ID

40330

Beskrivning

Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries; ODM derived from: https://clinicaltrials.gov/show/NCT02111226

Länk

https://clinicaltrials.gov/show/NCT02111226

Nyckelord

Versioner (1)
  1. 2020-04-09 2020-04-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 april 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT02111226

Engelsk

Eligibility Hypertension NCT02111226

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hypertension
Beskrivning

Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
bp > 140/90 mmhg or > 130/80 mmhg if patient has diabetes at the initial screening visit using an approved automated bp monitor.
Beskrivning

Blood pressure determination Blood pressure monitoring | Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0026426
UMLS CUI [2]
C0011849
if on drug therapy, continuous drug therapy with the same dosing interval for 8 weeks prior to and throughout the screening period. may be drug naive.
Beskrivning

Pharmacotherapy | Dosage Interval unchanged | Pharmaceutical Preparations Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1272706
UMLS CUI [2,3]
C0442739
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332197
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
hypertension for at least 12 weeks before screening and throughout the screening period (according to the patient or their medical practitioner)
Beskrivning

Hypertensive disease Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0872146
must have a cell phone plan (in canada) and be willing to maintain the plan during the study. for tanzania, must have a cell phone under a locally available tanzanian carrier.
Beskrivning

Cellular Phone Plan | Availability of Cellular Phone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1136359
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1136359
must be willing to take occasional local calls from study team members
Beskrivning

Telephone call Staff Member allowing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C1552089
UMLS CUI [1,3]
C0683607
one or more of bmi > 30 kg/m2, diabetes, smoking, over age 40, previous history of cad including stroke and heart attack
Beskrivning

Body mass index Number of occurrences | Diabetes Mellitus | Tobacco use | Age | Coronary Artery Disease | Cerebrovascular accident | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0449789
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0543414
UMLS CUI [4]
C0001779
UMLS CUI [5]
C1956346
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0027051
an identified health care provider in the community (ie. family physician/nurse practitioner in canada or community nurse/clinical officer in tanzania)
Beskrivning

Health care provider Identified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018724
UMLS CUI [1,2]
C0205396
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
change in antihypertensive medication during the 8 weeks before enrolment
Beskrivning

Antihypertensive Agents Change

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0392747
no cell phone plan compatible with the study.
Beskrivning

Cellular Phone Plan Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1136359
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0332268
poorly controlled hypertension with bp > 180/110 mmhg
Beskrivning

Poor hypertension control | Blood pressure determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0005824
no primary health care provider
Beskrivning

Primary care provider Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2735026
UMLS CUI [1,2]
C0332268
active malignant disease (except non-melanoma skin cancer)
Beskrivning

Malignant disease | Exception Skin carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
unable or unwilling to visit health care provider
Beskrivning

Health care provider Visit Unable | Health care provider Visit Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018724
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0018724
UMLS CUI [2,2]
C0545082
UMLS CUI [2,3]
C0558080
unable to read the sms messages (english in canada and kiswahili in tanzania)
Beskrivning

Lacking Able to read Text Messages | Lacking Able to read English Language | Lacking Able to read Swahili language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C3178910
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0586740
UMLS CUI [3,3]
C0038977
participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
Beskrivning

Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Therapeutic procedure Recent

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0332185
planned elective surgery during the study period except for cataract surgery
Beskrivning

Elective Surgical Procedure Planned | Exception Cataract surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2939459
*for bp screening study, must not be on an antihypertensive in the last 6 months.
Beskrivning

Absence Antihypertensive Agents Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0003364
UMLS CUI [1,3]
C0332185
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Similar models

Eligibility Hypertension NCT02111226

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease
Item
hypertension
boolean
C0020538 (UMLS CUI [1])
Blood pressure determination Blood pressure monitoring | Diabetes Mellitus
Item
bp > 140/90 mmhg or > 130/80 mmhg if patient has diabetes at the initial screening visit using an approved automated bp monitor.
boolean
C0005824 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
Pharmacotherapy | Dosage Interval unchanged | Pharmaceutical Preparations Absent
Item
if on drug therapy, continuous drug therapy with the same dosing interval for 8 weeks prior to and throughout the screening period. may be drug naive.
boolean
C0013216 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Hypertensive disease Disease length
Item
hypertension for at least 12 weeks before screening and throughout the screening period (according to the patient or their medical practitioner)
boolean
C0020538 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Cellular Phone Plan | Availability of Cellular Phone
Item
must have a cell phone plan (in canada) and be willing to maintain the plan during the study. for tanzania, must have a cell phone under a locally available tanzanian carrier.
boolean
C1136359 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1136359 (UMLS CUI [2,2])
Telephone call Staff Member allowing
Item
must be willing to take occasional local calls from study team members
boolean
C0302186 (UMLS CUI [1,1])
C1552089 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Body mass index Number of occurrences | Diabetes Mellitus | Tobacco use | Age | Coronary Artery Disease | Cerebrovascular accident | Myocardial Infarction
Item
one or more of bmi > 30 kg/m2, diabetes, smoking, over age 40, previous history of cad including stroke and heart attack
boolean
C1305855 (UMLS CUI [1,1])
C0449789 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0543414 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C1956346 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
Health care provider Identified
Item
an identified health care provider in the community (ie. family physician/nurse practitioner in canada or community nurse/clinical officer in tanzania)
boolean
C0018724 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Change
Item
change in antihypertensive medication during the 8 weeks before enrolment
boolean
C0003364 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Cellular Phone Plan Lacking
Item
no cell phone plan compatible with the study.
boolean
C1136359 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Poor hypertension control | Blood pressure determination
Item
poorly controlled hypertension with bp > 180/110 mmhg
boolean
C0421190 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Primary care provider Lacking
Item
no primary health care provider
boolean
C2735026 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Malignant disease | Exception Skin carcinoma
Item
active malignant disease (except non-melanoma skin cancer)
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Health care provider Visit Unable | Health care provider Visit Unwilling
Item
unable or unwilling to visit health care provider
boolean
C0018724 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0018724 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Lacking Able to read Text Messages | Lacking Able to read English Language | Lacking Able to read Swahili language
Item
unable to read the sms messages (english in canada and kiswahili in tanzania)
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C3178910 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0586740 (UMLS CUI [3,2])
C0038977 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs | Therapeutic procedure Recent
Item
participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Elective Surgical Procedure Planned | Exception Cataract surgery
Item
planned elective surgery during the study period except for cataract surgery
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2939459 (UMLS CUI [2,2])
Absence Antihypertensive Agents Recent
Item
*for bp screening study, must not be on an antihypertensive in the last 6 months.
boolean
C0332197 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
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