Skip to main content
OpenTrials
Completed

NCT Number: NCT02776566

Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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:

  • Identify patient and provider factors that influence adoption of anticoagulation self-monitoring in a minority population.
  • Adapt and refine an education intervention that both addresses identified barriers and emphasizes identified positive influences to anticoagulation self-monitoring.
  • Demonstrate the feasibility and effectiveness of anticoagulation self-monitoring coupled with an educational intervention in a minority population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Self-Monitoring vs Anticoagulation Clinic

Other

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.

Primary outcomes

  1. Percent time in therapeutic range (TTR)

    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

Secondary outcomes

  1. Treatment Related Quality of Life

    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

  2. Anticoagulation Related Knowledge

    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.

  3. Adherence with Monitoring

    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.

  4. Self-Testing Competency (Intervention group only)

    Time frame: Baseline to 7 months

    It is defined as the ability to attain an INR reading and provider observed technique.

  5. Self-Testing Accuracy (Intervention group only)

    Time frame: Baseline to 7 months

    It is defined as the concordance of self-reported and device-stored INR measurements.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Roche Pharma AG

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 18, 2016
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.