Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

Mayo Clinic

Status: Completed

Conditions: Management of Anticoagulation

Treatments: Device: INRatio monitor by Hemosense; Other: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00703963

07-001398

Details and patient eligibility

About

Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.

The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.

Full description

Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.

The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.

Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients that received a mechanical valve while in our hospital
• Age > 18 years

Exclusion criteria

• Pregnant or lactating women
• Patients that have genetic clotting disorders such as Factor 5
• Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.

Treatment:

Other: Usual Care

Patient Self Testing

Active Comparator group

Description:

Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.

Treatment:

Device: INRatio monitor by Hemosense