Clinical trial NCT02776566: Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
Official title: Patient-Centered Anticoagulation Self-Monitoring in Minority Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Roche Pharma AG
First posted: 2016-05-18
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent time in therapeutic range (TTR)
timeFrame: Month 1, Month 2, Month 4, Month 7
Secondary outcomes:
measure: Treatment Related Quality of Life
timeFrame: Baseline, Month 1, Month 7
measure: Anticoagulation Related Knowledge
timeFrame: Baseline, Month 1, Month 7
measure: Adherence with Monitoring
timeFrame: Month 1, Month 2, Month 4, Month 7
measure: Self-Testing Competency (Intervention group only)
timeFrame: Baseline to 7 months
measure: Self-Testing Accuracy (Intervention group only)
timeFrame: Baseline to 7 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Edith A Nutescu, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References: