced high-density lipoprotein

Data type

boolean

Alias
UMLS CUI [1]
C3808076
3. blood pressure: >130/80 or current treatment with antihypertensives
Description

Blood Pressure | Current Therapy Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2,1]
C2827774
UMLS CUI [2,2]
C0003364
4. fasting glucose: >100mg/dl
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
Description

Comorbidity | Metabolic Diseases Uncontrolled | Thyroid Diseases | Diabetes Mellitus | Kidney Diseases | Liver diseases | Heart Diseases Unstable status | Heart failure | Chronic drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0025517
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0040128
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0443343
UMLS CUI [8]
C0018801
UMLS CUI [9]
C0743244
on greater than 10 prescription medications.
Description

Prescription medications

Data type

boolean

Alias
UMLS CUI [1]
C3843193
psychiatric disorders requiring atypical antipsychotics or multiple medications;
Description

Mental disorders | Atypical antipsychotic | Pharmaceutical Preparations Multiple

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C1276996
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0439064
inappropriate for moderate exercise according to the revised physical activity readiness questionnaire;
Description

Inappropriate Moderate Exercise | Physical activity Readiness Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C1548788
UMLS CUI [1,2]
C1513375
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C1318963
UMLS CUI [2,3]
C0034394
pregnant, planning to become pregnant, or lactating;
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
family household member already enrolled in the study;
Description

Study Subject Participation Status | Family member Enrollment in clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0086282
UMLS CUI [2,2]
C4041024
already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;
Description

Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
resident of a long term care facility;
Description

Resident Health care facility Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0018704
UMLS CUI [1,3]
C0443252
lack of spoken english by patient or a household member > 18 y who can serve as interpreter;
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
plans to move during the study period (9 months post-randomization);
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Description

Compliance behavior Limited | Housing Unstable status | Chronic pain

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0020056
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0150055
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02266576

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
North American Indian and Eskimo-Aleuts Alaskan Native American Urban
Item
self-identified urban aian men and women
boolean
C0683981 (UMLS CUI [1,1])
C0597091 (UMLS CUI [1,2])
C2700386 (UMLS CUI [1,3])
Body mass index
Item
bmi between 30-55
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
not diagnosed with type ii diabetes
boolean
C0011860 (UMLS CUI [1])
One criteria Following
Item
at least one of the following criterion
boolean
C0205447 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
Triglycerides
Item
1. triglycerides: 150mg/dl or higher
boolean
C0041004 (UMLS CUI [1])
Reduced high-density lipoprotein
Item
2. reduced hdl: <40mg/dl (men); <50mg/dl (women)
boolean
C3808076 (UMLS CUI [1])
Blood Pressure | Current Therapy Antihypertensive Agents
Item
3. blood pressure: >130/80 or current treatment with antihypertensives
boolean
C0005823 (UMLS CUI [1])
C2827774 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
Glucose measurement, fasting
Item
4. fasting glucose: >100mg/dl
boolean
C0202045 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity | Metabolic Diseases Uncontrolled | Thyroid Diseases | Diabetes Mellitus | Kidney Diseases | Liver diseases | Heart Diseases Unstable status | Heart failure | Chronic drug abuse
Item
significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
boolean
C0009488 (UMLS CUI [1])
C0025517 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0040128 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0018799 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0018801 (UMLS CUI [8])
C0743244 (UMLS CUI [9])
Prescription medications
Item
on greater than 10 prescription medications.
boolean
C3843193 (UMLS CUI [1])
Mental disorders | Atypical antipsychotic | Pharmaceutical Preparations Multiple
Item
psychiatric disorders requiring atypical antipsychotics or multiple medications;
boolean
C0004936 (UMLS CUI [1])
C1276996 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
Inappropriate Moderate Exercise | Physical activity Readiness Questionnaire
Item
inappropriate for moderate exercise according to the revised physical activity readiness questionnaire;
boolean
C1548788 (UMLS CUI [1,1])
C1513375 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C1318963 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant, or lactating;
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Study Subject Participation Status | Family member Enrollment in clinical trial
Item
family household member already enrolled in the study;
boolean
C2348568 (UMLS CUI [1])
C0086282 (UMLS CUI [2,1])
C4041024 (UMLS CUI [2,2])
Study Subject Participation Status Limited
Item
already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Resident Health care facility Long-term
Item
resident of a long term care facility;
boolean
C2347958 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Lacking Able to speak English Language
Item
lack of spoken english by patient or a household member > 18 y who can serve as interpreter;
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Relocation of home Planned
Item
plans to move during the study period (9 months post-randomization);
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Compliance behavior Limited | Housing Unstable status | Chronic pain
Item
investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0020056 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0150055 (UMLS CUI [3])
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