ID

32091

Beskrivning

Study With Information Technology (IT) - Aided Preventive Program in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00712660

Länk

https://clinicaltrials.gov/show/NCT00712660

Nyckelord

Versioner (2)
  1. 2018-10-17 2018-10-17 -
  2. 2018-10-17 2018-10-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00712660

Engelsk

Eligibility Schizophrenia NCT00712660

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women, ages 18 to 60 years, inclusive. earliest inclusion day is the 18th birthday and the latest is the day before the 61st birthday.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. a diagnosis of schizophrenia or schizoaffective disorder according to icd-10 classification.
Beskrivning

Schizophrenia | Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
3. increased risk for relapse, defined as having at least 1 psychiatric hospitalization for psychosis within the past 3 years and at least 2 psychiatric hospitalizations for psychosis in total (i.e. ≥ 2 hospitalizations).
Beskrivning

At risk for relapse | Hospitalization Quantity Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C1320679
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0033975
4. clinical global impression scale - severity (cgi-s) ≤ 3 at study visit 1.
Beskrivning

Clinical global impression scale

Datatyp

boolean

Alias
UMLS CUI [1]
C3639708
5. all patients must be on stable doses of antipsychotic medication during the study entry.
Beskrivning

Antipsychotic Agents Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
6. absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
Beskrivning

Organic mental disorder Absent | Absence Mental disorder Due to Psychoactive substance | Absence Mental disorder Due to Mental Retardation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0029227
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0004936
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0682880
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0004936
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0025362
7. presence of a cooperating family member, caregiver or other person who is in frequent contact with the patient (at least 4 times a week) and who is willing to participate in the trial.
Beskrivning

Presence Family member cooperative | Presence Caregiver

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150312
UMLS CUI [1,2]
C0086282
UMLS CUI [1,3]
C0679729
UMLS CUI [2,1]
C0150312
UMLS CUI [2,2]
C0085537
8. signed written informed consent. the informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
9. eligibility for mobile phone communicating.
Beskrivning

Mobile Phone Communication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1136360
UMLS CUI [1,2]
C0009452
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participation in another relapse prevention program or another interventional clinical trial will be prohibited during the entire participation in the study. subjects enrolled in observational (non-interventional) trials are not excluded from this study.
Beskrivning

Study Subject Participation Status | Relapse Prevention | Interventional procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0679867
UMLS CUI [3]
C0184661
2. hayward compliance rating scale score < 2 at visit 1.
Beskrivning

Compliance behavior Rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0681889
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Similar models

Eligibility Schizophrenia NCT00712660

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men and women, ages 18 to 60 years, inclusive. earliest inclusion day is the 18th birthday and the latest is the day before the 61st birthday.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder
Item
2. a diagnosis of schizophrenia or schizoaffective disorder according to icd-10 classification.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
At risk for relapse | Hospitalization Quantity Psychotic Disorders
Item
3. increased risk for relapse, defined as having at least 1 psychiatric hospitalization for psychosis within the past 3 years and at least 2 psychiatric hospitalizations for psychosis in total (i.e. ≥ 2 hospitalizations).
boolean
C1320679 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0033975 (UMLS CUI [2,3])
Clinical global impression scale
Item
4. clinical global impression scale - severity (cgi-s) ≤ 3 at study visit 1.
boolean
C3639708 (UMLS CUI [1])
Antipsychotic Agents Dose Stable
Item
5. all patients must be on stable doses of antipsychotic medication during the study entry.
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Organic mental disorder Absent | Absence Mental disorder Due to Psychoactive substance | Absence Mental disorder Due to Mental Retardation
Item
6. absence of organic mental disorder, mental disorder due to psychoactive substance use or mental retardation.
boolean
C0029227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0682880 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0004936 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0025362 (UMLS CUI [3,4])
Presence Family member cooperative | Presence Caregiver
Item
7. presence of a cooperating family member, caregiver or other person who is in frequent contact with the patient (at least 4 times a week) and who is willing to participate in the trial.
boolean
C0150312 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0679729 (UMLS CUI [1,3])
C0150312 (UMLS CUI [2,1])
C0085537 (UMLS CUI [2,2])
Informed Consent
Item
8. signed written informed consent. the informed consent process must be documented by signing the informed consent form prior to any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
Mobile Phone Communication
Item
9. eligibility for mobile phone communicating.
boolean
C1136360 (UMLS CUI [1,1])
C0009452 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Relapse Prevention | Interventional procedure
Item
1. participation in another relapse prevention program or another interventional clinical trial will be prohibited during the entire participation in the study. subjects enrolled in observational (non-interventional) trials are not excluded from this study.
boolean
C2348568 (UMLS CUI [1])
C0679867 (UMLS CUI [2])
C0184661 (UMLS CUI [3])
Compliance behavior Rating scale
Item
2. hayward compliance rating scale score < 2 at visit 1.
boolean
C1321605 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
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