ID

29937

Description

Medication Adherence in Hypertension Study; ODM derived from: https://clinicaltrials.gov/show/NCT00688350

Link

https://clinicaltrials.gov/show/NCT00688350

Keywords

Versions (2)
  1. 4/27/18 4/27/18 -
  2. 4/27/18 4/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00688350

English

Eligibility Hypertension NCT00688350

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants will be aged 60 years or greater at time of study entry.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
participants must be able to read, write, and converse in english.
Description

Able to read English Language | Able to write English Language | Able to make conversation English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0566059
UMLS CUI [3,2]
C0376245
participants will have a diagnosis of hypertension (based on participant report).
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
participants will have an active prescription for at least one antihypertensive medication with no antihypertensive prescription changes for 30 days at the time of study entry.
Description

Antihypertensive Agents Quantity prescribed | Change of prescription Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278329
UMLS CUI [2,1]
C0199250
UMLS CUI [2,2]
C0332197
participants must self-administer his or her own medications without prompts from any other person or device.
Description

Taking self-administered medication

Data type

boolean

Alias
UMLS CUI [1]
C3835570
baseline medication adherence rate of < 85%.
Description

Pharmaceutical Preparations Adherence Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1510802
UMLS CUI [1,3]
C0439165
participants must be free of cognitive deficit as determined by a score of "normal" (0 - 2) on the short portable mental status questionnaire (spmsq).
Description

Cognitive deficits Free of Mental status questionnaire | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0009241
UMLS CUI [1,2]
C0332296
UMLS CUI [1,3]
C0451291
UMLS CUI [2]
C3846158
participants agree to complete all study contacts and measurements, including the use a special medication bottle with a medication event monitoring system (mems) cap for the duration of the study.
Description

Protocol Compliance | Use of MEMS Cap

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C2600049
able to open and close mems caps.
Description

MEMS Cap Usage Able

Data type

boolean

Alias
UMLS CUI [1,1]
C2600049
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant is in state of severe hypertension (bp of >180/120 mmhg) at the time of study enrollment. participants presenting with severely elevated blood pressure will be referred to their primary care provider.
Description

Hypertension, severe | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0005824
participant resides in a residential facility where medications are administered by facility staff. participants who reside in assisted living facilities but maintain control of their medications remain eligible.
Description

Resident Residential Facility | Nursing Staff Responsibility Administration of medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0035186
UMLS CUI [2,1]
C0028698
UMLS CUI [2,2]
C0678341
UMLS CUI [2,3]
C3469597
participant has a terminal chronic illness with a life expectancy of six months or less.
Description

Terminal illness chronic | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679247
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0023671
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Similar models

Eligibility Hypertension NCT00688350

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participants will be aged 60 years or greater at time of study entry.
boolean
C0001779 (UMLS CUI [1])
Able to read English Language | Able to write English Language | Able to make conversation English Language
Item
participants must be able to read, write, and converse in english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0566059 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Hypertensive disease
Item
participants will have a diagnosis of hypertension (based on participant report).
boolean
C0020538 (UMLS CUI [1])
Antihypertensive Agents Quantity prescribed | Change of prescription Absent
Item
participants will have an active prescription for at least one antihypertensive medication with no antihypertensive prescription changes for 30 days at the time of study entry.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
C0199250 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Taking self-administered medication
Item
participants must self-administer his or her own medications without prompts from any other person or device.
boolean
C3835570 (UMLS CUI [1])
Pharmaceutical Preparations Adherence Percentage
Item
baseline medication adherence rate of < 85%.
boolean
C0013227 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Cognitive deficits Free of Mental status questionnaire | Other Coding
Item
participants must be free of cognitive deficit as determined by a score of "normal" (0 - 2) on the short portable mental status questionnaire (spmsq).
boolean
C0009241 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0451291 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Protocol Compliance | Use of MEMS Cap
Item
participants agree to complete all study contacts and measurements, including the use a special medication bottle with a medication event monitoring system (mems) cap for the duration of the study.
boolean
C0525058 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C2600049 (UMLS CUI [2,2])
MEMS Cap Usage Able
Item
able to open and close mems caps.
boolean
C2600049 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Blood pressure determination
Item
participant is in state of severe hypertension (bp of >180/120 mmhg) at the time of study enrollment. participants presenting with severely elevated blood pressure will be referred to their primary care provider.
boolean
C4013784 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Resident Residential Facility | Nursing Staff Responsibility Administration of medication
Item
participant resides in a residential facility where medications are administered by facility staff. participants who reside in assisted living facilities but maintain control of their medications remain eligible.
boolean
C2347958 (UMLS CUI [1,1])
C0035186 (UMLS CUI [1,2])
C0028698 (UMLS CUI [2,1])
C0678341 (UMLS CUI [2,2])
C3469597 (UMLS CUI [2,3])
Terminal illness chronic | Life Expectancy
Item
participant has a terminal chronic illness with a life expectancy of six months or less.
boolean
C0679247 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
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