ID

38798

Description

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

Lien

https://clinicaltrials.gov/show/NCT01861756

Mots-clés

Versions (1)
  1. 04/11/2019 04/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 novembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01861756

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT01861756

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Type de données

boolean

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

Agreement Follow-up

Type de données

boolean

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

Survey Completion

Type de données

boolean

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

Hemoglobin A1c measurement

Type de données

boolean

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

Patient need for Intensification therapy | Availability of Treatment options Quantity

Type de données

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
Description

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
Description

Intensification therapy Rejected | Life Style Modification Rejected

Type de données

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
Description

Patient Transfer

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

Lacking Able to speak fluently Greek language

Type de données

boolean

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

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01861756

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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