ID

35791

Beskrivning

INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study; ODM derived from: https://clinicaltrials.gov/show/NCT02022111

Länk

https://clinicaltrials.gov/show/NCT02022111

Nyckelord

Versioner (1)
  1. 2019-03-23 2019-03-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT02022111

Engelsk

Eligibility Diabetes NCT02022111

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02022111
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥35 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
Beskrivning

Diabetes | Glucose tolerance test | Glucose measurement Venous Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2]
C0017741
UMLS CUI [3,1]
C0337438
UMLS CUI [3,2]
C0348013
UMLS CUI [3,3]
C1265611
phq-9 score≥10
Beskrivning

PHQ-9

Datatyp

boolean

Alias
UMLS CUI [1]
C4083201
≥1 poorly-controlled cvd risk factor (either hba1c≥8.0% or sbp≥140 mmhg or ldl≥130 mg/dl), irrespective of medications used
Beskrivning

Cardiovascular Disease Risk factors Poorly controlled | Hemoglobin A1c measurement | Systolic Pressure | Low density lipoprotein cholesterol measurement | Independent of Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C3853134
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0202117
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0013227
willingness to consent to randomization.
Beskrivning

Consent Randomization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C0034656
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient reports a "3" on the phq-9 questionnaire suicide item (item no:9) which reflects very high suicide risk or the patient's phq-9 score is above 23 indicating severe depression requiring immediate referral
Beskrivning

Risk suicide Very high PHQ-9 | Severe depression PHQ-9 | Requirement Referral Immediate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0442804
UMLS CUI [1,3]
C4083201
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C4083201
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0034927
UMLS CUI [3,3]
C0205253
any participant reporting a "2" on the phq-9 suicide item (item no:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
Beskrivning

At risk for suicide PHQ-9 | Patient review Accurate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C4083201
UMLS CUI [2,1]
C0451610
UMLS CUI [2,2]
C0443131
already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the mini)
Beskrivning

Psychiatric care | Antipsychotic Agents | Mood Stabilizer | Dementia | Bipolar Disorder | Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0204523
UMLS CUI [2]
C0040615
UMLS CUI [3]
C2917435
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0036341
diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
Beskrivning

Diabetes Secondary to Cause uncommon | Pancreatitis, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0522498
UMLS CUI [2]
C0149521
pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
documented cvd event (mi, stroke) in past 12 months
Beskrivning

Cardiovascular event | Myocardial Infarction | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
end-stage renal disease awaiting transplant
Beskrivning

Kidney Failure, Chronic | Patient awaiting renal transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C3472678
malignancy or life-threatening disease with death probable in 3 years
Beskrivning

Malignant Neoplasms | Life threatening illness | Cessation of life Probable

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C3846017
UMLS CUI [3,1]
C0011065
UMLS CUI [3,2]
C0332148
alcohol or drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
no fixed address or contact details.
Beskrivning

Patient address Lacking | Contact Details Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0421449
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0332158
UMLS CUI [2,2]
C1522508
UMLS CUI [2,3]
C0332268
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Similar models

Eligibility Diabetes NCT02022111

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02022111
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥35 years
boolean
C0001779 (UMLS CUI [1])
Diabetes | Glucose tolerance test | Glucose measurement Venous Quantity
Item
confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
boolean
C0011847 (UMLS CUI [1])
C0017741 (UMLS CUI [2])
C0337438 (UMLS CUI [3,1])
C0348013 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
PHQ-9
Item
phq-9 score≥10
boolean
C4083201 (UMLS CUI [1])
Cardiovascular Disease Risk factors Poorly controlled | Hemoglobin A1c measurement | Systolic Pressure | Low density lipoprotein cholesterol measurement | Independent of Pharmaceutical Preparations
Item
≥1 poorly-controlled cvd risk factor (either hba1c≥8.0% or sbp≥140 mmhg or ldl≥130 mg/dl), irrespective of medications used
boolean
C0007222 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0202117 (UMLS CUI [4])
C0332291 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
Consent Randomization
Item
willingness to consent to randomization.
boolean
C1511481 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Risk suicide Very high PHQ-9 | Severe depression PHQ-9 | Requirement Referral Immediate
Item
the patient reports a "3" on the phq-9 questionnaire suicide item (item no:9) which reflects very high suicide risk or the patient's phq-9 score is above 23 indicating severe depression requiring immediate referral
boolean
C0563664 (UMLS CUI [1,1])
C0442804 (UMLS CUI [1,2])
C4083201 (UMLS CUI [1,3])
C0588008 (UMLS CUI [2,1])
C4083201 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0034927 (UMLS CUI [3,2])
C0205253 (UMLS CUI [3,3])
At risk for suicide PHQ-9 | Patient review Accurate
Item
any participant reporting a "2" on the phq-9 suicide item (item no:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
boolean
C0563664 (UMLS CUI [1,1])
C4083201 (UMLS CUI [1,2])
C0451610 (UMLS CUI [2,1])
C0443131 (UMLS CUI [2,2])
Psychiatric care | Antipsychotic Agents | Mood Stabilizer | Dementia | Bipolar Disorder | Schizophrenia
Item
already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the mini)
boolean
C0204523 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C2917435 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0036341 (UMLS CUI [6])
Diabetes Secondary to Cause uncommon | Pancreatitis, Chronic
Item
diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
boolean
C0011847 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0522498 (UMLS CUI [1,4])
C0149521 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular event | Myocardial Infarction | Cerebrovascular accident
Item
documented cvd event (mi, stroke) in past 12 months
boolean
C1320716 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Kidney Failure, Chronic | Patient awaiting renal transplant
Item
end-stage renal disease awaiting transplant
boolean
C0022661 (UMLS CUI [1])
C3472678 (UMLS CUI [2])
Malignant Neoplasms | Life threatening illness | Cessation of life Probable
Item
malignancy or life-threatening disease with death probable in 3 years
boolean
C0006826 (UMLS CUI [1])
C3846017 (UMLS CUI [2])
C0011065 (UMLS CUI [3,1])
C0332148 (UMLS CUI [3,2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Patient address Lacking | Contact Details Lacking
Item
no fixed address or contact details.
boolean
C0421449 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0332158 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
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