Patient-Centered Anticoagulation Self-Monitoring in Minority Patients

NCT02776566 | Completed

• 2 other identifiers: 2015-1193K23HL112908
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism; Blood Coagulation Disorders; Cardiovascular Disease; Vascular Disease

Keywords

Anticoagulation; Anticoagulation Management; Self-Testing; Self-Management; Warfarin; Thromboembolism; Blood Coagulation Disorders; Health Disparities; Minorities; African American; Hispanic; Cardiovascular Disease; Models of Anticoagulation Care; Tele-Health; Home Self-Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment Related Quality of Life

  Baseline, Month 1, Month 7

• Anticoagulation Related Knowledge

  Baseline, Month 1, Month 7

• Adherence with Monitoring

  Month 1, Month 2, Month 4, Month 7

• Self-Testing Competency (Intervention group only)

  Baseline to 7 months

• Self-Testing Accuracy (Intervention group only)

  Baseline to 7 months

Study Arms (2)

Anticoagulation Clinic

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

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.

Anticoagulation Clinic; Patient Self-Monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Thromboembolism; Blood Coagulation Disorders; Cardiovascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Edith A Nutescu, PharmD, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: May 18, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

US (1)