University of Illinois at Chicago
Chicago, Illinois, 60612, United States
NCT Number: NCT02776566
The purpose of this study is to demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority underserved population.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Despite favorable results and enhanced patient convenience, the adoption of patient self-monitoring for anticoagulation therapy has been limited primarily to non-minority and higher socioeconomic status individuals. While effectiveness has been studied, the factors influencing the adoption of self-monitoring of anticoagulation in minorities with the most barriers to accessing quality care in specialized clinics, are not known.
Hypothesis: Patient centered education and training intervention for minority patients will result in effective adoption of self-monitoring of anticoagulation therapy, resulting in anticoagulation control of comparable quality to that seen in specialized anticoagulation clinic-based monitoring.
The research objective of this proposal will be accomplished through 3 specific aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.
Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic.
Time frame: Month 1, Month 2, Month 4, Month 7
TTR will be calculated for each patient using the linear interpolation method. This method has been associated with clinical outcomes such as risk for thromboembolic events, and thus was selected over other methods of expressing the TTR such as fraction of International Normalized Ratio (INR) in range and cross-section of files
Time frame: Baseline, Month 1, Month 7
It will be evaluated using a 25 item validated questionnaire that assesses limitations, hassles, and positive impact with a Cronbach alpha for each of 0.87, 0.88 and 0.78 respectively
Time frame: Baseline, Month 1, Month 7
It will be measured with an instrument containing 29 items at different levels of difficulty to allow differences in patient knowledge to be evaluated and has a person reliability coefficient of 0.75.
Time frame: Month 1, Month 2, Month 4, Month 7
It is defined as the INR test completed within 24 hours of scheduled time and measured via the Coaguchek® device in home or clinic.
Time frame: Baseline to 7 months
It is defined as the ability to attain an INR reading and provider observed technique.
Time frame: Baseline to 7 months
It is defined as the concordance of self-reported and device-stored INR measurements.
University of Illinois at Chicago
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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