ID

29445

Description

A Strategy of Home Telehealth for Management of Congestive Heart Failure(STARTEL); ODM derived from: https://clinicaltrials.gov/show/NCT00247000

Link

https://clinicaltrials.gov/show/NCT00247000

Keywords

Versions (1)
  1. 3/25/18 3/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00247000

English

Eligibility Heart Failure NCT00247000

1 forms  
Criteria
Description

Criteria

1. male or female subject’s ≥ 18 years of age with a diagnosis of heart failure
Description

Age | Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018801
2. subject must reside in either the province of nova scotia or new brunswick
Description

Residence

Data type

boolean

Alias
UMLS CUI [1]
C0237096
3. subject has been hospitalized for heart failure during the past two years or has a known history of heart failure for a minimum of two years.
Description

Hospitalization Heart failure | Heart failure Disease length Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0872146
UMLS CUI [2,3]
C1524031
4. subject must have a dedicated working telephone line in their primary place of residence.
Description

Residence Work Telephone

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0043227
UMLS CUI [1,3]
C0039457
5. subject must have a grounded electrical power supply in their primary place of residence.
Description

Residence Electrical Power Systems

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0181422
6. primary care physician provides their agreement to participate in startel
Description

Study Subject Participation Status | Primary Care Physician Agreement

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0033131
UMLS CUI [2,2]
C0680240
exclusion criteria: patients are not eligible for participating in startel if they meet any of the following exclusion criteria.
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. inability to understand the english or french language or understand the study and provide informed consent.
Description

Comprehension English Language Unable | Comprehension French language Unable | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376246
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
2. absence of a suitable area to conduct the home telehealth visit in the patient's place of residence.
Description

Telehealth Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C1328956
UMLS CUI [1,2]
C1272705
3. physical impairment, which would prohibit the successful completion of a home telehealth visit, including attachment of the peripheral equipment (bp cuff, ability to stand on a scale, etc).
Description

Physical impairment Preventing Telehealth | Equipment use Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0231171
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1328956
UMLS CUI [2,1]
C1301714
UMLS CUI [2,2]
C1272705
4. in cases 1 & 3 only: a live in caregiver whose presence may overcome these limitations may allow the patient to be included in the study, however, only the patient's next of kin or duly appointed guardian (with documentation and with patient assent) may provide informed consent to participate).
Description

Caregiver Assistance allowed | Informed Consent Kinship allowed | Informed Consent Guardian allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C1269765
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0680081
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
UMLS CUI [3,3]
C0683607
5. subject has a planned cardiac procedure such as open-heart surgery or percutaneous coronary intervention (pci) within the next 6 months.
Description

Procedure on heart Planned | Open heart surgery Planned | Percutaneous Coronary Intervention Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1279986
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0189745
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
6. subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis of acute myocardial infarction within 1 month before randomization).
Description

Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0027051
7. condition where existing routine follow up occurs more than once weekly (i.e. hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .
Description

Follow-up Frequency | Hemodialysis | Cancer treatment | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0439603
UMLS CUI [2]
C0019004
UMLS CUI [3]
C0920425
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1522449
8. patient is institutionalized (includes chronic care facility)
Description

Patient Institutionalized | Health care facility chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0562359
UMLS CUI [2,1]
C0018704
UMLS CUI [2,2]
C0205191
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Similar models

Eligibility Heart Failure NCT00247000

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age | Heart failure
Item
1. male or female subject’s ≥ 18 years of age with a diagnosis of heart failure
boolean
C0001779 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
Residence
Item
2. subject must reside in either the province of nova scotia or new brunswick
boolean
C0237096 (UMLS CUI [1])
Hospitalization Heart failure | Heart failure Disease length Minimum
Item
3. subject has been hospitalized for heart failure during the past two years or has a known history of heart failure for a minimum of two years.
boolean
C0019993 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
Residence Work Telephone
Item
4. subject must have a dedicated working telephone line in their primary place of residence.
boolean
C0237096 (UMLS CUI [1,1])
C0043227 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
Residence Electrical Power Systems
Item
5. subject must have a grounded electrical power supply in their primary place of residence.
boolean
C0237096 (UMLS CUI [1,1])
C0181422 (UMLS CUI [1,2])
Study Subject Participation Status | Primary Care Physician Agreement
Item
6. primary care physician provides their agreement to participate in startel
boolean
C2348568 (UMLS CUI [1])
C0033131 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
Exclusion Criteria
Item
exclusion criteria: patients are not eligible for participating in startel if they meet any of the following exclusion criteria.
boolean
C0680251 (UMLS CUI [1])
Comprehension English Language Unable | Comprehension French language Unable | Informed Consent Unable
Item
1. inability to understand the english or french language or understand the study and provide informed consent.
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Telehealth Unsuccessful
Item
2. absence of a suitable area to conduct the home telehealth visit in the patient's place of residence.
boolean
C1328956 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Physical impairment Preventing Telehealth | Equipment use Unsuccessful
Item
3. physical impairment, which would prohibit the successful completion of a home telehealth visit, including attachment of the peripheral equipment (bp cuff, ability to stand on a scale, etc).
boolean
C0231171 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1328956 (UMLS CUI [1,3])
C1301714 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Caregiver Assistance allowed | Informed Consent Kinship allowed | Informed Consent Guardian allowed
Item
4. in cases 1 & 3 only: a live in caregiver whose presence may overcome these limitations may allow the patient to be included in the study, however, only the patient's next of kin or duly appointed guardian (with documentation and with patient assent) may provide informed consent to participate).
boolean
C0085537 (UMLS CUI [1,1])
C1269765 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0680081 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Procedure on heart Planned | Open heart surgery Planned | Percutaneous Coronary Intervention Planned
Item
5. subject has a planned cardiac procedure such as open-heart surgery or percutaneous coronary intervention (pci) within the next 6 months.
boolean
C1279986 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0189745 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Cardiac Surgery procedures | Percutaneous Coronary Intervention | Myocardial Infarction
Item
6. subject has had cardiac surgery, percutaneous coronary intervention or a diagnosis of acute myocardial infarction within 1 month before randomization).
boolean
C0018821 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Follow-up Frequency | Hemodialysis | Cancer treatment | Chemotherapy | Therapeutic radiology procedure
Item
7. condition where existing routine follow up occurs more than once weekly (i.e. hemodialysis, cancer treatment including: chemotherapy/radiation treatment). .
boolean
C1522577 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Patient Institutionalized | Health care facility chronic
Item
8. patient is institutionalized (includes chronic care facility)
boolean
C0030705 (UMLS CUI [1,1])
C0562359 (UMLS CUI [1,2])
C0018704 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
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