ID

39524

Beschreibung

REmoTe TelenURsiNg on Lung Function of Heart Failure Outpatients; ODM derived from: https://clinicaltrials.gov/show/NCT02387190

Link

https://clinicaltrials.gov/show/NCT02387190

Stichworte

Versionen (1)
  1. 23.01.20 23.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Januar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT02387190

Englisch

Eligibility Heart Failure NCT02387190

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. with prior medical diagnosis of heart failure with functional class i, ii or iii, in accordance to new york heart association (nyra)8.
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
2. in regular follow-up for at least six months at the study site. regular follow will be considered when in the period of six months the individual attend at least 2/3 of the scheduled appointments of outpatient unit and 100% of run-in period appointments.
Beschreibung

Follow-up Regular | Appointments Outpatient facility | Appointments Run-in Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0003629
UMLS CUI [2,2]
C1550683
UMLS CUI [3,1]
C0003629
UMLS CUI [3,2]
C3274438
3. with dyspnoea or spirometric volumes evidencing deterioration of lung function.
Beschreibung

Dyspnea | Deterioration of lung function Spirometry

Datentyp

boolean

Alias
UMLS CUI [1]
C0013404
UMLS CUI [2,1]
C4014536
UMLS CUI [2,2]
C0037981
4. with cognitive conditions to be interviewed.
Beschreibung

Cognition:status Patient interview

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0945985
UMLS CUI [1,2]
C0683518
5. with no medical restrictions to perform spirometry testing and six-minute walk test.
Beschreibung

Absence Restriction Medical | Spirometry test | 6-Minute Walk Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C0205476
UMLS CUI [2]
C0037981
UMLS CUI [3]
C0430515
6. with clinical control of the heart failure.
Beschreibung

Control Clinical Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2587213
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. with psychiatric disorders;
Beschreibung

Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
2. who do not meet eligibility criteria after run-in period;
Beschreibung

Eligibility Criteria failed | Status post Run-in Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3274438
3. with severe acute or chronic pulmonary disease;
Beschreibung

Lung disease Severe | Chronic lung disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0746102
4. who change clinical parameters during the data collection (severe dyspnoea, peripherical oxygen saturation below 95%).
Beschreibung

Parameters Clinical Changed | Dyspnea Severe | Peripheral oxygen saturation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0013404
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2317096
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Ähnliche Modelle

Eligibility Heart Failure NCT02387190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
1. with prior medical diagnosis of heart failure with functional class i, ii or iii, in accordance to new york heart association (nyra)8.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Follow-up Regular | Appointments Outpatient facility | Appointments Run-in Period
Item
2. in regular follow-up for at least six months at the study site. regular follow will be considered when in the period of six months the individual attend at least 2/3 of the scheduled appointments of outpatient unit and 100% of run-in period appointments.
boolean
C3274571 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0003629 (UMLS CUI [2,1])
C1550683 (UMLS CUI [2,2])
C0003629 (UMLS CUI [3,1])
C3274438 (UMLS CUI [3,2])
Dyspnea | Deterioration of lung function Spirometry
Item
3. with dyspnoea or spirometric volumes evidencing deterioration of lung function.
boolean
C0013404 (UMLS CUI [1])
C4014536 (UMLS CUI [2,1])
C0037981 (UMLS CUI [2,2])
Cognition:status Patient interview
Item
4. with cognitive conditions to be interviewed.
boolean
C0945985 (UMLS CUI [1,1])
C0683518 (UMLS CUI [1,2])
Absence Restriction Medical | Spirometry test | 6-Minute Walk Test
Item
5. with no medical restrictions to perform spirometry testing and six-minute walk test.
boolean
C0332197 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0205476 (UMLS CUI [1,3])
C0037981 (UMLS CUI [2])
C0430515 (UMLS CUI [3])
Control Clinical Heart failure
Item
6. with clinical control of the heart failure.
boolean
C2587213 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Mental disorders
Item
1. with psychiatric disorders;
boolean
C0004936 (UMLS CUI [1])
Eligibility Criteria failed | Status post Run-in Period
Item
2. who do not meet eligibility criteria after run-in period;
boolean
C1516637 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C3274438 (UMLS CUI [2,2])
Lung disease Severe | Chronic lung disease
Item
3. with severe acute or chronic pulmonary disease;
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0746102 (UMLS CUI [2])
Parameters Clinical Changed | Dyspnea Severe | Peripheral oxygen saturation
Item
4. who change clinical parameters during the data collection (severe dyspnoea, peripherical oxygen saturation below 95%).
boolean
C0449381 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013404 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2317096 (UMLS CUI [3])
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