ID

16067

Description

Coordinating Center for Caregiver Intervention Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00177489

Link

https://clinicaltrials.gov/show/NCT00177489

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Dementia NCT00177489

English

Eligibility Dementia NCT00177489

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00177489
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria:
Description

inclusion criteria:

Data type

boolean

Alias
UMLS CUI [1]
C1512693
1. age: 21 years or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. family member of the care recipient
Description

family member of the care recipient

Data type

boolean

Alias
UMLS CUI [1]
C0086282
3. must live with care recipient or share cooking facilities
Description

family member housing with care recipient

Data type

boolean

4. must have a telephone that will enable use of ctis (computer telephone integration system) system
Description

telephone capable of ctis use

Data type

boolean

Alias
UMLS CUI [1]
C0039457
5. must plan to remain in the recruitment area for the duration of the intervention and follow-up
Description

family member remaining in recruitment area

Data type

boolean

6. caregiver role for more than 6 months
Description

caregiver role

Data type

boolean

Alias
UMLS CUI [1]
C0086279
7. must provide on average 4 hours of supervision or direct assistance per day for the care recipient
Description

average assistance time per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0516955
UMLS CUI [1,2]
C0449238
8. risk screening tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9
Description

risk screening score

Data type

boolean

Alias
UMLS CUI [1]
C0449820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-english, non-spanish speaking
Description

english or spanish language skills

Data type

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0037750
2. active treatment (chemotherapy, radiation therapy) for cancer
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
3. imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
Description

living in nursing home/assisted living facility

Data type

boolean

Alias
UMLS CUI [1]
C3841564
4. involvement in another clinical trial for caregivers
Description

clinical trial participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
5. participant in reach i study
Description

participant in reach

Data type

boolean

6. spmsq:> or = 4 errors*
Description

Short Portable Mental Status Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C0451291
if the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the short portable mental status questionnaire (spmsq). if the caregiver missed 4 or more questions, he/she was excluded from the study.
Description

exclusion through spmsq

Data type

boolean

Alias
UMLS CUI [1,1]
C0451291
UMLS CUI [1,2]
C2828389
care recipient inclusion/exclusion criteria
Description

care recipient inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0680251
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a. nincds (md diagnosis) of dementia or cognitive impairment (raw score on mmse of 23 or less)
Description

nincds or mmse score

Data type

boolean

Alias
UMLS CUI [1]
C2828081
UMLS CUI [2]
C1532985
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-english, non-spanish speaking
Description

non-english, non-spanish speaking

Data type

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0037750
2. history of parkinson’s disease or a stroke with no reported decline in memory over the past year
Description

history of parkinson or stroke

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0038454
3. active treatment (chemotherapy, radiation therapy) for cancer
Description

active cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
4. more than three acute medical hospitalizations in past year (other than psychiatric or alzheimer’s disease related admission)
Description

non psychiatric or alzheimer related hospitalizations

Data type

boolean

Alias
UMLS CUI [1]
C0019993
5. schizophrenia (onset of delusions before age 45) or other severe mental illness
Description

schizophrenia or severe mental illness

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0004936
6. dementia secondary to head trauma (probable)
Description

secondary dementia

Data type

boolean

Alias
UMLS CUI [1]
C0856416
7. blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
Description

blindness or deafness prohibiting clinical trial participation

Data type

boolean

Alias
UMLS CUI [1]
C0456909
UMLS CUI [2,1]
C0011053
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0009488
8. mmse = 0 and bedbound (confined to a bed or chair for  22 hours per day, for at least 4 of the past 7 days)
Description

mmse and bedbound

Data type

boolean

Alias
UMLS CUI [1,1]
C1532985
UMLS CUI [1,2]
C0425251
9. planned nursing home admission in 6 months
Description

planned nursing home admission

Data type

boolean

Alias
UMLS CUI [1]
C1658399
10. participant in reach i study
Description

participant in reach i study

Data type

boolean

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Similar models

Eligibility Dementia NCT00177489

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00177489
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
inclusion criteria:
Item
inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
age
Item
1. age: 21 years or older
boolean
C0001779 (UMLS CUI [1])
family member of the care recipient
Item
2. family member of the care recipient
boolean
C0086282 (UMLS CUI [1])
family member housing with care recipient
Item
3. must live with care recipient or share cooking facilities
boolean
telephone capable of ctis use
Item
4. must have a telephone that will enable use of ctis (computer telephone integration system) system
boolean
C0039457 (UMLS CUI [1])
family member remaining in recruitment area
Item
5. must plan to remain in the recruitment area for the duration of the intervention and follow-up
boolean
caregiver role
Item
6. caregiver role for more than 6 months
boolean
C0086279 (UMLS CUI [1])
average assistance time per day
Item
7. must provide on average 4 hours of supervision or direct assistance per day for the care recipient
boolean
C0516955 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
risk screening score
Item
8. risk screening tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9
boolean
C0449820 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
english or spanish language skills
Item
1. non-english, non-spanish speaking
boolean
C0376245 (UMLS CUI [1,1])
C0037750 (UMLS CUI [1,2])
cancer treatment
Item
2. active treatment (chemotherapy, radiation therapy) for cancer
boolean
C0920425 (UMLS CUI [1])
living in nursing home/assisted living facility
Item
3. imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
boolean
C3841564 (UMLS CUI [1])
clinical trial participation status
Item
4. involvement in another clinical trial for caregivers
boolean
C2348568 (UMLS CUI [1])
participant in reach
Item
5. participant in reach i study
boolean
Short Portable Mental Status Questionnaire
Item
6. spmsq:> or = 4 errors*
boolean
C0451291 (UMLS CUI [1])
exclusion through spmsq
Item
if the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the short portable mental status questionnaire (spmsq). if the caregiver missed 4 or more questions, he/she was excluded from the study.
boolean
C0451291 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
care recipient inclusion/exclusion criteria
Item
care recipient inclusion/exclusion criteria
boolean
C0030705 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,3])
Item Group
C1512693 (UMLS CUI)
nincds or mmse score
Item
a. nincds (md diagnosis) of dementia or cognitive impairment (raw score on mmse of 23 or less)
boolean
C2828081 (UMLS CUI [1])
C1532985 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
non-english, non-spanish speaking
Item
1. non-english, non-spanish speaking
boolean
C0376245 (UMLS CUI [1,1])
C0037750 (UMLS CUI [1,2])
history of parkinson or stroke
Item
2. history of parkinson’s disease or a stroke with no reported decline in memory over the past year
boolean
C0262926 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
active cancer treatment
Item
3. active treatment (chemotherapy, radiation therapy) for cancer
boolean
C0920425 (UMLS CUI [1])
non psychiatric or alzheimer related hospitalizations
Item
4. more than three acute medical hospitalizations in past year (other than psychiatric or alzheimer’s disease related admission)
boolean
C0019993 (UMLS CUI [1])
schizophrenia or severe mental illness
Item
5. schizophrenia (onset of delusions before age 45) or other severe mental illness
boolean
C0036341 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
secondary dementia
Item
6. dementia secondary to head trauma (probable)
boolean
C0856416 (UMLS CUI [1])
blindness or deafness prohibiting clinical trial participation
Item
7. blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
boolean
C0456909 (UMLS CUI [1])
C0011053 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
mmse and bedbound
Item
8. mmse = 0 and bedbound (confined to a bed or chair for  22 hours per day, for at least 4 of the past 7 days)
boolean
C1532985 (UMLS CUI [1,1])
C0425251 (UMLS CUI [1,2])
planned nursing home admission
Item
9. planned nursing home admission in 6 months
boolean
C1658399 (UMLS CUI [1])
participant in reach i study
Item
10. participant in reach i study
boolean
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