ID

17295

Beschreibung

Family Management of Childhood Diabetes Study; ODM derived from: https://clinicaltrials.gov/show/NCT00340938

Link

https://clinicaltrials.gov/show/NCT00340938

Stichworte

Versionen (2)
  1. 05.09.16 05.09.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

5. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT00340938

Englisch

Eligibility Diabetes NCT00340938

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00340938
Criteria
Beschreibung

Criteria

age 9.0 to 14.5
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
type i diabetes diagnosis (diagnosed by ada criteria) for a minimum of 1 year requiring insulin treatment
Beschreibung

Insulin-Dependent Diabetes Mellitus disease length | Insulin regime Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0686904
insulin dose greater than or equal to 0.5 u/kg/day
Beschreibung

Insulin Dose Unit/kilogram/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1532634
mean a1c over last 8 months is less than 13.0%
Beschreibung

Glycosylated hemoglobin A mean Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0439165
no major chronic diseases (except well-controlled thyroid, asthma)
Beschreibung

Chronic disease Major | Thyroid Diseases Well controlled | Asthma Well controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C3853142
UMLS CUI [3,1]
C0004096
UMLS CUI [3,2]
C3853142
no major visual/auditory impairments
Beschreibung

Visual Impairment Major | Auditory impairment Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C3151659
UMLS CUI [2,2]
C0205164
child is not in self-contained special education class throughout the school day
Beschreibung

Child Received childhood special education

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C1827750
no dsm-iv diagnosis of bipolar, addiction, psychosis, or eating disorder documented in existing medical chart. no record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. no history of anti-psychotic medications for the past 6 months.
Beschreibung

Bipolar Disorder | Substance Dependence | Psychotic Disorders | Eating Disorders | Hospitalization Mental disorders | rehabilitation; substance abuse | Eating disorder counseling | Antipsychotic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0013473
UMLS CUI [5,1]
C0019993
UMLS CUI [5,2]
C0004936
UMLS CUI [6]
C1404088
UMLS CUI [7]
C0730425
UMLS CUI [8]
C0040615
no diagnosis of mental retardation.
Beschreibung

Mental Retardation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
literate (reading, writing) in english/spanish at 2nd grade level
Beschreibung

Able to read English Language Grade Level | Able to write English Language Grade Level | Able to read Spanish Language Grade Level | Able to write Spanish Language Grade Level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0870612
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C0870612
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0037750
UMLS CUI [3,3]
C0870612
UMLS CUI [4,1]
C0584993
UMLS CUI [4,2]
C0037750
UMLS CUI [4,3]
C0870612
willing to provide informed assent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
children who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. children cannot enroll in another study during the course of this study. those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. however, children who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
Beschreibung

Study Subject Participation Status | Observational Study | Interventional Study | Behavioral, Psychological or Informational Intervention | Clinical Study Follow-up Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1518527
UMLS CUI [3]
C3274035
UMLS CUI [4]
C1879796
UMLS CUI [5,1]
C3274571
UMLS CUI [5,2]
C0205197
parent/family environment criteria:
Beschreibung

family environment criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680056
UMLS CUI [1,2]
C0243161
child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected to next 2 years.
Beschreibung

Home environment geographical Stable | foster homes multiple | Boarding school

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C0681784
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0599761
UMLS CUI [2,2]
C0439064
UMLS CUI [3]
C0424935
the same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and a single adult, who has primary responsibility for the child's diabetes care and monitoring, agrees to participate in all aspects of the protocol (single-parent families, blended families and separated parents will be eligible).
Beschreibung

Diabetes Clinic Visits | Adult Responsible Agreeing on diabetes care plan | Protocol Compliance | Single-Parent Family | blended family | Parents separated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011847
UMLS CUI [1,2]
C0008952
UMLS CUI [2,1]
C0001675
UMLS CUI [2,2]
C1273518
UMLS CUI [2,3]
C3840174
UMLS CUI [3]
C0525058
UMLS CUI [4]
C0037178
UMLS CUI [5]
C0680029
UMLS CUI [6]
C0425164
family has no plan to re-locate out of area within the next 2 years of the study.
Beschreibung

Family Relocation of home Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C2699029
UMLS CUI [1,3]
C1301732
home has telephone access
Beschreibung

Home Access to telephone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C1822200
primary parent is not currently undergoing treatment for substance abuse.
Beschreibung

Substance Abuse Treatment Parent Primary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2551443
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0205225
primary parent has not been hospitalized in past 6 months for mental disorder.
Beschreibung

Parent Primary | Hospitalization Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0004936
primary caretaker has no history of psychosis.
Beschreibung

Primary caregiver Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1830484
UMLS CUI [1,2]
C0033975
child had at least 2 clinic visits within last 12 months
Beschreibung

Clinic Visits Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C1265611
parent and child wiling to come to clinic every 3 months for duration (2 years) of study.
Beschreibung

Clinic Visits Frequency Child | Clinic Visits Frequency Parent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C0376249
UMLS CUI [1,3]
C0008059
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0376249
UMLS CUI [2,3]
C0030551
families who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. families cannot enroll in another study during the course of this study. those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 month are also ineligible to participate. however, families who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
Beschreibung

Family Study Subject Participation Status | Observational Study | Interventional Study | Behavioral, Psychological or Informational Intervention | Clinical Study Follow-up Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C2348568
UMLS CUI [2]
C1518527
UMLS CUI [3]
C3274035
UMLS CUI [4]
C1879796
UMLS CUI [5,1]
C3274571
UMLS CUI [5,2]
C0205197
if a family has more than one eligible child, all qualifying children who provide consent/assent will participate in assessment and intervention or control activities; however, only the oldest qualifying child will be included in statistical analyses.
Beschreibung

Quantity Child eligible | Informed Consent | Study Subject Participation Status | Statistical analysis Child Age Highest

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C1548635
UMLS CUI [2]
C0021430
UMLS CUI [3]
C2348568
UMLS CUI [4,1]
C0871424
UMLS CUI [4,2]
C0008059
UMLS CUI [4,3]
C0001779
UMLS CUI [4,4]
C1522410
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Ähnliche Modelle

Eligibility Diabetes NCT00340938

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00340938
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
age 9.0 to 14.5
boolean
C0001779 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus disease length | Insulin regime Patient need for
Item
type i diabetes diagnosis (diagnosed by ada criteria) for a minimum of 1 year requiring insulin treatment
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Insulin Dose Unit/kilogram/day
Item
insulin dose greater than or equal to 0.5 u/kg/day
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
Glycosylated hemoglobin A mean Percentage
Item
mean a1c over last 8 months is less than 13.0%
boolean
C0019018 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Chronic disease Major | Thyroid Diseases Well controlled | Asthma Well controlled
Item
no major chronic diseases (except well-controlled thyroid, asthma)
boolean
C0008679 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C3853142 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3,1])
C3853142 (UMLS CUI [3,2])
Visual Impairment Major | Auditory impairment Major
Item
no major visual/auditory impairments
boolean
C3665347 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C3151659 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Child Received childhood special education
Item
child is not in self-contained special education class throughout the school day
boolean
C0008059 (UMLS CUI [1,1])
C1827750 (UMLS CUI [1,2])
Bipolar Disorder | Substance Dependence | Psychotic Disorders | Eating Disorders | Hospitalization Mental disorders | rehabilitation; substance abuse | Eating disorder counseling | Antipsychotic Agents
Item
no dsm-iv diagnosis of bipolar, addiction, psychosis, or eating disorder documented in existing medical chart. no record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. no history of anti-psychotic medications for the past 6 months.
boolean
C0005586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0013473 (UMLS CUI [4])
C0019993 (UMLS CUI [5,1])
C0004936 (UMLS CUI [5,2])
C1404088 (UMLS CUI [6])
C0730425 (UMLS CUI [7])
C0040615 (UMLS CUI [8])
Mental Retardation
Item
no diagnosis of mental retardation.
boolean
C0025362 (UMLS CUI [1])
Able to read English Language Grade Level | Able to write English Language Grade Level | Able to read Spanish Language Grade Level | Able to write Spanish Language Grade Level
Item
literate (reading, writing) in english/spanish at 2nd grade level
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0870612 (UMLS CUI [1,3])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0870612 (UMLS CUI [2,3])
C0586740 (UMLS CUI [3,1])
C0037750 (UMLS CUI [3,2])
C0870612 (UMLS CUI [3,3])
C0584993 (UMLS CUI [4,1])
C0037750 (UMLS CUI [4,2])
C0870612 (UMLS CUI [4,3])
Informed consent
Item
willing to provide informed assent
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Observational Study | Interventional Study | Behavioral, Psychological or Informational Intervention | Clinical Study Follow-up Complete
Item
children who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. children cannot enroll in another study during the course of this study. those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. however, children who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
boolean
C2348568 (UMLS CUI [1])
C1518527 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
C1879796 (UMLS CUI [4])
C3274571 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
family environment criteria
Item
parent/family environment criteria:
boolean
C0680056 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Home environment geographical Stable | foster homes multiple | Boarding school
Item
child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected to next 2 years.
boolean
C0442519 (UMLS CUI [1,1])
C0681784 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0599761 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0424935 (UMLS CUI [3])
Diabetes Clinic Visits | Adult Responsible Agreeing on diabetes care plan | Protocol Compliance | Single-Parent Family | blended family | Parents separated
Item
the same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and a single adult, who has primary responsibility for the child's diabetes care and monitoring, agrees to participate in all aspects of the protocol (single-parent families, blended families and separated parents will be eligible).
boolean
C0011847 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0001675 (UMLS CUI [2,1])
C1273518 (UMLS CUI [2,2])
C3840174 (UMLS CUI [2,3])
C0525058 (UMLS CUI [3])
C0037178 (UMLS CUI [4])
C0680029 (UMLS CUI [5])
C0425164 (UMLS CUI [6])
Family Relocation of home Planned
Item
family has no plan to re-locate out of area within the next 2 years of the study.
boolean
C0015576 (UMLS CUI [1,1])
C2699029 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Home Access to telephone
Item
home has telephone access
boolean
C0442519 (UMLS CUI [1,1])
C1822200 (UMLS CUI [1,2])
Substance Abuse Treatment Parent Primary
Item
primary parent is not currently undergoing treatment for substance abuse.
boolean
C2551443 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Parent Primary | Hospitalization Mental disorders
Item
primary parent has not been hospitalized in past 6 months for mental disorder.
boolean
C0030551 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
Primary caregiver Psychotic Disorders
Item
primary caretaker has no history of psychosis.
boolean
C1830484 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
Clinic Visits Quantity
Item
child had at least 2 clinic visits within last 12 months
boolean
C0008952 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Clinic Visits Frequency Child | Clinic Visits Frequency Parent
Item
parent and child wiling to come to clinic every 3 months for duration (2 years) of study.
boolean
C0008952 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0008059 (UMLS CUI [1,3])
C0008952 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
Family Study Subject Participation Status | Observational Study | Interventional Study | Behavioral, Psychological or Informational Intervention | Clinical Study Follow-up Complete
Item
families who are currently enrolled in any other study (observational or interventional) are not eligible for enrollment. families cannot enroll in another study during the course of this study. those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 month are also ineligible to participate. however, families who were in a standard care control group in an intervention study or who were in an observational study are eligible once they have completed all scheduled study follow-ups.
boolean
C0015576 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1518527 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
C1879796 (UMLS CUI [4])
C3274571 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Quantity Child eligible | Informed Consent | Study Subject Participation Status | Statistical analysis Child Age Highest
Item
if a family has more than one eligible child, all qualifying children who provide consent/assent will participate in assessment and intervention or control activities; however, only the oldest qualifying child will be included in statistical analyses.
boolean
C1265611 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0871424 (UMLS CUI [4,1])
C0008059 (UMLS CUI [4,2])
C0001779 (UMLS CUI [4,3])
C1522410 (UMLS CUI [4,4])
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