ID

38798

Beschreibung

The Diabetes Medication Choice Cards Trial in Greece; ODM derived from: https://clinicaltrials.gov/show/NCT01861756

Link

https://clinicaltrials.gov/show/NCT01861756

Stichworte

Versionen (1)
  1. 04.11.19 04.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01861756

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01861756

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus for more than one year
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
agree to be followed for at least 6 months
Beschreibung

Agreement Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C3274571
willing to respond to survey questions immediately following the visit
Beschreibung

Survey Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038951
UMLS CUI [1,2]
C0205197
hba1c value between 7.5% and 10%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
need treatment intensification and there are more than one available treatment options
Beschreibung

Patient need for Intensification therapy | Availability of Treatment options Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1511484
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0683525
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
Beschreibung

Intensification therapy Rejected | Life Style Modification Rejected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511484
UMLS CUI [1,2]
C1548437
UMLS CUI [2,1]
C0023676
UMLS CUI [2,2]
C3840684
UMLS CUI [2,3]
C1548437
is to transfer to another practice within the next 6 months
Beschreibung

Patient Transfer

Datentyp

boolean

Alias
UMLS CUI [1]
C0030704
significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
Beschreibung

Impaired cognition | Dementia | Hypesthesia | Blindness | Informed Consent Unable | Use of Decision Aids Unable | Fatigue | Disturbance of attention | Sleep Deprivation

Datentyp

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0020580
UMLS CUI [4]
C0456909
UMLS CUI [5,1]
C0021430
UMLS CUI [5,2]
C1299582
UMLS CUI [6,1]
C1524063
UMLS CUI [6,2]
C0086104
UMLS CUI [6,3]
C1299582
UMLS CUI [7]
C0015672
UMLS CUI [8]
C0233414
UMLS CUI [9]
C0037316
planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
Beschreibung

Long-Term Care Facility Residence Planned | Nursing Home Residence Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708733
UMLS CUI [1,2]
C0237096
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0028688
UMLS CUI [2,2]
C0237096
UMLS CUI [2,3]
C1301732
enrolled in other studies that require prolonged participation and follow-up
Beschreibung

Study Subject Participation Status | Requirement Participation Prolonged | Requirement Follow-up

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0439590
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C3274571
unable to speak greek at a level necessary to complete the patient surveys and ensure involvement in decision making
Beschreibung

Lacking Able to speak fluently Greek language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564241
UMLS CUI [1,3]
C0574315
women known to be pregnant
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01861756

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for more than one year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Agreement Follow-up
Item
agree to be followed for at least 6 months
boolean
C0680240 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
Survey Completion
Item
willing to respond to survey questions immediately following the visit
boolean
C0038951 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c value between 7.5% and 10%
boolean
C0474680 (UMLS CUI [1])
Patient need for Intensification therapy | Availability of Treatment options Quantity
Item
need treatment intensification and there are more than one available treatment options
boolean
C0686904 (UMLS CUI [1,1])
C1511484 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C0683525 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Intensification therapy Rejected | Life Style Modification Rejected
Item
decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
boolean
C1511484 (UMLS CUI [1,1])
C1548437 (UMLS CUI [1,2])
C0023676 (UMLS CUI [2,1])
C3840684 (UMLS CUI [2,2])
C1548437 (UMLS CUI [2,3])
Patient Transfer
Item
is to transfer to another practice within the next 6 months
boolean
C0030704 (UMLS CUI [1])
Impaired cognition | Dementia | Hypesthesia | Blindness | Informed Consent Unable | Use of Decision Aids Unable | Fatigue | Disturbance of attention | Sleep Deprivation
Item
significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
boolean
C0338656 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0020580 (UMLS CUI [3])
C0456909 (UMLS CUI [4])
C0021430 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
C1524063 (UMLS CUI [6,1])
C0086104 (UMLS CUI [6,2])
C1299582 (UMLS CUI [6,3])
C0015672 (UMLS CUI [7])
C0233414 (UMLS CUI [8])
C0037316 (UMLS CUI [9])
Long-Term Care Facility Residence Planned | Nursing Home Residence Planned
Item
planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
boolean
C1708733 (UMLS CUI [1,1])
C0237096 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0028688 (UMLS CUI [2,1])
C0237096 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Study Subject Participation Status | Requirement Participation Prolonged | Requirement Follow-up
Item
enrolled in other studies that require prolonged participation and follow-up
boolean
C2348568 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
Lacking Able to speak fluently Greek language
Item
unable to speak greek at a level necessary to complete the patient surveys and ensure involvement in decision making
boolean
C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0574315 (UMLS CUI [1,3])
Pregnancy
Item
women known to be pregnant
boolean
C0032961 (UMLS CUI [1])
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