Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

Cardiovascular Disease Clinical Trial

Official title:

Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776566
• Other study ID #: 2015-1193
• Secondary ID: K23HL112908
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2019

Study information

• Verified date: August 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.

2. Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.

3. Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• > 21 years of age

• African American or Hispanic

• English speaking

• Has been on warfarin therapy > 3 months

• Plan to be on warfarin therapy > 12 months

• Willing ( or caregiver be willing) to do self-monitoring

• Willing to be randomized

Exclusion Criteria:

• Lack of access to a telephone

• Moderate to severe dementia (if lacks caregiver)

• Severe hearing impairment ( if lacks caregiver)

• Blindness ( if lacks caregiver)

• Life expectancy < 6 months

• Antiphospholipid antibody syndrome

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cardiovascular Disease
• Cardiovascular Diseases
• Hemostatic Disorders
• Thromboembolism
• Vascular Disease
• Vascular Diseases

Intervention

Other:
• Patient Self-Monitoring vs Anticoagulation Clinic
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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI), Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent time in therapeutic range (TTR)	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	Month 1, Month 2, Month 4, Month 7
Secondary	Treatment Related Quality of Life	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	Baseline, Month 1, Month 7
Secondary	Anticoagulation Related Knowledge	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.	Baseline, Month 1, Month 7
Secondary	Adherence with Monitoring	It is defined as the INR test completed within 24 hours of scheduled time and measured via the Coaguchek® device in home or clinic.	Month 1, Month 2, Month 4, Month 7
Secondary	Self-Testing Competency (Intervention group only)	It is defined as the ability to attain an INR reading and provider observed technique.	Baseline to 7 months
Secondary	Self-Testing Accuracy (Intervention group only)	It is defined as the concordance of self-reported and device-stored INR measurements.	Baseline to 7 months