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Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

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ClinicalTrials.gov Identifier: NCT02776566
Recruitment Status : Unknown
Verified May 2016 by Edith A. Nutescu, University of Illinois at Chicago.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Roche Pharma AG
Information provided by (Responsible Party):
Edith A. Nutescu, University of Illinois at Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Thromboembolism Blood Coagulation Disorders Cardiovascular Disease Vascular Disease Other: Patient Self-Monitoring vs Anticoagulation Clinic Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
Study Start Date : January 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Active Comparator: Anticoagulation Clinic

Usual care through pharmacist managed anticoagulation clinic

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.

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.


Experimental: Patient Self-Monitoring

In home self-monitoring and pharmacist guided education

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.

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776566


Contacts
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Contact: ChoAh Kim, PharmD 312-996-2520 ckim60@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Edith A Nutescu, PharmD, MS    312-996-0880    enutescu@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Roche Pharma AG
Investigators
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Principal Investigator: Edith A Nutescu, PharmD, MS University of Illinois at Chicago

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Responsible Party: Edith A. Nutescu, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02776566     History of Changes
Other Study ID Numbers: 2015-1193
K23HL112908 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Edith A. Nutescu, University of Illinois at Chicago:
Warfarin
Anticoagulation
Anticoagulation Management
Self-Testing
Self-Management
Thromboembolism
Blood Coagulation Disorders
Health Disparities
Minorities
African American
Hispanic
Cardiovascular Disease
Models of Anticoagulation Care
Tele-Health
Home Self-Testing
Additional relevant MeSH terms:
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Thromboembolism
Vascular Diseases
Hemostatic Disorders
Blood Coagulation Disorders
Cardiovascular Diseases
Embolism and Thrombosis
Hematologic Diseases
Hemorrhagic Disorders
Warfarin
Anticoagulants