ID

13621

Description

Coordinating Center for Enhancing ADRD Caregiving; ODM derived from: https://clinicaltrials.gov/show/NCT00178165

Link

https://clinicaltrials.gov/show/NCT00178165

Keywords

Versions (1)
  1. 2/21/16 2/21/16 -
Uploaded on

February 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Dementia NCT00178165

English

Eligibility Dementia NCT00178165

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00178165
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. nincds -adrda criteria for alzheimer’s disease and/or dsm iv criteria for alzheimer’s disease or other dementia or mmse score < 23.
Description

Alzheimer disease, mmse

Data type

boolean

Alias
UMLS CUI [1]
C2828081
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0451306
2. functional impairment: presence of two iadl or one adl impairments.
Description

impairment, iadl adl impairments

Data type

boolean

Alias
UMLS CUI [1]
C0150641
UMLS CUI [2]
C0001288
UMLS CUI [3]
C0221099
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any terminal illness with life expectancy < 6 months
Description

life expectancy, comorbiditiy

Data type

text

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0009488
2. active treatment (chemotherapy, radiation therapy) for cancer
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
3. more than three acute medical hospitalizations in past year (not for psychiatric or alzheimer’s disease related admission)
Description

hospitalizations in past year

Data type

boolean

Alias
UMLS CUI [1]
C0019993
4. schizophrenia (onset of delusions before age 45)
Description

schizophrenia

Data type

boolean

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

dementia secondary to head trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0018674
6. blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
Description

blindness or deafness limiting compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
7. 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, bedbound

Data type

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2]
C0425251
8. planned nursing home admission in 6 months
Description

planned nursing home admission

Data type

boolean

Alias
UMLS CUI [1,1]
C0028688
UMLS CUI [1,2]
C1301732
Inclusion Criteria for core caregiver
Description

Inclusion Criteria for core caregiver

Alias
UMLS CUI-1
C1512693
1. age: 21 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. language: site specific, must be competent either orally or written
Description

language

Data type

boolean

Alias
UMLS CUI [1]
C1145677
3. lives with care recipient
Description

living situation

Data type

boolean

Alias
UMLS CUI [1]
C2184149
4. family member
Description

family member

Data type

boolean

Alias
UMLS CUI [1]
C0086282
5. gender: palo alto/los angeles will only enroll women. all other sites will enroll men and women
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
6. must have a telephone
Description

telephone

Data type

boolean

Alias
UMLS CUI [1]
C1321605
7. at enrollment, plan to remain in area for the duration of the intervention and follow-up
Description

remain in area for the duration of the intervention and follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1321605
8. caregiver role of at least 6 months
Description

Caregiver role duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C0449238
9. provides > 4 hours of supervision or direct assistance per day for the care recipient
Description

supervision or direct assistance time per day

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria for core caregiver
Description

Exclusion Criteria for core caregiver

Alias
UMLS CUI-1
C0680251
1. any terminal illness with life expectancy < 6 months
Description

life expectancy, comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0009488
2. active treatment (chemotherapy, radiation therapy) for cancer
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
3. more than three acute medical hospitalizations in past year
Description

hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
4. involved in another clinical trial of interventions for caregivers (non drug study)
Description

Study participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
second level review if the caregiver has been inconsistent with answers or repeated answers, then the interviewer will administer the spmsq. the interviewer will then discuss with the pi and coordinate another phone call with the caregiver.
Description

second level review

Data type

boolean

Alias
UMLS CUI [1]
C1321605
if in the course of the telephone screen the research assistant believes that there may be difficulties for the caregiver regarding travel arrangements, hesitancy to answer questions, or other specific items (site-specific indications), the research assistant will refer to the pi for review.
Description

difficulties for the caregiver

Data type

boolean

Alias
UMLS CUI [1]
C1321605
all potential caregivers will receive a follow-up phone call for second level exclusion from the trial when appropriate.
Description

follow-up phone call for second level exclusion for caregivers

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Dementia NCT00178165

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Dementia NCT00178165
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Alzheimer disease, mmse
Item
1. nincds -adrda criteria for alzheimer’s disease and/or dsm iv criteria for alzheimer’s disease or other dementia or mmse score < 23.
boolean
C2828081 (UMLS CUI [1])
C0002395 (UMLS CUI [2])
C0451306 (UMLS CUI [3])
impairment, iadl adl impairments
Item
2. functional impairment: presence of two iadl or one adl impairments.
boolean
C0150641 (UMLS CUI [1])
C0001288 (UMLS CUI [2])
C0221099 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
life expectancy, comorbiditiy
Item
1. any terminal illness with life expectancy < 6 months
text
C0023671 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
cancer treatment
Item
2. active treatment (chemotherapy, radiation therapy) for cancer
boolean
C0920425 (UMLS CUI [1])
hospitalizations in past year
Item
3. more than three acute medical hospitalizations in past year (not for psychiatric or alzheimer’s disease related admission)
boolean
C0019993 (UMLS CUI [1])
schizophrenia
Item
4. schizophrenia (onset of delusions before age 45)
boolean
C0036341 (UMLS CUI [1])
dementia secondary to head trauma
Item
5. dementia secondary to head trauma (probable)
boolean
C0497327 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0018674 (UMLS CUI [1,3])
blindness or deafness limiting compliance
Item
6. blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
boolean
C1321605 (UMLS CUI [1])
mmse, bedbound
Item
7. 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
C0451306 (UMLS CUI [1])
C0425251 (UMLS CUI [2])
planned nursing home admission
Item
8. planned nursing home admission in 6 months
boolean
C0028688 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Item Group
Inclusion Criteria for core caregiver
C1512693 (UMLS CUI-1)
Age
Item
1. age: 21 years and older
boolean
C0001779 (UMLS CUI [1])
language
Item
2. language: site specific, must be competent either orally or written
boolean
C1145677 (UMLS CUI [1])
living situation
Item
3. lives with care recipient
boolean
C2184149 (UMLS CUI [1])
family member
Item
4. family member
boolean
C0086282 (UMLS CUI [1])
Gender
Item
5. gender: palo alto/los angeles will only enroll women. all other sites will enroll men and women
boolean
C0079399 (UMLS CUI [1])
telephone
Item
6. must have a telephone
boolean
C1321605 (UMLS CUI [1])
remain in area for the duration of the intervention and follow-up
Item
7. at enrollment, plan to remain in area for the duration of the intervention and follow-up
boolean
C1321605 (UMLS CUI [1])
Caregiver role duration
Item
8. caregiver role of at least 6 months
boolean
C0085537 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
supervision or direct assistance time per day
Item
9. provides > 4 hours of supervision or direct assistance per day for the care recipient
boolean
C1321605 (UMLS CUI [1])
Item Group
Exclusion Criteria for core caregiver
C0680251 (UMLS CUI-1)
life expectancy, comorbidity
Item
1. any terminal illness with life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
cancer treatment
Item
2. active treatment (chemotherapy, radiation therapy) for cancer
boolean
C0920425 (UMLS CUI [1])
hospitalization
Item
3. more than three acute medical hospitalizations in past year
boolean
C0019993 (UMLS CUI [1])
Study participation status
Item
4. involved in another clinical trial of interventions for caregivers (non drug study)
boolean
C2348568 (UMLS CUI [1])
second level review
Item
second level review if the caregiver has been inconsistent with answers or repeated answers, then the interviewer will administer the spmsq. the interviewer will then discuss with the pi and coordinate another phone call with the caregiver.
boolean
C1321605 (UMLS CUI [1])
difficulties for the caregiver
Item
if in the course of the telephone screen the research assistant believes that there may be difficulties for the caregiver regarding travel arrangements, hesitancy to answer questions, or other specific items (site-specific indications), the research assistant will refer to the pi for review.
boolean
C1321605 (UMLS CUI [1])
follow-up phone call for second level exclusion for caregivers
Item
all potential caregivers will receive a follow-up phone call for second level exclusion from the trial when appropriate.
boolean
C1321605 (UMLS CUI [1])
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