Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care "ICARE"
Active, not recruiting
Phase N/A Results N/AUpdate History
10 Mar '18 |
The Summary of Purpose was updated. New
The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service
(PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary
care offices and whether it can improve the care delivered to patients at risk for developing
cardiovascular disease. The study will be conducted in 12 medical practices in Iowa that are
either a Federally Qualified Health Center or part of the IRENE practice-based research
network.
Old
The trial will examine whether a centralized Prevention Health & Cardiovascular Risk Service
(PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary
care offices and whether it can improve the care delivered to patients at risk for
developing cardiovascular disease. The study will be conducted in 12 medical practices in
Iowa that are either a Federally Qualified Health Center or part of the IRENE practice-based
research network.
The gender criteria for eligibility was updated to "All." The eligibility criteria were updated. New
INCLUSION CRITERIA
Section A: Demographic Criteria
1. Patient was seen in your clinic or practice at least once in the past 24 months
2. English-speaking male or female
3. Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
4. Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
5. Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140
otherwise
6. Elevated blood pressure with:
- Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic
kidney disease OR
- Systolic BP >= 150 in persons with uncomplicated hypertension
Section C: Cardiovascular Conditions - total number of risk factors in Section B
(above) plus number of conditions Section C (below) must be THREE OR MORE
7. History of coronary artery disease
8. Previous Heart Attack
9. History of Stroke
10. History of Transient Ischemic Attack
11. History of Atrial fibrillation
12. History of Peripheral Vascular Disease / claudication
13. History of carotid artery disease
14. Current smoker
15. Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
16. Inability to give informed consent
17. Pregnant
18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
19. Cancer diagnosis with a life expectancy estimated less than 2 years
20. Residence in a nursing home or diagnosis of dementia
21. No telephone or a hearing impairment not allowing them to use a phone
22. Refusal to consider attempting to use the internet at home, community center, library,
medical office or other source to access the PHRM
23. Patient has plans to move from the area or transfer care to a different clinic in the
next 12 months
24. Omron blood pressure cuff cannot be used on patient's arm for any reason
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INCLUSION CRITERIA
Section A: Demographic Criteria
1. Patient was seen in your clinic or practice at least once in the past 24 months
2. English-speaking male or female
3. Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
4. Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
5. Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or >
140 otherwise
6. Elevated blood pressure with:
- Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic
kidney disease OR
- Systolic BP >= 150 in persons with uncomplicated hypertension
Section C: Cardiovascular Conditions - total number of risk factors in Section B
(above) plus number of conditions Section C (below) must be THREE OR MORE
7. History of coronary artery disease
8. Previous Heart Attack
9. History of Stroke
10. History of Transient Ischemic Attack
11. History of Atrial fibrillation
12. History of Peripheral Vascular Disease / claudication
13. History of carotid artery disease
14. Current smoker
15. Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
16. Inability to give informed consent
17. Pregnant
18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
19. Cancer diagnosis with a life expectancy estimated less than 2 years
20. Residence in a nursing home or diagnosis of dementia
21. No telephone or a hearing impairment not allowing them to use a phone
22. Refusal to consider attempting to use the internet at home, community center,
library, medical office or other source to access the PHRM
23. Patient has plans to move from the area or transfer care to a different clinic in the
next 12 months
24. Omron blood pressure cuff cannot be used on patient's arm for any reason
|
5 Jun '15 |
The eligibility criteria were updated. New
INCLUSION CRITERIA
Section A: Demographic Criteria
1. Patient was seen in your clinic or practice at least once in the past 24 months
2. English-speaking male or female
3. Age is 50 or older at medical record screening
Section B: Risk Factors - Must have at least one of the following conditions
4. Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
5. Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or >
140 otherwise
6. Elevated blood pressure with:
- Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic
kidney disease OR
- Systolic BP >= 150 in persons with uncomplicated hypertension
Section C: Cardiovascular Conditions - total number of risk factors in Section B
(above) plus number of conditions Section C (below) must be THREE OR MORE
7. History of coronary artery disease
8. Previous Heart Attack
9. History of Stroke
10. History of Transient Ischemic Attack
11. History of Atrial fibrillation
12. History of Peripheral Vascular Disease / claudication
13. History of carotid artery disease
14. Current smoker
15. Obesity with BMI > 30
EXCLUSION CRITERIA
Section D: Exclusion Criteria - has NONE of the following:
16. Inability to give informed consent
17. Pregnant
18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
19. Cancer diagnosis with a life expectancy estimated less than 2 years
20. Residence in a nursing home or diagnosis of dementia
21. No telephone or a hearing impairment not allowing them to use a phone
22. Refusal to consider attempting to use the internet at home, community center,
library, medical office or other source to access the PHRM
23. Patient has plans to move from the area or transfer care to a different clinic in the
next 12 months
24. Omron blood pressure cuff cannot be used on patient's arm for any reason
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Inclusion Criteria:
- Must have at least one of the following conditions
- Uncontrolled diabetes (Hemoglobin A1c > or + 7.5
- Elevated LDL cholesterol > 110 for patients with stroke or diabetes or > 140
otherwise
- Elevated blood pressure with systolic pressure 140 or higher in persons who have
diabetes or chronic kidney disease and 150 or higher otherwise.
- Persons who have only one or two of the conditions listed above must also have had
one or more of the following conditions, so that the total number of conditions is at
least three:
- Coronary Artery Disease
- Previous Heart Attack
- Stroke or Transient Ischemic Attack
- Atrial fibrillation
- Peripheral Vascular Disease
- Smoker
- Obesity
Exclusion Criteria:
-
|
2 May '14 |
A location was updated in Riverside. New The overall status was removed for UI Health Care-River Crossing. |
View Trial Locations
Recruitment
- Enrollment: 302
- Gender: All
- Minimum Age: 50 Years
- Accepts Healthy Volunteers: No
- 12 locations, 1 country
Principal Investigators
- Barry L. Carter, Pharm.D.
University of Iowa
- Barcey T. Levy, M.D., Ph.D.
University of Iowa