ID

40865

Beschrijving

ETIC (Therapeutic Education in Heart Failure); ODM derived from: https://clinicaltrials.gov/show/NCT01065142

Link

https://clinicaltrials.gov/show/NCT01065142

Trefwoorden

Versies (1)
  1. 27-05-20 27-05-20 -
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See clinicaltrials.gov

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27 mei 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT01065142

Engels

Eligibility Heart Failure NCT01065142

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
investigators: volunteer randomized general practitioners from the auvergne region in france.
Beschrijving

Research Personnel General Practitioners Randomized

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0017319
UMLS CUI [1,3]
C0034656
the gps will be randomized in cluster, each gp should recruit at least five patients. if several doctors are part of the same surgery, they will be randomized in the same group (intervention or control). the randomization of the gps will be stratified by department. the gp commit themselves not to talk of the study between them. each gp knows in which group of the study he belongs as the intervention group comprises a training seminar but the objectives of the study will not be known by the gps of the control group.
Beschrijving

General Practitioners Randomization | Recruitment Patients Quantity | Intervention Group | Control Groups

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C0034656
UMLS CUI [2,1]
C0242800
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C2986530
UMLS CUI [4]
C0009932
all the general practitioners in auvergne (except homeopaths, acupunctures...) will be contacted by mail to inform them about the study and to invite them to participate to it. the volunteer gps will have to return their written agreement via a pre-stamped envelope to the investigator center with their coordinates. they will be randomized in both groups (intervention and control). after the formation, each gp of the intervention group would have to recruit at least five patients seen in consultation, who could be included and who have given their written agreement. each week of the inclusion period, the gp will recruit the first patient having the eligibility criteria until the inclusion of at least five patients. the anonymity of the patients will be guaranteed in the participation contract. the data will be anonymized by the investigator gp and will be submitted to the french electronic data liberty commission (commission nationale informatique et libertés (cnil)). the patients could quit the study at any time.
Beschrijving

General Practitioners Agreement | Patients Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C0680240
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0021430
patients: systolic or diastolic hf patients to the stages i, ii and iii of the nyha followed in primary care. these patients will be recruited by the randomized gp in the intervention and control groups. patients should be over 50 years old (this age limit expelled only few patients with particular pathology).
Beschrijving

Systolic Heart Failure New York Heart Association Classification | Diastolic Heart Failure New York Heart Association Classification | Patients Primary Care

Datatype

boolean

Alias
UMLS CUI [1,1]
C1135191
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C1135196
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0033137
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
• are not included the stage iv, with short life expectancy, with low efficiency hope of the tested measure, who are very few. the systolic and diastolic hf patients are not distinguished because the possible efficiency of the intervention is not hf type dependent a priori.
Beschrijving

Heart failure New York Heart Association Classification | Life Expectancy Short

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C1806781
dementia as alzheimer disease diagnosed by gp.
Beschrijving

Dementia | Alzheimer's Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0002395
already included in another study
Beschrijving

Study Subject Participation Status | Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
incapacity to follow the education sessions (language problem...)
Beschrijving

Adherence Lacking Patient education | Language problems

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0030688
UMLS CUI [2]
C1405458
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Similar models

Eligibility Heart Failure NCT01065142

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Research Personnel General Practitioners Randomized
Item
investigators: volunteer randomized general practitioners from the auvergne region in france.
boolean
C0035173 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
General Practitioners Randomization | Recruitment Patients Quantity | Intervention Group | Control Groups
Item
the gps will be randomized in cluster, each gp should recruit at least five patients. if several doctors are part of the same surgery, they will be randomized in the same group (intervention or control). the randomization of the gps will be stratified by department. the gp commit themselves not to talk of the study between them. each gp knows in which group of the study he belongs as the intervention group comprises a training seminar but the objectives of the study will not be known by the gps of the control group.
boolean
C0017319 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0242800 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2986530 (UMLS CUI [3])
C0009932 (UMLS CUI [4])
General Practitioners Agreement | Patients Informed Consent
Item
all the general practitioners in auvergne (except homeopaths, acupunctures...) will be contacted by mail to inform them about the study and to invite them to participate to it. the volunteer gps will have to return their written agreement via a pre-stamped envelope to the investigator center with their coordinates. they will be randomized in both groups (intervention and control). after the formation, each gp of the intervention group would have to recruit at least five patients seen in consultation, who could be included and who have given their written agreement. each week of the inclusion period, the gp will recruit the first patient having the eligibility criteria until the inclusion of at least five patients. the anonymity of the patients will be guaranteed in the participation contract. the data will be anonymized by the investigator gp and will be submitted to the french electronic data liberty commission (commission nationale informatique et libertés (cnil)). the patients could quit the study at any time.
boolean
C0017319 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Systolic Heart Failure New York Heart Association Classification | Diastolic Heart Failure New York Heart Association Classification | Patients Primary Care
Item
patients: systolic or diastolic hf patients to the stages i, ii and iii of the nyha followed in primary care. these patients will be recruited by the randomized gp in the intervention and control groups. patients should be over 50 years old (this age limit expelled only few patients with particular pathology).
boolean
C1135191 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1135196 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0033137 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Heart failure New York Heart Association Classification | Life Expectancy Short
Item
• are not included the stage iv, with short life expectancy, with low efficiency hope of the tested measure, who are very few. the systolic and diastolic hf patients are not distinguished because the possible efficiency of the intervention is not hf type dependent a priori.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C1806781 (UMLS CUI [2,2])
Dementia | Alzheimer's Disease
Item
dementia as alzheimer disease diagnosed by gp.
boolean
C0497327 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
already included in another study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Adherence Lacking Patient education | Language problems
Item
incapacity to follow the education sessions (language problem...)
boolean
C1510802 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0030688 (UMLS CUI [1,3])
C1405458 (UMLS CUI [2])
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