Cardiovascular Diseases Clinical Trial
— mCVRSOfficial title:
Design and Testing of a Mobile Cardiovascular Risk Service With Patient Partners
Verified date | October 2018 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Risk factors for cardiovascular disease are poorly controlled even for patients who frequently visit their physician, leading to large numbers of preventable cardiovascular events such as heart attacks and strokes. Research from integrated healthcare systems suggests that risk factors can be controlled better and treatment strategies for cardiovascular disease can be markedly improved by using a centralized cardiovascular risk service (CVRS) managed by pharmacists. The investigators are confident that a pharmacist-managed mHealth CVRS can become a strategy in un-integrated healthcare settings to markedly reduce cardiovascular events in the United States.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 99 Years |
Eligibility |
INCLUSION CRITERIA: 1. Patients age 55 and older; 2. Owns and uses a smartphone; 3. Any ONE of the following guideline-related needs in the past 18 months: 1. Most recent encounter LDL >= 100 mg/dl 2. Most recent encounter BP > 140/90 mmHg (or > 150/90 for persons age 60+) 3. Most recent encounter not taking recommended post-stroke medications 4. Most recent encounter not taking recommended post-MI medications 5. Diabetics with most recent encounter not on ACE inhibitor or ARB blocker 6. Any patient with most recent A1c > 8.0% 7. Diabetics with no urine microalbumin screening, past 18 months EXCLUSION CRITERIA: 1. Non-English speaking (app available only in English for this study) 2. No encounter in the past 18 months (they may be receiving care elsewhere and guideline-related needs may not be reliably assessed) at the clinic itself 3. Most recent systolic BP >200 or diastolic BP > 110 mm Hg 4. Any history of significant hepatic disease, including cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST > 3 times normal (either AST above 96 U/L or ALT above 99 U/L or total bilirubin > 2.0 mg/dl)) 5. History of hemorrhagic stroke 6. Pulmonary hypertension 7. Stage 4 or metastatic cancer 8. Current nursing home residence or has plans to move to one within the next 12 months 9. Has plans to transfer care from the current clinic within the next 6 months 10. Inability to give informed consent or impaired cognitive function 11. Currently pregnant (females only) 12. Currently a prisoner |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
United States | Siouxland Community Health Center | Sioux City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site) | Mean number of days on which a patient interacts with the cardiovascular risk service (using either mobile app or web-site) | 4 months post enrollment | |
Primary | Mean number of contacts with a pharmacist | Mean number of contacts with a pharmacist | 4 months post enrollment | |
Secondary | Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention | Guideline Adherence score calculated on the subset of guidelines amenable to intervention during the 4 month intervention | 4 months post enrollment |
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