ID

18829

Beskrivning

Electronic Compliance Monitoring in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00361205

Länk

https://clinicaltrials.gov/show/NCT00361205

Nyckelord

Versioner (1)
  1. 2016-11-21 2016-11-21 -
Uppladdad den

21 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00361205

Engelsk

Eligibility Parkinson's Disease NCT00361205

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women between 18 and 80 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient has idiopathic parkinson's disease according to brain bank criteria. reference hughes a j, daniel s e, kilford l, lees a j, accuracy of clinical diagnosis of idiopathic parkinson's disease; a clinical pathological study of 100 cases, jnnp 1992, 55(3): 181 - 184
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
patient is on stable doses of anti-parkinson's disease medication, which are not expected to change during the study period.
Beskrivning

Antiparkinson Agents Dose Stable unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0442739
patient is taking levodopa and/or dopamine agonist treatment.
Beskrivning

Levodopa | Dopamine Agonists

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0178601
patient (assisted by a carer where appropriate) is able to take their medication using the mems (electronic monitoring) containers.
Beskrivning

Intake Pharmaceutical Preparations Electronic monitor Container Use of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0336646
UMLS CUI [1,4]
C0180098
UMLS CUI [1,5]
C1524063
patients using a dosette box or similar device for their medication are willing to use the mems containers for their pd medication
Beskrivning

Dosette Use of | Antiparkinson Agents Electronic monitor Container Use of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1553470
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0336646
UMLS CUI [2,3]
C0180098
UMLS CUI [2,4]
C1524063
the investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the mems device.
Beskrivning

Study Subject Participation Status Affecting patient care | Study Subject Participation Status Affecting Symptom control | Electronic monitor Container Use Affecting patient care | Electronic monitor Container Use Affecting Symptom control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017313
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1274136
UMLS CUI [3,1]
C0336646
UMLS CUI [3,2]
C0180098
UMLS CUI [3,3]
C1524063
UMLS CUI [3,4]
C0392760
UMLS CUI [3,5]
C0017313
UMLS CUI [4,1]
C0336646
UMLS CUI [4,2]
C0180098
UMLS CUI [4,3]
C1524063
UMLS CUI [4,4]
C0392760
UMLS CUI [4,5]
C1274136
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is taking anti-parkinson’s disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). intermittent domperidone is allowed.
Beskrivning

Antiparkinson Agents Intermittent | Antiparkinson Agents As required | Emergency treatment | Domperidone Intermittent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205267
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0558288
UMLS CUI [3]
C0013969
UMLS CUI [4,1]
C0013015
UMLS CUI [4,2]
C0205267
severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the parkinson’s disease in terms of life expectancy and levels of care required.
Beskrivning

Comorbidity Severe | Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Malignant Neoplasms | Parkinson Disease | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0006826
UMLS CUI [6]
C0030567
UMLS CUI [7]
C0023671
patient is expected to undergo hospital admission during the study period (such as elective surgery).
Beskrivning

Hospital admission Expected | Elective Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C1517001
UMLS CUI [2]
C0206058
patient is on non standard drug treatment / combination therapy. this would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
Beskrivning

Standard of Care | Combined Modality Therapy | Dopamine Agonists Oral Different Quantity | Dopamine Agonists High dose Very

Datatyp

boolean

Alias
UMLS CUI [1]
C2936643
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0178601
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1705242
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C0178601
UMLS CUI [4,2]
C0444956
UMLS CUI [4,3]
C0442824
new antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
Beskrivning

Antiparkinson Agents new therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C3242274
patient is taking only adjunct therapy (eg. selegiline, amantadine, anticholinergic therapy).
Beskrivning

Adjuvant therapy | Selegiline | Amantadine | Anticholinergic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C0036579
UMLS CUI [3]
C0002403
UMLS CUI [4]
C0242896
patient is taking part in a clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Parkinson's Disease NCT00361205

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women between 18 and 80 years.
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease
Item
patient has idiopathic parkinson's disease according to brain bank criteria. reference hughes a j, daniel s e, kilford l, lees a j, accuracy of clinical diagnosis of idiopathic parkinson's disease; a clinical pathological study of 100 cases, jnnp 1992, 55(3): 181 - 184
boolean
C0030567 (UMLS CUI [1])
Antiparkinson Agents Dose Stable unchanged
Item
patient is on stable doses of anti-parkinson's disease medication, which are not expected to change during the study period.
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0442739 (UMLS CUI [1,4])
Levodopa | Dopamine Agonists
Item
patient is taking levodopa and/or dopamine agonist treatment.
boolean
C0023570 (UMLS CUI [1])
C0178601 (UMLS CUI [2])
Intake Pharmaceutical Preparations Electronic monitor Container Use of
Item
patient (assisted by a carer where appropriate) is able to take their medication using the mems (electronic monitoring) containers.
boolean
C1512806 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0336646 (UMLS CUI [1,3])
C0180098 (UMLS CUI [1,4])
C1524063 (UMLS CUI [1,5])
Dosette Use of | Antiparkinson Agents Electronic monitor Container Use of
Item
patients using a dosette box or similar device for their medication are willing to use the mems containers for their pd medication
boolean
C1553470 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0336646 (UMLS CUI [2,2])
C0180098 (UMLS CUI [2,3])
C1524063 (UMLS CUI [2,4])
Study Subject Participation Status Affecting patient care | Study Subject Participation Status Affecting Symptom control | Electronic monitor Container Use Affecting patient care | Electronic monitor Container Use Affecting Symptom control
Item
the investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the mems device.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017313 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1274136 (UMLS CUI [2,3])
C0336646 (UMLS CUI [3,1])
C0180098 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
C0392760 (UMLS CUI [3,4])
C0017313 (UMLS CUI [3,5])
C0336646 (UMLS CUI [4,1])
C0180098 (UMLS CUI [4,2])
C1524063 (UMLS CUI [4,3])
C0392760 (UMLS CUI [4,4])
C1274136 (UMLS CUI [4,5])
Item Group
C0680251 (UMLS CUI)
Antiparkinson Agents Intermittent | Antiparkinson Agents As required | Emergency treatment | Domperidone Intermittent
Item
patient is taking anti-parkinson’s disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). intermittent domperidone is allowed.
boolean
C0003405 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0558288 (UMLS CUI [2,2])
C0013969 (UMLS CUI [3])
C0013015 (UMLS CUI [4,1])
C0205267 (UMLS CUI [4,2])
Comorbidity Severe | Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Malignant Neoplasms | Parkinson Disease | Life Expectancy
Item
severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the parkinson’s disease in terms of life expectancy and levels of care required.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5])
C0030567 (UMLS CUI [6])
C0023671 (UMLS CUI [7])
Hospital admission Expected | Elective Surgical Procedures
Item
patient is expected to undergo hospital admission during the study period (such as elective surgery).
boolean
C0184666 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2])
Standard of Care | Combined Modality Therapy | Dopamine Agonists Oral Different Quantity | Dopamine Agonists High dose Very
Item
patient is on non standard drug treatment / combination therapy. this would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
boolean
C2936643 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0178601 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0178601 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C0442824 (UMLS CUI [4,3])
Antiparkinson Agents new therapy
Item
new antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
boolean
C0003405 (UMLS CUI [1,1])
C3242274 (UMLS CUI [1,2])
Adjuvant therapy | Selegiline | Amantadine | Anticholinergic Agents
Item
patient is taking only adjunct therapy (eg. selegiline, amantadine, anticholinergic therapy).
boolean
C0677850 (UMLS CUI [1])
C0036579 (UMLS CUI [2])
C0002403 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
Study Subject Participation Status
Item
patient is taking part in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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